Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06817024 in healthy volunteers, in participants with chronic rhinosinusitis, with nasal polyps and in participants with moderate-to-severe Atopic Dermatitis
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
The purpose of the study for Part 1 is to evaluate the safety and tolerability of PF-06817024 in healthy subjects.
The purpose of the study for Part 2 is to evaluate the safety and tolerability of PF-06817024 in patients with chronic rhinosinusitis with nasal polyps.
The purpose of the study for Part 3 is to evaluate the safety and tolerability of PF-06817024 in patients with moderate-to-severe Atopic Dermatitis
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Cohort 1 10 mg of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
|
Experimental: Cohort 2 30 mg of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
|
Experimental: Cohort 3 100 mg of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given two doses of PF-06817024 intravenously
|
Experimental: Cohort 4 300 mg of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
|
Experimental: Cohort 5 1000 mg of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
|
Experimental: Cohort 6 2000 mg of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
|
Experimental: Cohort 7 30 mg subcutaneous dose of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 subcutaneously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 subcutaneously
|
Experimental: Cohort 8 300 mg of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
|
Experimental: Cohort 9 IV dose to be determined of PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given one dose of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given one dose of placebo for PF-06817024 intravenously
|
Experimental: Cohort 10 PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given 2 doses intravenously
Other: Placebo for PF-06817024
Subjects will be given 2 doses intravenously
|
Experimental: Cohort 11 PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given 2 doses intravenously
Other: Placebo for PF-06817024
Subjects will be given 2 doses intravenously
|
Experimental: Cohort 12 PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given 2 doses intravenously
Other: Placebo for PF-06817024
Subjects will be given 2 doses intravenously
|
Experimental: Cohort 13 PF-06817024 or placebo |
Biological: PF-06817024
Subjects will be given doses of PF-06817024 intravenously
Other: Placebo for PF-06817024
Subjects will be given doses of Placebo intravenously
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part 1 [From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).]
An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
- Number of Participants With Treatment-Related TEAEs and SAEs in Part 1 [From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).]
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.
- Number of All-Causality TEAEs According to Severity in Part 1 [From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.
- Number of Participants With Permanent Discontinuation Due to TEAEs in Part 1 [From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7).]
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.
- Number of Participants With All-Causality TEAEs and SAEs in Part 2 [From Study Day 1 (baseline) up to Day 691.]
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
- Number of Participants With Treatment-Related TEAEs and SAEs in Part 2 [From Study Day 1 (baseline) up to Day 691.]
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.
- Number of All-Causality TEAEs According to Severity in Part 2 [From Study Day 1 (baseline) up to Day 691.]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.
- Number of Participants With Permanent Discontinuation Due to TEAEs in Part 2 [From Study Day 1 (baseline) up to Day 691.]
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.
- Number of Participants With All-Causality TEAEs and SAEs in Part 3 [From Study Day 1 (baseline) up to Day 1105.]
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect.
- Number of Participants With Treatment-Related TEAEs and SAEs in Part 3 [From Study Day 1 (baseline) up to Day 1105.]
An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator.
- Number of All-Causality TEAEs According to Severity in Part 3 [From Study Day 1 (baseline) up to Day 1105.]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function.
- Number of Participants With Permanent Discontinuation Due to TEAEs in Part 3 [From Study Day 1 (baseline) up to Day 1105.]
An AE was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state.
- Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 1 [Part 1 single-dose cohorts: from Study Day 1 (baseline) up to Day 211. Part 1 multiple-dose cohorts: from Study Day 1 (baseline) up to Day 241.]
Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.
- Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 2 [Part 2: from Study Day 1 (baseline) up to Day 211.]
Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.
- Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 3 [Part 3: from Study Day 1 (baseline) up to Day 966.]
Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here.
- Number of Participants With Vital Sign Abnormalities in Part 1 [Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts).]
Criteria for abnormality in vital signs: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine diastolic blood pressure (DBP) <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg; supine systolic blood pressure (SBP) <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
- Number of Participants With Vital Sign Abnormalities in Part 2 [Study Day 1 (baseline) up to end of study (Study Day 211).]
Criteria for abnormality in vital signs: supine pulse rate <40 bpm or >120 bpm; supine DBP <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg; supine SBP <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
- Number of Participants With Vital Sign Abnormalities in Part 3 [Study Day 1 (baseline) up to end of study (Study Day 337).]
Criteria for abnormality in vital signs: supine pulse rate <40 bpm or >120 bpm; supine DBP <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg; supine SBP <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here.
- Number of Participants With Electrocardiogram (ECG) Abnormalities in Part 1 [Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts).]
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450<= QTcF <480, 480<= QTcF <500, and QTcF >=500; QTcF maximum increase from baseline(msec): 30<= change <60, and change >=60; 2) maximum PR interval (msec): >=300; PR increase from baseline (msec): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (msec): >=140; QRS increase from baseline (msec) >=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
- Number of Participants With ECG Abnormalities in Part 2 [Study Day 1 (baseline) up to end of study (Study Day 211).]
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450<= QTcF <480, 480<= QTcF <500, and QTcF >=500; QTcF maximum increase from baseline(msec): 30<= change <60, and change >=60; 2) maximum PR interval (msec): >=300; PR increase from baseline (msec): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (msec): >=140; QRS increase from baseline (msec) >=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
- Number of Participants With ECG Abnormalities in Part 3 [Study Day 1 (baseline) up to end of study (Study Day 337).]
ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450<= QTcF <480, 480<= QTcF <500, and QTcF >=500; QTcF maximum increase from baseline(msec): 30<= change <60, and change >=60; 2) maximum PR interval (msec): >=300; PR increase from baseline (msec): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (msec): >=140; QRS increase from baseline (msec) >=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here.
Secondary Outcome Measures
- Maximum Observed Serum Concentration (Cmax) of PF-06817024 Following Single Dose in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).]
Maximum observed serum concentration (Cmax) of PF-06817024 following single dose in Part 1; Cmax was defined as the maximum observed serum concentration.
- Cmax of PF-06817024 Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Cmax was defined as the maximum observed serum concentration.
- Cmax of PF-06817024 in Part 2 [Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).]
Cmax was defined as the maximum observed serum concentration.
- Cmax of PF-06817024 in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
Cmax was defined as the maximum observed serum concentration.
- Dose Normalized Maximum Observed Serum Concentration (Cmax[dn]) of PF-06817024 Following Single Dose in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).]
Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
- Cmax(dn) of PF-06817024 Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Cmax(dn) was defined as dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
- Cmax(dn) of PF-06817024 in Part 2 [Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).]
Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
- Cmax(dn) of PF-06817024 in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration.
- Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06817024 Following Single Dose in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).]
Time to reach maximum observed serum concentration (Tmax) of PF-06817024 in Part 1; Tmax was defined as time to reach maximum observed serum concentration.
- Tmax of PF-06817024 Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Tmax was defined as time to reach maximum observed serum concentration.
- Tmax of PF-06817024 in Part 2 [Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).]
Tmax was defined as time to reach maximum observed serum concentration.
- Tmax of PF-06817024 in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
Tmax was defined as time to reach maximum observed serum concentration.
