A Phase 2a Study to Assess Safety, Daily Symptoms, Pharmacokinetics (PK), and Biomarkers of YPL-001 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Details
Study Description
Brief Summary
This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment A Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) are administered approximately every 12 hours under fasting conditions for 55 consecutive days. |
Drug: YPL-001 80 mg
twice daily [BID]
|
| Experimental: Treatment B Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) are administered approximately every 12 hours under fasting conditions for 55 consecutive days. |
Drug: YPL-001 160 mg
twice daily [BID]
|
| Placebo Comparator: Treatment C Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. |
Drug: Placebo
twice daily [BID]
|
Outcome Measures
Primary Outcome Measures
- Treatment-Emergent Adverse Event Frequency by Treatment - Number of Patients Reporting Events [Up to Day 56]
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
- Treatment-Emergent Adverse Event Frequency by Treatment - Adverse Events [Up to Day 56]
A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings.
- Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Number of Patients Reporting Events [Up to Day 56]
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
- Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Adverse Events [Up to Day 56]
When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity.
Secondary Outcome Measures
- Change From Baseline in Main Peak Expiratory Flow (PEF) Measured Daily [Baseline to Day 55]
The PEF assessments are made daily prior to each dose from Day 1 of the Run-in Period to Day 56 of the Treatment Period. Three measurements were made at each time point using a hand held PEF meter. Readings not performed in the clinical research unit (CRU) were recorded in the patient e-diary. All PEF assessments were performed before administration of a bronchodilator where possible. Baseline is Day 1 predose measurement.
- Change From Baseline of Symptom Severity Score for Symptoms of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation [Baseline to Day 55]
Patient is asked to record the major (sputum quality, color, consistency) and minor (cough, wheeze, sore throat, nasal congestion, discharge, and body temperature above 100°F) symptoms of COPD exacerbation via the e-diary before each dosing. Baseline is Day 1 predose measurement Breathlessness(Dyspnea) Screen: 0(None)-10(Extreme): 0: better condition, 10: worse condition Sputum Quantity Screen: None(better)-greater than 1/4 cup(worse) Sputum Color Screen: White(better)-Brown(condition) Sputum Consistency Screen: Watery(better)-Thick(worse) Peak Flow Measurement Screen: 60(better)-800(worse) Symptoms Screen: (Temperature over 100F / Cough/Wheeze/Sore Throat/ Nasal Congestion) Nasal Discharge Screen(Yes/No) * quantitative data were summarized including sample size, arithmetic mean, standard deviation, CV, min and max. Symptom score catecorizes normal(0-0.5), mild(1-1.5), moderate(2-2.5), severe(3-3.5)
- Change From Baseline in Dyspnea (Modified Borg Dyspnea Scale) [Baseline to Day 55]
Severity level of patient's dyspnea is accessed via the modified Borg dyspnea scale programmed within the e-diary. The modified Borg dyspnea scale is a self-administered categorical scale with a score from 0 to 10, where 0 (as a measure of dyspnea) corresponds to the sensation of normal breathing (absence of dyspnea) and 10 corresponds to the patient's maximum possible sensation of dyspnea.
- Change From Baseline of Calculated Score From Duke Activity Status Index (DASI) [Baseline to Day 55]
Patient's functional capacity and activity status were accessed via the DASI programmed within the e-diary. DASI is a self-administered 12-item questionnaire that assesses daily activities such as personal care, ambulation, household tasks, sexual function and recreation with respective metabolic costs. Each item has a specific weight based on the metabolic cost. The final score ranges between 0 and 58.2 points. The higher score shows the better the functional capacity.
Other Outcome Measures
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [Baseline (Screen) to Day 55]
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FEV1 indicates improvement in lung function.
- Change From Baseline in Inspiratory Capacity (IC) [Baseline (Screening) to Day 55]
Inspiratory capacity (IC) is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. IC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation.
- Change From Baseline in Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC) Ratio [Baseline to Day 55]
The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC).
