Study Of PF-06817024 In Healthy Subjects, In Patients With Chronic Rhinosinusitis With Nasal Polyps And in Patients With Atopic Dermatitis

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02743871
Collaborator
(none)
97
20
13
58.4
4.9
0.1

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
  • Biological: PF-06817024
  • Other: Placebo for PF-06817024
  • Biological: PF-06817024
  • Other: Placebo for PF-06817024
  • Biological: PF-06817024
  • Other: Placebo for PF-06817024
  • Biological: PF-06817024
  • Other: Placebo for PF-06817024
  • Biological: PF-06817024
  • Other: Placebo for PF-06817024
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

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF SINGLE AND/OR MULTIPLE INTRAVENOUS AND/OR SUBCUTANEOUS DOSES OF PF-06817024 IN HEALTHY SUBJECTS WHO MAY BE MILDLY ATOPIC, SUBJECTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPS, AND SUBJECTS WITH MODERATE-SEVERE ATOPIC DERMATITIS
Actual Study Start Date :
Apr 27, 2016
Actual Primary Completion Date :
Mar 9, 2021
Actual Study Completion Date :
Mar 9, 2021

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02743871
Other Study ID Numbers:
  • C0341001
First Posted:
Apr 19, 2016
Last Update Posted:
May 19, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms:

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

1. Primary Outcome
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%
2. Primary Outcome
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%
3. Primary Outcome
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
4. Primary Outcome
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%
5. Primary Outcome
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%
6. Primary Outcome
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%
7. Primary Outcome
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
8. Primary Outcome
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%
9. Primary Outcome
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%
10. Primary Outcome
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%
11. Primary Outcome
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
12. Primary Outcome
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%
13. Primary Outcome
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%
14. Primary Outcome
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%
15. Primary Outcome
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%
16. Primary Outcome
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%
17. Primary Outcome
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%
18. Primary Outcome
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%
19. Primary Outcome
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%
20. Primary Outcome
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%
21. Primary Outcome
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%
22. Secondary Outcome
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)
23. Secondary Outcome
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)
24. Secondary Outcome
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)
25. Secondary Outcome
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)
26. Secondary Outcome
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)
27. Secondary Outcome
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)
28. Secondary Outcome
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)
29. Secondary Outcome
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)
30. Secondary Outcome
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
31. Secondary Outcome
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
32. Secondary Outcome
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
33. Secondary Outcome
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
34. Secondary Outcome
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)
35. Secondary Outcome
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)
36. Secondary Outcome
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)
37. Secondary Outcome
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)
38. Secondary Outcome
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)
39. Secondary Outcome
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)
40. Secondary Outcome
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)
41. Secondary Outcome
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)
42. Secondary Outcome
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)
43. Secondary Outcome
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)
44. Secondary Outcome
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)
45. Secondary Outcome
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)
46. Secondary Outcome
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)
47. Secondary Outcome
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)
48. Secondary Outcome
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)
49. Secondary Outcome
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)
50. Secondary Outcome
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)
51. Secondary Outcome
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)
52. Secondary Outcome
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)
53. Secondary Outcome
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)
54. Secondary Outcome
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)
55. Secondary Outcome
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)
56. Secondary Outcome
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%
57. Secondary Outcome
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
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
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
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

[Not Specified]

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
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT02743871
Other Study ID Numbers:
  • C0341001
First Posted:
Apr 19, 2016
Last Update Posted:
May 19, 2022
Last Verified:
Feb 1, 2022