- Area Under the Curve From Time Zero to Infinity Concentration (AUCinf) of PF-06817024 Following Single Dose in Part 1 and 2 [Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151.]
Area under the curve from time zero to infinity concentration (AUCinf) of PF-06817024 following single dose in Part 1 and 2; AUCinf was defined as area under the curve from time zero to infinity concentration.
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06817024 Following Single Dose in Part 1 and 2 [Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151.]
Area under the curve from time zero to last quantifiable concentration (AUClast) of PF-06817024 following single dose in Part 1 and 2; AUClast was defined as area under the curve from time zero to last quantifiable concentration.
- Area Under the Curve Within Dosing Interval (AUCtau) of PF-06817024 Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Area under the curve within dosing interval (AUCtau) of PF-06817024 following multiple doses in Part 1; AUCtau was defined as area under the curve within dosing interval. The dosing interval was 720 hours.
- AUCtau of PF-06817024 in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
AUCtau was defined as area under the curve within dosing interval. The dosing interval was 672 hours.
- Dose Normalized Area Under the Curve Within Dosing Interval (AUCtau[dn]) of PF-06817024 Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Dose normalized area under the curve within dosing interval (AUCtau[dn]) of PF-06817024 following multiple doses in Part 1; AUCtau(dn) was defined as dose normalized area under the curve within dosing interval. The dosing interval was 720 hours.
- AUCtau(dn) of PF-06817024 Following Multiple Doses in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
AUCtau(dn) was defined as dose normalized area under the curve within dosing interval. The dosing interval was 672 hours.
- Average Concentration Over Dosing Interval (Cav) of PF-06817024 Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Average concentration over dosing interval (Cav) of PF-06817024 following multiple doses in Part 1; Cav was defined as average concentration over dosing interval. The dosing interval was 720 hours.
- Cav of PF-06817024 Following Multiple Doses in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
Cav was defined as average concentration over dosing interval. The dosing interval was 672 hours.
- Terminal Elimination Half Life (t1/2) of PF-06817024 Following Single Dose in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).]
t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
- t1/2 of PF-06817024 Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
T1/2 of PF-06817024 following multiple doses in Part 1; t1/2 was defined as terminal elimination half life.
- t1/2 of PF-06817024 in Part 2 [Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose).]
t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
- t1/2 of PF-06817024 in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. For Part 3 Cohort 13: PF-06817024 600 mg + 300 mg IV AD, t1/2 of the last dose on Day 85 was reported in the table.
- Apparent Volume of Distribution (Vz/F) of PF-06817024 for the Subcutaneous Cohort in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).]
Apparent volume of distribution (Vz/F) of PF-06817024 for the subcutaneous cohort in Part 1; Vz/F was defined as apparent volume of distribution.
- Apparent Clearance (CL/F) of PF-06817024 for the Subcutaneous Cohort in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose).]
Apparent clearance (CL/F) of PF-06817024 for the subcutaneous cohort in Part 1; CL/F was defined as apparent clearance.
- Volume of Distribution at Steady State (Vss) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2 [Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151.]
Volume of distribution at steady state (Vss) of PF-06817024 following a single dose in Part 1 and Part 2; Vss was defined as volume of distribution at steady state.
- Clearance (CL) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2 [On Day 1 at pre-dose, post-dose 1, 2, 4, 8, 12, 24, 96 hour, Day 8, 15, 32, 61, 91, 121,181, 211, 241, 331, and 421. For Part 1 only: at post-dose 48 and 72 hour, Day 46 and 151. For Part 2 only: on Day 511, 601, and 691.]
CL was defined as Clearance, calculated by Dose/AUCinf. AUCinf was defined as area under the curve from time zero to infinity concentration.
- Trough Serum Concentration (Cmin) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 [At pre-dose on Day 31 or Day 46.]
Trough serum concentration (Cmin) of PF-06817024 post second dose following multiple doses in Part 1; Cmin was defined as the trough serum concentration.
- Cmin of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 [At pre dose (0 hour) on Day 85.]
Cmin of PF-06817024 post last dose following multiple doses in Part 3; Cmin was defined as the trough serum concentration.
- Accumulation Ratio for Cmax (Rac, Cmax) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Rac, Cmax was defined as accumulation ratio for Cmax, and was calculated by (Cmax on Day 31 or Day 46) / Cmax on Day 1. Cmax was defined as the maximum observed serum concentration.
- Rac, Cmax of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
Rac, Cmax was defined as accumulation ratio for Cmax, and was calculated by (Cmax on Day 85) / (Cmax on Day 1). Cmax was defined as the maximum observed serum concentration.
- Accumulation Ratio for AUCtau (Rac) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 [Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose).]
Rac was defined as accumulation ratio for AUCtau. AUCtau was defined as area under the curve within dosing interval. The dosing interval was 720 hours.
- Rac of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 [On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85).]
Rac was defined as accumulation ratio for AUCtau. AUCtau was defined as area under the curve within dosing interval. The dosing interval was 672 hours.
- Number of Participants With Treatment-Induced Anti-Drug Antibody (ADA) Against PF-06817024 in Part 1, 2, and 3 [Part 1 SD cohorts: baseline up to Day 780; Part 1 MD cohort: baseline up to Day 693; Part 2: baseline up to Day 692, Part 3: baseline up to Day 964.]
ADA was an immunogenicity endpoint. A participant had treatment-induced ADA when baseline titer was missing or negative and the participant had >=1 post-treatment positive titer.
- Number of Participants With Treatment-Induced Neutralizing Antibodies (NAbs) Against PF-06817024 in Part 1, 2, and 3 [Part 1 SD cohorts: baseline up to Day 780; Part 1 MD cohort: baseline up to Day 693; Part 2: baseline up to Day 692, Part 3: baseline up to Day 964.]
NAb was an immunogenicity endpoint. A participant had treatment-induced NAb when baseline titer was missing or negative and the participant had >=1 post-treatment positive titer.