- Transition Dyspnea Index (TDI) Focal Score [Baseline to Day 55]
Dyspnea at baseline (Day -1) will be assessed with the Baseline Dyspnea Index (BDI). This instrument has 3 domains (functional impairment, magnitude of task and magnitude of effort) with the values added for a combined focal score. Functional impairment determines the impact of breathlessness on the ability to carry out activities; magnitude of task determines the type of task that causes breathlessness, magnitude of effort establishes the level of effort that results in breathlessness. The BDI scores range from 0 (very severe impairment) to 4 (no impairment) for each domain with the baseline focal score consisting of the sum of each domain (0 to 12). Dyspnea throughout the study will be performed at the time points. The change from baseline is measured by the Transition Dyspnea Index (TDI) score which ranges from -3 (major deterioration) to +3 (major improvement) for each domain with the TDI focal score consisting in the sum of each domain (-9 to +9).
- Change From Baseline in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) [Baseline to Day 55]
The chronic obstructive pulmonary disease assessment test (CAT) is a short and simple questionnaire of 8 items completed by patients to be performed at the time points. Scores for each of the 8 items are summed to give a single, final score ranging from 0 (no impact on daily activities) to 40 (very high impact on daily activity).
- Change in Percentage of Total Cells in Bronchoalveolar Lavage (BAL) [Baseline (Day -1) and Day 55]
The bronchoalveolar lavage (BAL) samples were collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are at analyzed for total cell count (cells/mL) of white blood cell, macrophages, lymphocytes, neutrophils, and eosinophils as a percentage of total cells.
- Change in Concentrations of Inflammatory Marker in Bronchoalveolar Lavage (BAL) [Baseline (Day -1) and Day 55]
The bronchoalveolar lavage (BAL) samples are collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are analyzed for concentrations of tumor necrosis factor (TNF)-alpha, interleukin (IL)-1β, IL-4, IL-5, IL-6, IL-8, IL-13, Myeloperoxidase (MPO), neutrophil elastase (ELA2), monocyte chemotactic protein-1 (MCP-1), myeloperoxidase(MPO), and matrix metalloproteinase-9 (MMP-9).
- Change in Percentage of Total Cells in Blood [Baseline to Day 55]
The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for inflammatory markers (total and differential cell counts as absolute and percentage for neutrophils, macrophages, eosinophils and lymphocytes).
- Change in Concentrations of Inflammatory Marker in Plasma/Blood [Baseline to Day 55]
The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for concentrations of C-reactive protein (CRP), fibrinogen, TNF-α, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-13, MCP-1, and MMP-9. Baseline is Day 1 predose measurement.
- Number of Participants With COPD Exacerbation [Baseline to Day 56]
Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.
- Change From Baseline in Forced Vital Capacity (FVC) [Baseline (Screen) to Day 55]
Forced vital capacity (FVC) is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FVC indicates improvement in lung function.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adult males and/or females, 30 to 85 years of age (inclusive).
-
History of COPD for at least 12 months prior to screening.
-
Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least 12 months prior to screening.
-
Classified as moderate to severe COPD based on the current severity classification GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening
-
etc.
Exclusion Criteria:
-
History of life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
-
History of more than 2 hospitalizations for COPD within 12 months prior to screening.
-
Presentation of an acute exacerbation of COPD that will be associated with increase sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in Period.
-
Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.
-
etc.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UAB Lung Health Center | Birmingham | Alabama | United States | 35249 |
| 2 | Florida Pulmonary Research Institute, LLC | Winter Park | Florida | United States | 32789 |
| 3 | Aventiv Research Inc. | Columbus | Ohio | United States | 43213 |
| 4 | Temple Lung Center, Temple University Hospital | Philadelphia | Pennsylvania | United States | 191140 |
Sponsors and Collaborators
- Yungjin Pharm. Co., Ltd.