Eligibility Criteria
Criteria
Inclusion Criteria
-
Healthy male subjects, healthy female subjects of non-childbearing potential, 18-55 years of age (Part 1)
-
Male subjects, female subjects of non-childbearing potential, female subjects of childbearing potential with documented bilateral tubal ligation (tubes tied) or bilateral salpingectomy (tubes removed), 18-65 years of age, and 2 of the following symptoms: nasal congestion/obstruction, nasal discharge, face pain/pressure,or reduction/loss of smell (Part 2)
-
Male or female subjects between the ages of 18 and 75 years, inclusive with moderate-to-severe Atopic Dermatitis, agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps, or other ultraviolet light sources during the study (Part 3)
Exclusion Criteria:
-
Clinically significant diseases (cardiac, psychiatric, autoimmune, renal, etc.), positive urine drug test, fever within 7 days of dosing, active infections within 28 days of dosing (Part 1 and 2 and 3)
-
History of allergic reaction to topical lidocaine, nasal surgery within 6 months (Part
- Exposure to live or attenuated vaccines, have skin conditions other than Atopic Dermatitis, use of JAK inhibitors and biologics (Part 3)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | UC Davis Dermatology | Sacramento | California | United States | 95816 |
2 | UC Davis CTSC Clinical Research Center | Sacramento | California | United States | 95817 |
3 | UC Davis Health | Sacramento | California | United States | 95817 |
4 | New Haven Clinical Research Unit | New Haven | Connecticut | United States | 06511 |
5 | Dermatology Physicians of Connecticut | Shelton | Connecticut | United States | 06484 |
6 | ForCare Clinical Research | Tampa | Florida | United States | 33613 |
7 | Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | United States | 46256 |
8 | Dawes Fretzin Dermatology Group, LLC | Indianapolis | Indiana | United States | 46256 |
9 | The Indiana Clinical Trials Center | Plainfield | Indiana | United States | 46168 |
10 | Academic Dermatology | Edina | Minnesota | United States | 55435 |
11 | Clinical Research Institute, Inc. | Minneapolis | Minnesota | United States | 55402 |
12 | Ear, Nose & Throat Specialty Care of Minnesota, P.A. | Minneapolis | Minnesota | United States | 55404 |
13 | Prism Research, LLC | Saint Paul | Minnesota | United States | 55114 |
14 | Hassman Research Institute | Berlin | New Jersey | United States | 08009 |
15 | Carolina Phase 1 Research, LLC | Raleigh | North Carolina | United States | 27612 |
16 | Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | United States | 74136 |
17 | Health Concepts | Rapid City | South Dakota | United States | 57702 |
18 | Lee Medical Associates, PA | San Antonio | Texas | United States | 78213 |
19 | Progressive Clinical Research, PA | San Antonio | Texas | United States | 78213 |
20 | Virginia Clinical Research, Inc. | Norfolk | Virginia | United States | 23502 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- C0341001
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | A total of 97 participants were assigned and treated in this study, with 49, 20, and 28 participants in Part 1, 2, and 3, respectively. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg Intravenously (IV) Single Dose (SD) | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg Subcutaneously (SC) SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV Multiple Doses (MD) | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD | Part 2 Cohort 8: PF-06817024 300 mg IV Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) | Part 2 Cohort 8: Placebo IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV Atopic Dermatitis (AD) | Part 3 Cohort 13: Placebo IV AD |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. | Participants with chronic rhinosinusitis with nasal polyps (CRSwNP) received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Period Title: Overall Study | ||||||||||||||
STARTED | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 | 11 | 9 | 20 | 8 |
COMPLETED | 5 | 6 | 6 | 2 | 4 | 6 | 5 | 8 | 2 | 2 | 10 | 6 | 5 | 1 |
NOT COMPLETED | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 3 | 15 | 7 |
Baseline Characteristics
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD | Total |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. | Total of all reporting groups |
Overall Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 | 11 | 9 | 20 | 8 | 97 |
Age (years) [Mean (Standard Deviation) ] | |||||||||||||||
Mean (Standard Deviation) [years] |
34.0
(4.9)
|
37.0
(10.7)
|
43.2
(8.7)
|
27.0
(6.1)
|
26.5
(6.8)
|
36.3
(7.7)
|
39.8
(8.7)
|
33.3
(12.0)
|
23.5
(0.7)
|
34.5
(4.9)
|
54.4
(6.2)
|
42.8
(10.7)
|
38.9
(13.8)
|
41.0
(17.4)
|
49.2
(10.2)
|
Sex: Female, Male (Count of Participants) | |||||||||||||||
Female |
0
0%
|
0
0%
|
2
33.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
3
27.3%
|
4
44.4%
|
12
60%
|
7
87.5%
|
29
29.9%
|
Male |
6
100%
|
6
100%
|
4
66.7%
|
3
100%
|
4
100%
|
6
100%
|
6
100%
|
7
87.5%
|
2
100%
|
2
100%
|
8
72.7%
|
5
55.6%
|
8
40%
|
1
12.5%
|
68
70.1%
|
Race/Ethnicity, Customized (Count of Participants) | |||||||||||||||
White |
1
16.7%
|
3
50%
|
3
50%
|
1
33.3%
|
1
25%
|
1
16.7%
|
1
16.7%
|
3
37.5%
|
0
0%
|
1
50%
|
11
100%
|
7
77.8%
|
8
40%
|
3
37.5%
|
44
45.4%
|
Black |
4
66.7%
|
2
33.3%
|
2
33.3%
|
2
66.7%
|
1
25%
|
4
66.7%
|
3
50%
|
3
37.5%
|
2
100%
|
1
50%
|
0
0%
|
1
11.1%
|
9
45%
|
3
37.5%
|
37
38.1%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
1
11.1%
|
1
5%
|
0
0%
|
4
4.1%
|
Other |
1
16.7%
|
1
16.7%
|
1
16.7%
|
0
0%
|
2
50%
|
1
16.7%
|
1
16.7%
|
1
12.5%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
10%
|
2
25%
|
12
12.4%
|
Outcome Measures
Title | Number of Participants With All-causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part 1 |
---|---|
Description | An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. |
Time Frame | From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 3: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 |
Number of Participants With All-Causality TEAEs |
6
100%
|
4
66.7%
|
5
83.3%
|
3
100%
|
1
25%
|
6
100%
|
4
66.7%
|
8
100%
|
2
100%
|
2
100%
|
Number of Participants With All-Causality SAEs |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With Treatment-Related TEAEs and SAEs in Part 1 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator. |
Time Frame | From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 |
Number of Participants With Treatment-Related TEAEs |
2
33.3%
|
2
33.3%
|
2
33.3%
|
2
66.7%
|
1
25%
|
3
50%
|
1
16.7%
|
1
12.5%
|
0
0%
|
1
50%
|
Number of Participants With Treatment-Related SAEs |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of All-Causality TEAEs According to Severity in Part 1 |
---|---|
Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function. |
Time Frame | From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 |
Mild |
14
|
10
|
20
|
11
|
4
|
15
|
10
|
30
|
3
|
4
|
Moderate |
2
|
2
|
1
|
0
|
0
|
2
|
1
|
2
|
0
|
0
|
Severe |
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Title | Number of Participants With Permanent Discontinuation Due to TEAEs in Part 1 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. |
Time Frame | From Study Day 1 (baseline) up to Day 421 (Cohort 1 and 2), Day 601 (Cohort 3), Day 691 (Cohort 4), Day 781 (Cohort 5), and Day 511 (Cohort 7). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 |
Count of Participants [Participants] |
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Title | Number of Participants With All-Causality TEAEs and SAEs in Part 2 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. |
Time Frame | From Study Day 1 (baseline) up to Day 691. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP |
---|---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. |
Measure Participants | 11 | 9 |
Number of Participants With All-Causality TEAEs |
10
166.7%
|
8
133.3%
|
Number of Participants With All-Causality SAEs |
0
0%
|
1
16.7%
|
Title | Number of Participants With Treatment-Related TEAEs and SAEs in Part 2 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator. |
Time Frame | From Study Day 1 (baseline) up to Day 691. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP |
---|---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. |
Measure Participants | 11 | 9 |
Number of Participants With Treatment-Related TEAEs |
5
83.3%
|
3
50%
|
Number of Participants With Treatment-Related SAEs |
0
0%
|
0
0%
|
Title | Number of All-Causality TEAEs According to Severity in Part 2 |
---|---|
Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function. |
Time Frame | From Study Day 1 (baseline) up to Day 691. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP |
---|---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. |
Measure Participants | 11 | 9 |
Mild |
44
|
24
|
Moderate |
14
|
9
|
Severe |
0
|
3
|
Title | Number of Participants With Permanent Discontinuation Due to TEAEs in Part 2 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. |
Time Frame | From Study Day 1 (baseline) up to Day 691. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP |
---|---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. |
Measure Participants | 11 | 9 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Number of Participants With All-Causality TEAEs and SAEs in Part 3 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. |
Time Frame | From Study Day 1 (baseline) up to Day 1105. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD |
---|---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Measure Participants | 20 | 8 |
Number of Participants With All-Causality TEAEs |
12
200%
|
5
83.3%
|
Number of Participants With All-Causality SAEs |
3
50%
|
1
16.7%
|
Title | Number of Participants With Treatment-Related TEAEs and SAEs in Part 3 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly/birth defect. The causality of TEAEs and SAEs was determined by the investigator. |
Time Frame | From Study Day 1 (baseline) up to Day 1105. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD |
---|---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Measure Participants | 20 | 8 |
Number of Participants With Treatment-Related TEAEs |
5
83.3%
|
0
0%
|
Number of Participants With Treatment-Related SAEs |
1
16.7%
|
0
0%
|
Title | Number of All-Causality TEAEs According to Severity in Part 3 |
---|---|
Description | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. TEAE was assessed by the investigator according to severity; Mild: did not interfere with participant's usual function; moderate: interfered to some extent with participant's usual function; severe: interfered significantly with participant's usual function. |
Time Frame | From Study Day 1 (baseline) up to Day 1105. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD |
---|---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Measure Participants | 20 | 8 |
Mild |
12
|
2
|
Moderate |
15
|
5
|
Severe |
13
|
1
|
Title | Number of Participants With Permanent Discontinuation Due to TEAEs in Part 3 |
---|---|
Description | An AE was any untoward medical occurrence in a clinical investigation participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. |
Time Frame | From Study Day 1 (baseline) up to Day 1105. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD |
---|---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Measure Participants | 20 | 8 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
Title | Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 1 |
---|---|
Description | Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. |
Time Frame | Part 1 single-dose cohorts: from Study Day 1 (baseline) up to Day 211. Part 1 multiple-dose cohorts: from Study Day 1 (baseline) up to Day 241. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 |
Blood creatine phosphokinase increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
0
0%
|
Transaminases increased |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
0
0%
|
Title | Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 2 |
---|---|
Description | Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. |
Time Frame | Part 2: from Study Day 1 (baseline) up to Day 211. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP |
---|---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. |
Measure Participants | 11 | 9 |
Blood creatine phosphokinase increased |
0
0%
|
0
0%
|
Transaminases increased |
0
0%
|
0
0%
|
Title | Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis in Part 3 |
---|---|
Description | Hematology parameters included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry parameters included blood urea nitrogen, glucose (fasting), calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein. Urine parameters included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. |
Time Frame | Part 3: from Study Day 1 (baseline) up to Day 966. |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD |
---|---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Measure Participants | 20 | 8 |
Blood creatine phosphokinase increased |
0
0%
|
0
0%
|
Transaminases increased |
1
16.7%
|
0
0%
|
Title | Number of Participants With Vital Sign Abnormalities in Part 1 |
---|---|
Description | Criteria for abnormality in vital signs: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine diastolic blood pressure (DBP) <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg; supine systolic blood pressure (SBP) <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here. |
Time Frame | Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 |
Maximum Increase from Baseline in Supine SBP >= 30 mmHg |
1
16.7%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
0
0%
|
Maximum Increase from Baseline in Supine DBP >= 20 mmHg |
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
1
12.5%
|
0
0%
|
0
0%
|
Maximum Decrease from Baseline in Supine SBP >= 30 mmHg |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
0
0%
|
Maximum Decrease from Baseline in Supine DBP >= 20 mmHg |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
50%
|
1
50%
|
Supine SBP <90 mmHg |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
1
12.5%
|
0
0%
|
1
50%
|
Supine DBP <50 mmHg |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
12.5%
|
0
0%
|
1
50%
|
Title | Number of Participants With Vital Sign Abnormalities in Part 2 |
---|---|
Description | Criteria for abnormality in vital signs: supine pulse rate <40 bpm or >120 bpm; supine DBP <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg; supine SBP <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here. |
Time Frame | Study Day 1 (baseline) up to end of study (Study Day 211). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP |
---|---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. |
Measure Participants | 11 | 9 |
Maximum Increase from Baseline in Supine SBP >= 30 mmHg |
1
16.7%
|
0
0%
|
Maximum Decrease from Baseline in Supine SBP >= 30 mmHg |
2
33.3%
|
0
0%
|
Supine SBP <90 mmHg |
1
16.7%
|
0
0%
|
Title | Number of Participants With Vital Sign Abnormalities in Part 3 |
---|---|
Description | Criteria for abnormality in vital signs: supine pulse rate <40 bpm or >120 bpm; supine DBP <50 mmHg, maximum increase or decrease from baseline of >=20 mmHg; supine SBP <90 mmHg, maximum increase or decrease from baseline of >=30 mmHg. Baseline was defined as the last measurement prior to the first dosing. Vital sign abnormalities reported for at least 1 participant are presented here. |
Time Frame | Study Day 1 (baseline) up to end of study (Study Day 337). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD |
---|---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Measure Participants | 20 | 8 |
Maximum Increase from Baseline in Supine SBP >= 30 mmHg |
1
16.7%
|
0
0%
|
Maximum Increase from Baseline in Supine DBP >= 20 mmHg |
3
50%
|
0
0%
|
Maximum Decrease from Baseline in Supine DBP >= 20 mmHg |
2
33.3%
|
0
0%
|
Supine DBP <50 mmHg |
1
16.7%
|
0
0%
|
Title | Number of Participants With Electrocardiogram (ECG) Abnormalities in Part 1 |
---|---|
Description | ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450<= QTcF <480, 480<= QTcF <500, and QTcF >=500; QTcF maximum increase from baseline(msec): 30<= change <60, and change >=60; 2) maximum PR interval (msec): >=300; PR increase from baseline (msec): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (msec): >=140; QRS increase from baseline (msec) >=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here. |
Time Frame | Study Day 1 (baseline) up to end of study (Study Day 211 for Part 1 SD cohorts, and Study Day 241 for Part 1 MD cohorts). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD |
---|---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 8 | 2 | 2 |
450 <= maximum QTcF interval (msec) <480 |
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
0
0%
|
0
0%
|
30 <= maximum QTcF interval increase from baseline (msec) <60 |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2
25%
|
1
50%
|
0
0%
|
Title | Number of Participants With ECG Abnormalities in Part 2 |
---|---|
Description | ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450<= QTcF <480, 480<= QTcF <500, and QTcF >=500; QTcF maximum increase from baseline(msec): 30<= change <60, and change >=60; 2) maximum PR interval (msec): >=300; PR increase from baseline (msec): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (msec): >=140; QRS increase from baseline (msec) >=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here. |