Investigators
- Principal Investigator: Gerard J Criner, MD, Temple University
- Principal Investigator: Mark T Dransfield, MD, The Kirklin Clinic of UAB Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- YPL-001_YJP-130403
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | YPL-001 Low Dose | YPL-001 High Dose | Placebo |
|---|---|---|---|
| Arm/Group Description | Active arm including patients who receive the YPL-001 low dose. YPL-001 low dose: twice daily [BID] | Active arm including patients who receive the YPL-001 high dose, YPL-001 high dose: twice daily [BID] | Control arm including patients who receive the placebo drug. Placebo: twice daily [BID] |
| Period Title: Overall Study | |||
| STARTED | 20 | 21 | 20 |
| COMPLETED | 19 | 20 | 19 |
| NOT COMPLETED | 1 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM | Total of all reporting groups |
| Overall Participants | 20 | 21 | 20 | 61 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
65.7
(8.66)
|
60.4
(6.50)
|
61.7
(7.95)
|
62.6
(7.98)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
8
40%
|
8
38.1%
|
9
45%
|
25
41%
|
| Male |
12
60%
|
13
61.9%
|
11
55%
|
36
59%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
1
5%
|
0
0%
|
0
0%
|
1
1.6%
|
| Not Hispanic or Latino |
19
95%
|
21
100%
|
20
100%
|
60
98.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
25%
|
6
28.6%
|
5
25%
|
16
26.2%
|
| White |
15
75%
|
15
71.4%
|
15
75%
|
45
73.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||
| United States |
20
100%
|
21
100%
|
20
100%
|
61
100%
|
| Body mass index (kg/m²) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg/m²] |
28.34
(4.759)
|
27.77
(3.838)
|
26.19
(4.711)
|
27.44
(4.465)
|
Outcome Measures
| Title | Treatment-Emergent Adverse Event Frequency by Treatment - Number of Patients Reporting Events |
|---|---|
| Description | A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo. Safety data for all discontinued patients included in this set for the time points for which their data are available. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM |
| Measure Participants | 20 | 21 | 20 |
| Number of Patients With AEs |
10
50%
|
8
38.1%
|
14
70%
|
| Number of Patients Without AEs |
10
50%
|
13
61.9%
|
6
30%
|
| Title | Treatment-Emergent Adverse Event Frequency by Treatment - Adverse Events |
|---|---|
| Description | A TEAE was defined as an AE that was starting or worsening at the time of or after study drug administration. All AEs collected by the clinics and recorded in the CRF were captured in the database and were listed in by-patient data listings. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo. Safety data for all discontinued patients included in this set for the time points for which their data are available. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM |
| Measure Participants | 20 | 21 | 20 |
| Total Number of AEs |
18
|
14
|
23
|
| Eye disorders |
1
|
1
|
0
|
| Gastrointestinal disorders |
3
|
1
|
1
|
| Infections and infestations |
5
|
3
|
6
|
| Injury, poisoning and procedural complications |
0
|
0
|
2
|
| Metabolism and nutrition disorders |
1
|
0
|
0
|
| Musculoskeletal and connective tissue disorders |
1
|
2
|
0
|
| Nervous system disorders |
0
|
1
|
0
|
| Respiratory, thoracic and mediastinal disorders |
5
|
4
|
13
|
| Skin and subcutaneous tissue disorders |
0
|
1
|
1
|
| Surgical and medical procedures |
1
|
1
|
0
|
| Vascular disorders |
1
|
0
|
0
|
| Title | Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Number of Patients Reporting Events |
|---|---|
| Description | When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo. Safety data for all discontinued patients included in this set for the time points for which their data are available. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM |
| Measure Participants | 20 | 21 | 20 |
| Number of Patients With AEs |
10
50%
|
8
38.1%
|
14
70%
|
| Severity: Mild |
3
15%
|
3
14.3%
|
4
20%
|
| Severity: Moderate |
7
35%
|
5
23.8%
|
9
45%
|
| Severity: Severe |
0
0%
|
0
0%
|
1
5%
|
| Relationship to Drug: Unrelated |
9
45%
|
7
33.3%
|
14
70%
|
| Relationship to Drug: Unlikely |
0
0%
|
1
4.8%
|
0
0%
|
| Relationship to Drug: Possible |
1
5%
|
0
0%
|
0
0%
|
| Relationship to Drug: Probable |
0
0%
|
0
0%
|
0
0%
|
| Relationship to Drug: Definite |
0
0%
|
0
0%
|
0
0%
|
| Title | Treatment-Emergent Adverse Event Frequency by Treatment, Severity, and Relationship to Drug - Adverse Events |
|---|---|
| Description | When a patient experienced the same AE at more than one level of severity, the patient was counted once under the highest severity. |