Time Frame | Study Day 1 (baseline) up to end of study (Study Day 211). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP |
---|---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. |
Measure Participants | 11 | 9 |
450 <= maximum QTcF interval (msec) <480 |
1
16.7%
|
2
33.3%
|
30 <= maximum QTcF interval increase from baseline (msec) <60 |
1
16.7%
|
1
16.7%
|
Title | Number of Participants With ECG Abnormalities in Part 3 |
---|---|
Description | ECG abnormalities criteria included: 1) maximum QTc interval adjusted according Fridericia formula (QTcF) (msec): 450<= QTcF <480, 480<= QTcF <500, and QTcF >=500; QTcF maximum increase from baseline(msec): 30<= change <60, and change >=60; 2) maximum PR interval (msec): >=300; PR increase from baseline (msec): baseline >200 with 25% increase at maximum, baseline <=200 with 50% increase at maximum; 3) maximum QRS (msec): >=140; QRS increase from baseline (msec) >=50%. Baseline was defined as the average of the last triplicate measurement prior to the first dosing. ECG abnormalities reported for at least 1 participant are presented here. |
Time Frame | Study Day 1 (baseline) up to end of study (Study Day 337). |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study medication. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD |
---|---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. |
Measure Participants | 20 | 8 |
450 <= maximum QTcF interval (msec) <480 |
2
33.3%
|
2
33.3%
|
30 <= maximum QTcF interval increase from baseline (msec) <60 |
5
83.3%
|
2
33.3%
|
Maximum QTcF interval increase from baseline (msec) >=60 |
1
16.7%
|
0
0%
|
Maximum QTcF interval (msec) >=500 |
0
0%
|
1
16.7%
|
Title | Maximum Observed Serum Concentration (Cmax) of PF-06817024 Following Single Dose in Part 1 |
---|---|
Description | Maximum observed serum concentration (Cmax) of PF-06817024 following single dose in Part 1; Cmax was defined as the maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD |
---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 6 | 3 | 6 | 6 |
Geometric Mean (Geometric Coefficient of Variation) [ug/mL] |
2.879
(19)
|
12.26
(20)
|
2.471
(43)
|
35.56
(11)
|
97.49
(7)
|
313.2
(17)
|
Title | Cmax of PF-06817024 Following Multiple Doses in Part 1 |
---|---|
Description | Cmax was defined as the maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 1 |
35.35
(15)
|
Day 31 |
NA
(NA)
|
Day 46 |
41.32
(11)
|
Title | Cmax of PF-06817024 in Part 2 |
---|---|
Description | Cmax was defined as the maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 11 |
Geometric Mean (Geometric Coefficient of Variation) [ug/mL] |
107.1
(15)
|
Title | Cmax of PF-06817024 in Part 3 |
---|---|
Description | Cmax was defined as the maximum observed serum concentration. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 20 |
Day 1 |
197.3
(36)
|
Day 29 |
165.9
(36)
|
Day 57 |
190.7
(39)
|
Day 85 |
199.8
(37)
|
Title | Dose Normalized Maximum Observed Serum Concentration (Cmax[dn]) of PF-06817024 Following Single Dose in Part 1 |
---|---|
Description | Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD |
---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 6 | 3 | 6 | 6 |
Geometric Mean (Geometric Coefficient of Variation) [ug/mL/mg] |
0.2879
(19)
|
0.4091
(20)
|
0.08230
(43)
|
0.3556
(11)
|
0.3249
(7)
|
0.3132
(17)
|
Title | Cmax(dn) of PF-06817024 Following Multiple Doses in Part 1 |
---|---|
Description | Cmax(dn) was defined as dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 1 |
0.3535
(15)
|
Day 31 |
NA
(NA)
|
Day 46 |
0.4132
(11)
|
Title | Cmax(dn) of PF-06817024 in Part 2 |
---|---|
Description | Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 11 |
Geometric Mean (Geometric Coefficient of Variation) [ug/mL/mg] |
0.3569
(15)
|
Title | Cmax(dn) of PF-06817024 in Part 3 |
---|---|
Description | Cmax(dn) was defined as the dose normalized maximum observed serum concentration, and calculated by Cmax/Dose. Cmax was defined as the maximum observed serum concentration. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 20 |
Day 1 |
0.3306
(36)
|
Day 29 |
0.5544
(36)
|
Day 57 |
0.6361
(39)
|
Day 85 |
0.6663
(37)
|
Title | Time to Reach Maximum Observed Serum Concentration (Tmax) of PF-06817024 Following Single Dose in Part 1 |
---|---|
Description | Time to reach maximum observed serum concentration (Tmax) of PF-06817024 in Part 1; Tmax was defined as time to reach maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD |
---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 6 | 3 | 6 | 6 |
Median (Full Range) [Hours] |
4.00
|
1.76
|
338
|
1.07
|
2.00
|
1.775
|
Title | Tmax of PF-06817024 Following Multiple Doses in Part 1 |
---|---|
Description | Tmax was defined as time to reach maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 1 |
2.010
|
Day 31 |
NA
|
Day 46 |
1.550
|
Title | Tmax of PF-06817024 in Part 2 |
---|---|
Description | Tmax was defined as time to reach maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 11 |
Median (Full Range) [Hours] |
2.00
|
Title | Tmax of PF-06817024 in Part 3 |
---|---|
Description | Tmax was defined as time to reach maximum observed serum concentration. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 20 |
Day 1 |
2.03
|
Day 29 |
1.70
|
Day 57 |
1.75
|
Day 85 |
1.76
|
Title | Area Under the Curve From Time Zero to Infinity Concentration (AUCinf) of PF-06817024 Following Single Dose in Part 1 and 2 |
---|---|
Description | Area under the curve from time zero to infinity concentration (AUCinf) of PF-06817024 following single dose in Part 1 and 2; AUCinf was defined as area under the curve from time zero to infinity concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 6 | 3 | 6 | 5 | 11 |
Geometric Mean (Geometric Coefficient of Variation) [ug*hr/mL] |
4384
(28)
|
14640
(28)
|
8646
(38)
|
44460
(22)
|
116700
(23)
|
427100
(10)
|
146200
(19)
|
Title | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06817024 Following Single Dose in Part 1 and 2 |
---|---|
Description | Area under the curve from time zero to last quantifiable concentration (AUClast) of PF-06817024 following single dose in Part 1 and 2; AUClast was defined as area under the curve from time zero to last quantifiable concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 6 | 3 | 6 | 5 | 11 |
Geometric Mean (Geometric Coefficient of Variation) [ug*hr/mL] |
4075
(29)
|
14070
(26)
|
8333
(39)
|
43510
(22)
|
116000
(22)
|
425700
(10)
|
143300
(23)
|
Title | Area Under the Curve Within Dosing Interval (AUCtau) of PF-06817024 Following Multiple Doses in Part 1 |
---|---|
Description | Area under the curve within dosing interval (AUCtau) of PF-06817024 following multiple doses in Part 1; AUCtau was defined as area under the curve within dosing interval. The dosing interval was 720 hours. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 1 |
10580
(11)
|
Day 31 |
NA
(NA)
|
Day 46 |
16210
(15)
|
Title | AUCtau of PF-06817024 in Part 3 |
---|---|
Description | AUCtau was defined as area under the curve within dosing interval. The dosing interval was 672 hours. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 20 |
Day 1 |
58350
(31)
|
Day 29 |
77550
(38)
|
Day 57 |
90340
(42)
|
Day 85 |
92230
(42)
|
Title | Dose Normalized Area Under the Curve Within Dosing Interval (AUCtau[dn]) of PF-06817024 Following Multiple Doses in Part 1 |
---|---|
Description | Dose normalized area under the curve within dosing interval (AUCtau[dn]) of PF-06817024 following multiple doses in Part 1; AUCtau(dn) was defined as dose normalized area under the curve within dosing interval. The dosing interval was 720 hours. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 1 |
105.8
(11)
|
Day 31 |
NA
(NA)
|
Day 46 |
162.1
(15)
|
Title | AUCtau(dn) of PF-06817024 Following Multiple Doses in Part 3 |
---|---|
Description | AUCtau(dn) was defined as dose normalized area under the curve within dosing interval. The dosing interval was 672 hours. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 20 |
Day 1 |
97.98
(30)
|
Day 29 |
259.1
(38)
|
Day 57 |
301.1
(42)
|
Day 85 |
307.3
(42)
|
Title | Average Concentration Over Dosing Interval (Cav) of PF-06817024 Following Multiple Doses in Part 1 |
---|---|
Description | Average concentration over dosing interval (Cav) of PF-06817024 following multiple doses in Part 1; Cav was defined as average concentration over dosing interval. The dosing interval was 720 hours. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 1 |
14.70
(12)
|
Day 31 |
NA
(NA)
|
Day 46 |
22.55
(16)
|
Title | Cav of PF-06817024 Following Multiple Doses in Part 3 |
---|---|
Description | Cav was defined as average concentration over dosing interval. The dosing interval was 672 hours. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 20 |
Day 1 |
86.78
(30)
|
Day 29 |
115.4
(38)
|
Day 57 |
134.4
(42)
|
Day 85 |
137.2
(42)
|
Title | Terminal Elimination Half Life (t1/2) of PF-06817024 Following Single Dose in Part 1 |
---|---|
Description | t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD |
---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 6 | 3 | 6 | 5 |
Mean (Standard Deviation) [Days] |
91.34
(14.499)
|
88.88
(15.358)
|
97.17
(11.189)
|
83.70
(32.608)
|
83.33
(20.016)
|
93.90
(5.4749)
|
Title | t1/2 of PF-06817024 Following Multiple Doses in Part 1 |
---|---|
Description | T1/2 of PF-06817024 following multiple doses in Part 1; t1/2 was defined as terminal elimination half life. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 31 |
NA
(NA)
|
Day 46 |
98.87
(5.6083)
|
Title | t1/2 of PF-06817024 in Part 2 |
---|---|
Description | t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to a maximum of 690 days/16560 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|
Arm/Group Description | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 11 |
Mean (Standard Deviation) [Days] |
85.68
(11.447)
|
Title | t1/2 of PF-06817024 in Part 3 |
---|---|
Description | t1/2 was defined as terminal elimination half life, and was calculated by Loge(2)/kel, where kel was the terminal elimination phase rate constant calculated by a linear regression of the log-linear concentration-time curve. For Part 3 Cohort 13: PF-06817024 600 mg + 300 mg IV AD, t1/2 of the last dose on Day 85 was reported in the table. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 12 |
Mean (Standard Deviation) [Days] |
75.98
(15.996)
|
Title | Apparent Volume of Distribution (Vz/F) of PF-06817024 for the Subcutaneous Cohort in Part 1 |
---|---|
Description | Apparent volume of distribution (Vz/F) of PF-06817024 for the subcutaneous cohort in Part 1; Vz/F was defined as apparent volume of distribution. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 7: PF-06817024 30 mg SC SD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. |
Measure Participants | 6 |
Geometric Mean (Geometric Coefficient of Variation) [L] |
11.60
(37)
|
Title | Apparent Clearance (CL/F) of PF-06817024 for the Subcutaneous Cohort in Part 1 |
---|---|
Description | Apparent clearance (CL/F) of PF-06817024 for the subcutaneous cohort in Part 1; CL/F was defined as apparent clearance. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96 hours post dose on Day 1, and on Follow-up Days 8, 15, 32, 46, 61, 91, 121, 151, 181, 211, and at Extended Follow-Up visits (up to a maximum of 780 days/18720 hours post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 7: PF-06817024 30 mg SC SD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. |
Measure Participants | 6 |
Geometric Mean (Geometric Coefficient of Variation) [L/hr] |
0.003470
(38)
|
Title | Volume of Distribution at Steady State (Vss) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2 |
---|---|
Description | Volume of distribution at steady state (Vss) of PF-06817024 following a single dose in Part 1 and Part 2; Vss was defined as volume of distribution at steady state. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, and 96 hour post dose on Day 1, and Days 8, 15, 32, 61, 91, 121, 181, 211, and at Extended Follow-Up visits (up to 780 days for Part 1 and 690 days for Part 2). For Part 1 only: at post-dose 48 and 72 hour, Days 46 and 151. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 3 | 6 | 5 | 11 |
Geometric Mean (Geometric Coefficient of Variation) [L] |
6.949
(15)
|
5.929
(22)
|
6.449
(19)
|
6.863
(16)
|
7.260
(12)
|
6.250
(17)
|
Title | Clearance (CL) of PF-06817024 Following Single Intravenous Dose in Part 1 and Part 2 |
---|---|
Description | CL was defined as Clearance, calculated by Dose/AUCinf. AUCinf was defined as area under the curve from time zero to infinity concentration. |
Time Frame | On Day 1 at pre-dose, post-dose 1, 2, 4, 8, 12, 24, 96 hour, Day 8, 15, 32, 61, 91, 121,181, 211, 241, 331, and 421. For Part 1 only: at post-dose 48 and 72 hour, Day 46 and 151. For Part 2 only: on Day 511, 601, and 691. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP |
---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. |
Measure Participants | 5 | 6 | 3 | 6 | 5 | 11 |
Geometric Mean (Geometric Coefficient of Variation) [L/hr] |
0.00228
(28)
|
0.00205
(28)
|
0.002249
(22)
|
0.002574
(23)
|
0.002341
(10)
|
0.002053
(19)
|
Title | Trough Serum Concentration (Cmin) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 |
---|---|
Description | Trough serum concentration (Cmin) of PF-06817024 post second dose following multiple doses in Part 1; Cmin was defined as the trough serum concentration. |
Time Frame | At pre-dose on Day 31 or Day 46. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 31 |
NA
(NA)
|
Day 46 |
9.851
(20)
|
Title | Cmin of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 |
---|---|
Description | Cmin of PF-06817024 post last dose following multiple doses in Part 3; Cmin was defined as the trough serum concentration. |
Time Frame | At pre dose (0 hour) on Day 85. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 15 |
Geometric Mean (Geometric Coefficient of Variation) [ug/mL] |
81.1
(51)
|
Title | Accumulation Ratio for Cmax (Rac, Cmax) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 |
---|---|
Description | Rac, Cmax was defined as accumulation ratio for Cmax, and was calculated by (Cmax on Day 31 or Day 46) / Cmax on Day 1. Cmax was defined as the maximum observed serum concentration. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 31 |
NA
(NA)
|
Day 46 |
1.106
(3)
|
Title | Rac, Cmax of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 |
---|---|
Description | Rac, Cmax was defined as accumulation ratio for Cmax, and was calculated by (Cmax on Day 85) / (Cmax on Day 1). Cmax was defined as the maximum observed serum concentration. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 16 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio] |
2.005
(24)
|
Title | Accumulation Ratio for AUCtau (Rac) of PF-06817024 Post Second Dose Following Multiple Doses in Part 1 |
---|---|
Description | Rac was defined as accumulation ratio for AUCtau. AUCtau was defined as area under the curve within dosing interval. The dosing interval was 720 hours. |
Time Frame | Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, and 96 hr post dose on Day 1, Days 8 and 15, Day 31/46 (at pre-dose, 1, 2, 4, 8, 12, 24, 48 hr), Days 61, 91, 121, 151, 181, 211, 241, at Extended Follow-Up visits (up to a maximum of 645 days/15480 hr post dose). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 1 Cohort 3: PF-06817024 100 mg IV MD |
---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). |
Measure Participants | 4 |
Day 31 |
NA
(NA)
|
Day 46 |
1.499
(10)
|
Title | Rac of PF-06817024 Post Last Dose Following Multiple Doses in Part 3 |
---|---|
Description | Rac was defined as accumulation ratio for AUCtau. AUCtau was defined as area under the curve within dosing interval. The dosing interval was 672 hours. |
Time Frame | On Day 1 (at pre-dose, 1.5, 4, and 168 hours post dose), and Days 29, 57, and 85 (at pre-dose, 1.5 and 4 hours post dose), and on Days 113, 253, 337, and Extended Follow-Up visits (up to a maximum of 882 days/21168 hours post dose on Day 85). |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants treated who had at least 1 of the PK parameters of interest measured. |
Arm/Group Title | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|
Arm/Group Description | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 15 |
Geometric Mean (Geometric Coefficient of Variation) [Ratio] |
3.163
(20)
|
Title | Number of Participants With Treatment-Induced Anti-Drug Antibody (ADA) Against PF-06817024 in Part 1, 2, and 3 |
---|---|
Description | ADA was an immunogenicity endpoint. A participant had treatment-induced ADA when baseline titer was missing or negative and the participant had >=1 post-treatment positive titer. |
Time Frame | Part 1 SD cohorts: baseline up to Day 780; Part 1 MD cohort: baseline up to Day 693; Part 2: baseline up to Day 692, Part 3: baseline up to Day 964. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants who received at least 1 dose of investigational product and had at least 1 post-treatment measurement of immunogenicity parameters of interest. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 11 | 20 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
2
50%
|
0
0%
|
1
16.7%
|
1
12.5%
|
1
50%
|
Title | Number of Participants With Treatment-Induced Neutralizing Antibodies (NAbs) Against PF-06817024 in Part 1, 2, and 3 |