| Time Frame | Up to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo. Safety data for all discontinued patients included in this set for the time points for which their data are available. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM |
| Measure Participants | 20 | 21 | 20 |
| Number of Adverse Events |
18
|
14
|
23
|
| Severity: Mild |
9
|
8
|
11
|
| Severity: Moderate |
9
|
6
|
11
|
| Severity: Severe |
0
|
0
|
1
|
| Relationship to Drug: Unrelated |
17
|
12
|
23
|
| Relationship to Drug: Unlikely |
0
|
2
|
0
|
| Relationship to Drug: Possible |
1
|
0
|
0
|
| Relationship to Drug: Probable |
0
|
0
|
0
|
| Relationship to Drug: Definite |
0
|
0
|
0
|
| Title | Change From Baseline in Main Peak Expiratory Flow (PEF) Measured Daily |
|---|---|
| Description | The PEF assessments are made daily prior to each dose from Day 1 of the Run-in Period to Day 56 of the Treatment Period. Three measurements were made at each time point using a hand held PEF meter. Readings not performed in the clinical research unit (CRU) were recorded in the patient e-diary. All PEF assessments were performed before administration of a bronchodilator where possible. Baseline is Day 1 predose measurement. |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Baseline (Day1) |
250.0
(109.82)
|
254.9
(68.61)
|
240.7
(68.21)
|
| Day55 |
282.8
(123.61)
|
277.9
(92.08)
|
247.6
(96.17)
|
| Title | Change From Baseline of Symptom Severity Score for Symptoms of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
|---|---|
| Description | Patient is asked to record the major (sputum quality, color, consistency) and minor (cough, wheeze, sore throat, nasal congestion, discharge, and body temperature above 100°F) symptoms of COPD exacerbation via the e-diary before each dosing. Baseline is Day 1 predose measurement Breathlessness(Dyspnea) Screen: 0(None)-10(Extreme): 0: better condition, 10: worse condition Sputum Quantity Screen: None(better)-greater than 1/4 cup(worse) Sputum Color Screen: White(better)-Brown(condition) Sputum Consistency Screen: Watery(better)-Thick(worse) Peak Flow Measurement Screen: 60(better)-800(worse) Symptoms Screen: (Temperature over 100F / Cough/Wheeze/Sore Throat/ Nasal Congestion) Nasal Discharge Screen(Yes/No) * quantitative data were summarized including sample size, arithmetic mean, standard deviation, CV, min and max. Symptom score catecorizes normal(0-0.5), mild(1-1.5), moderate(2-2.5), severe(3-3.5) |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo. Symptom monitoring data for all discontinued patients were included in this set for the time points for which their data are available. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Baseline (Day 1) |
0.63
(0.812)
|
0.17
(0.297)
|
0.47
(0.757)
|
| Day 55 |
0.26
(0.504)
|
0.18
(0.351)
|
0.50
(0.876)
|
| Title | Change From Baseline in Dyspnea (Modified Borg Dyspnea Scale) |
|---|---|
| Description | Severity level of patient's dyspnea is accessed via the modified Borg dyspnea scale programmed within the e-diary. The modified Borg dyspnea scale is a self-administered categorical scale with a score from 0 to 10, where 0 (as a measure of dyspnea) corresponds to the sensation of normal breathing (absence of dyspnea) and 10 corresponds to the patient's maximum possible sensation of dyspnea. |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo. Symptom monitoring data for all discontinued patients were included in this set for the time points for which their data are available. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Baseline (Day 1) |
3.88
(1.996)
|
4.05
(1.746)
|
3.18
(2.512)
|
| Day 55 |
3.76
(2.463)
|
3.88
(2.147)
|
3.31
(2.323)
|
| Title | Change From Baseline of Calculated Score From Duke Activity Status Index (DASI) |
|---|---|
| Description | Patient's functional capacity and activity status were accessed via the DASI programmed within the e-diary. DASI is a self-administered 12-item questionnaire that assesses daily activities such as personal care, ambulation, household tasks, sexual function and recreation with respective metabolic costs. Each item has a specific weight based on the metabolic cost. The final score ranges between 0 and 58.2 points. The higher score shows the better the functional capacity. |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All available data for patients who received at least one dose of the investigational product (i.e., YPL-001) or placebo. Symptom monitoring data for all discontinued patients included in this set for the time points for which their data are available. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Mean (Standard Deviation) [score on a scale] |
-0.267
(3.7696)
|
-2.844
(9.8016)
|