---|---|
Description | NAb was an immunogenicity endpoint. A participant had treatment-induced NAb when baseline titer was missing or negative and the participant had >=1 post-treatment positive titer. |
Time Frame | Part 1 SD cohorts: baseline up to Day 780; Part 1 MD cohort: baseline up to Day 693; Part 2: baseline up to Day 692, Part 3: baseline up to Day 964. |
Outcome Measure Data
Analysis Population Description |
---|
All enrolled participants who received at least 1 dose of investigational product and had at least 1 post-treatment measurement of immunogenicity parameters of interest. |
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD |
---|---|---|---|---|---|---|---|---|---|
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. |
Measure Participants | 6 | 6 | 6 | 3 | 4 | 6 | 6 | 11 | 20 |
Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
Adverse Events
Time Frame | From Study Day 1 (baseline) up to Day 421 (Part 1 Cohort 1 and 2), Day 601 (Part 1 Cohort 3), Day 691 (Part 1 Cohort 4), Day 781 (Part 1 Cohort 5), and Day 511 (Part 1 Cohort 7), Day 691 (Part 2 Cohort 8), Day 1105 (Part 3 Cohort 13). | |||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs. | |||||||||||||||||||||||||||
Arm/Group Title | Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD | ||||||||||||||
Arm/Group Description | Healthy participants who might be mildly atopic received PF-06817024 10 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 30 mg SC for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 100 mg IV for MD (2 doses, on Study Days 1 and 31/46). | Healthy participants who might be mildly atopic received PF-06817024 300 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received PF-06817024 1000 mg IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 IV for MD (2 doses, on Study Days 1 and 46/47). | Healthy participants who might be mildly atopic received the matching placebo of PF-06817024 SC for a SD on Study Day 1. | Participants with CRSwNP received PF-06817024 300 mg IV for a SD on Study Day 1. | Participants with CRSwNP received the matching placebo of PF-06817024 IV for a SD on Study Day 1. | Participants with moderate to severe AD received PF-06817024 600 mg loading dose IV on Study Day 1 followed by 3 doses of PF-06817024 300 mg IV on Study Days 29, 57, and 85. | Participants with moderate to severe AD received the matching placebo of PF-06817024 IV on Study Days 1, 29, 57, and 85. | ||||||||||||||
All Cause Mortality |
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Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD | |||||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Serious Adverse Events |
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Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD | |||||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 3/20 (15%) | 1/8 (12.5%) | ||||||||||||||
Blood and lymphatic system disorders | ||||||||||||||||||||||||||||
Iron deficiency anaemia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 1/20 (5%) | 0/8 (0%) | ||||||||||||||
Infections and infestations | ||||||||||||||||||||||||||||
Upper respiratory tract infection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Eczema impetiginous | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 1/8 (12.5%) | ||||||||||||||
Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||
Lower limb fracture | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 1/20 (5%) | 0/8 (0%) | ||||||||||||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||
Adenosquamous carcinoma of the cervix | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 1/20 (5%) | 0/8 (0%) | ||||||||||||||
Pregnancy, puerperium and perinatal conditions | ||||||||||||||||||||||||||||
Premature labour | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 1/20 (5%) | 0/8 (0%) | ||||||||||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||
Asthma | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Other (Not Including Serious) Adverse Events |
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Part 1 Cohort 1: PF-06817024 10 mg IV SD | Part 1 Cohort 2: PF-06817024 30 mg IV SD | Part 1 Cohort 7: PF-06817024 30 mg SC SD | Part 1 Cohort 3: PF-06817024 100 mg IV SD | Part 1 Cohort 3: PF-06817024 100 mg IV MD | Part 1 Cohort 4: PF-06817024 300 mg IV SD | Part 1 Cohort 5: PF-06817024 1000 mg IV SD | Part 1: Placebo IV SD | Part 1 Cohort 3: Placebo IV MD | Part 1 Cohort 7: Placebo SC SD | Part 2 Cohort 8: PF-06817024 300 mg IV CRSwNP | Part 2 Cohort 8: Placebo IV CRSwNP | Part 3 Cohort 13: PF-06817024 600 mg => 300 mg IV AD | Part 3 Cohort 13: Placebo IV AD | |||||||||||||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/6 (100%) | 4/6 (66.7%) | 5/6 (83.3%) | 3/3 (100%) | 1/4 (25%) | 6/6 (100%) | 4/6 (66.7%) | 8/8 (100%) | 2/2 (100%) | 2/2 (100%) | 10/11 (90.9%) | 8/9 (88.9%) | 8/20 (40%) | 5/8 (62.5%) | ||||||||||||||
Blood and lymphatic system disorders | ||||||||||||||||||||||||||||
Anaemia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Lymphadenopathy | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Cardiac disorders | ||||||||||||||||||||||||||||
Palpitations | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Ear and labyrinth disorders | ||||||||||||||||||||||||||||
Ear discomfort | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Vertigo | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Vertigo positional | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Eye disorders | ||||||||||||||||||||||||||||
Conjunctival hyperaemia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Eye pruritus | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Lacrimation increased | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Retinal detachment | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Gastrointestinal disorders | ||||||||||||||||||||||||||||
Toothache | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Abdominal distension | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dry mouth | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Gastrooesophageal reflux disease | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Mouth swelling | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Abdominal hernia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Abdominal pain upper | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 2/8 (25%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Constipation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dental caries | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Diarrhoea | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dyspepsia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Food poisoning | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 3/8 (37.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Haematochezia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Nausea | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 2/20 (10%) | 0/8 (0%) | ||||||||||||||
General disorders | ||||||||||||||||||||||||||||
Fatigue | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Application site irritation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Influenza like illness | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Infusion site haemorrhage | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 2/11 (18.2%) | 2/9 (22.2%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Therapeutic response increased | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 3/11 (27.3%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Vessel puncture site haemorrhage | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 4/11 (36.4%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Chest pain | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Infusion site pain | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Infusion site reaction | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Pyrexia | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Conditional aggravated | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 1/8 (12.5%) | ||||||||||||||
Peripheral swelling | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 1/8 (12.5%) | ||||||||||||||
Immune system disorders | ||||||||||||||||||||||||||||
Drug hypersensitivity | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Infections and infestations | ||||||||||||||||||||||||||||
Sinusitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 3/11 (27.3%) | 4/9 (44.4%) | 1/20 (5%) | 1/8 (12.5%) | ||||||||||||||
Pneumonia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 1/2 (50%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Upper respiratory tract infection | 3/6 (50%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 1/4 (25%) | 3/6 (50%) | 2/6 (33.3%) | 3/8 (37.5%) | 0/2 (0%) | 0/2 (0%) | 3/11 (27.3%) | 2/9 (22.2%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Bronchitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Chronic sinusitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Gastroenteritis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Influenza | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Viral upper respiratory tract infection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Abscess limb | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Bacteriuria | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Folliculitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 1/8 (12.5%) | ||||||||||||||
Fungal skin infection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Herpes zoster | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Hordeolum | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Oral herpes | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 1/4 (25%) | 0/6 (0%) | 2/6 (33.3%) | 0/8 (0%) | 0/2 (0%) | 1/2 (50%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Pharyngitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Rhinitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Viral infection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Injury, poisoning and procedural complications | ||||||||||||||||||||||||||||
Animal scratch | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Post procedural constipation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Procedural pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 2/11 (18.2%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Tooth fracture | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Contusion | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 1/8 (12.5%) | ||||||||||||||
Dental restoration failure | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Fall | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Joint injury | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Ligament sprain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Muscle strain | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Road traffic accident | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 1/2 (50%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Skin abrasion | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Skin laceration | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Tendon rupture | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Wrist fracture | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 2/20 (10%) | 0/8 (0%) | ||||||||||||||
Investigations | ||||||||||||||||||||||||||||
Blood creatine phosphokinase increased | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/2 (50%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Transaminases increased | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/2 (50%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Metabolism and nutrition disorders | ||||||||||||||||||||||||||||
Decreased appetite | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||||||
Arthralgia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Back pain | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 2/8 (25%) | 0/2 (0%) | 0/2 (0%) | 2/11 (18.2%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Muscle spasms | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Pain in extremity | 1/6 (16.7%) | 0/6 (0%) | 2/6 (33.3%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Arthritis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Intervertebral disc protrusion | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Plantar fasciitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Tendonitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||||||||||||||
Melanocytic naevus | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Nervous system disorders | ||||||||||||||||||||||||||||
Dizziness | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Headache | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) | 1/3 (33.3%) | 0/4 (0%) | 3/6 (50%) | 1/6 (16.7%) | 2/8 (25%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Anosmia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Hypogeusia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Hyposmia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Paraesthesia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Parosmia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Presyncope | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Sinus headache | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Burning sensation | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dysgeusia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Hypoaesthesia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Migraine | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Psychiatric disorders | ||||||||||||||||||||||||||||
Anxiety | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Sleep disorder due to general medical condition, insomnia type | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Depression | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Insomnia | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 1/4 (25%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Libido increased | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Nervousness | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Restlessness | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Renal and urinary disorders | ||||||||||||||||||||||||||||
Nephrolithiasis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Reproductive system and breast disorders | ||||||||||||||||||||||||||||
Benign prostatic hyperplasia | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||||||
Cough | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 2/11 (18.2%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Nasal congestion | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/3 (33.3%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 2/8 (25%) | 0/2 (0%) | 0/2 (0%) | 3/11 (27.3%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Asthma | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dysphonia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dyspnoea exertional | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Nasal discomfort | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Rhinorrhoea | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Sinus congestion | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 1/11 (9.1%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Rhinitis allergic | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/2 (50%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Oropharyngeal pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 2/8 (25%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||||||
Ecchymosis | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Skin irritation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Acne | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dermatitis | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Dermatitis atopic | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 3/20 (15%) | 0/8 (0%) | ||||||||||||||
Dermatitis contact | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 1/2 (50%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Eczema | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 2/20 (10%) | 0/8 (0%) | ||||||||||||||
Erythema | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 1/8 (12.5%) | ||||||||||||||
Miliaria | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Pityriasis rosea | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Rosacea | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Pruritus | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 1/8 (12.5%) | ||||||||||||||
Surgical and medical procedures | ||||||||||||||||||||||||||||
Cataract operation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 1/9 (11.1%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Vascular disorders | ||||||||||||||||||||||||||||
Flushing | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) | ||||||||||||||
Thrombophlebitis | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/3 (0%) | 0/4 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/2 (0%) | 0/2 (0%) | 0/11 (0%) | 0/9 (0%) | 0/20 (0%) | 0/8 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title | Pfizer ClinicalTrials.gov Call Center |
---|---|
Organization | Pfizer Inc. |
Phone | 1-800-718-1021 |
ClinicalTrials.gov_Inquiries@pfizer.com |
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