1.137
(4.8336)
|
| Title | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
|---|---|
| Description | Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FEV1 indicates improvement in lung function. |
| Time Frame | Baseline (Screen) to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Mean (Standard Deviation) [L] |
-0.088
(0.2721)
|
-0.002
(0.1974)
|
0.011
(0.1533)
|
| Title | Change From Baseline in Inspiratory Capacity (IC) |
|---|---|
| Description | Inspiratory capacity (IC) is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. IC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. |
| Time Frame | Baseline (Screening) to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Mean (Standard Deviation) [L] |
-0.158
(0.3148)
|
-0.097
(0.4357)
|
-0.304
(0.4709)
|
| Title | Change From Baseline in Forced Expiratory Volume in 1 Second/Forced Vital Capacity (FEV1/FVC) Ratio |
|---|---|
| Description | The ratio is calculated as the amount of air expelled from the lungs in one second after a full inspiration (FEV1) divided by the volume of air that can forcibly be blown out after a full inspiration (FVC). |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Mean (Standard Deviation) [ratio] |
-1.8
(6.21)
|
-0.2
(4.63)
|
2.0
(4.98)
|
| Title | Transition Dyspnea Index (TDI) Focal Score |
|---|---|
| Description | Dyspnea at baseline (Day -1) will be assessed with the Baseline Dyspnea Index (BDI). This instrument has 3 domains (functional impairment, magnitude of task and magnitude of effort) with the values added for a combined focal score. Functional impairment determines the impact of breathlessness on the ability to carry out activities; magnitude of task determines the type of task that causes breathlessness, magnitude of effort establishes the level of effort that results in breathlessness. The BDI scores range from 0 (very severe impairment) to 4 (no impairment) for each domain with the baseline focal score consisting of the sum of each domain (0 to 12). Dyspnea throughout the study will be performed at the time points. The change from baseline is measured by the Transition Dyspnea Index (TDI) score which ranges from -3 (major deterioration) to +3 (major improvement) for each domain with the TDI focal score consisting in the sum of each domain (-9 to +9). |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Mean (Standard Deviation) [units on a scale] |
2.2
(2.68)
|
1.1
(2.75)
|
2.9
(2.84)
|
| Title | Change From Baseline in Chronic Obstructive Pulmonary Disease Assessment Test (CAT) |
|---|---|
| Description | The chronic obstructive pulmonary disease assessment test (CAT) is a short and simple questionnaire of 8 items completed by patients to be performed at the time points. Scores for each of the 8 items are summed to give a single, final score ranging from 0 (no impact on daily activities) to 40 (very high impact on daily activity). |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Mean (Standard Deviation) [units on a scale] |
-1.2
(6.14)
|
-1.3
(5.11)
|
0.0
(7.38)
|
| Title | Change in Percentage of Total Cells in Bronchoalveolar Lavage (BAL) |
|---|---|
| Description | The bronchoalveolar lavage (BAL) samples were collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are at analyzed for total cell count (cells/mL) of white blood cell, macrophages, lymphocytes, neutrophils, and eosinophils as a percentage of total cells. |
| Time Frame | Baseline (Day -1) and Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least one dose of YPL-001 or placebo and provide at least one post-baseline PD measurement. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 20 | 20 |
| WBC |
5.2
(23.16)
|
-2.3
(22.87)
|
-5.6
(21.16)
|
| Eosinohils |
-50.8
(49.25)
|
38.3
(150.97)
|
61.2
(261.73)
|
| Lymphocytes |
37.8
(111.26)
|
2.7
(75.89)
|
19.4
(121.45)
|
| Macrophages |
45.9
(136.88)
|
9.3
(55.48)
|
59.8
(124.05)
|
| Neutrophils |
57.0
(152.70)
|
83.5
(252.98)
|
1.1
(106.19)
|
| Title | Change in Concentrations of Inflammatory Marker in Bronchoalveolar Lavage (BAL) |
|---|---|
| Description | The bronchoalveolar lavage (BAL) samples are collected at baseline and again at the completion of the study for pharmacodynamics (PD) assessments of biomarkers. BAL samples are analyzed for concentrations of tumor necrosis factor (TNF)-alpha, interleukin (IL)-1β, IL-4, IL-5, IL-6, IL-8, IL-13, Myeloperoxidase (MPO), neutrophil elastase (ELA2), monocyte chemotactic protein-1 (MCP-1), myeloperoxidase(MPO), and matrix metalloproteinase-9 (MMP-9). |
| Time Frame | Baseline (Day -1) and Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least one dose of YPL-001 or placebo and provide at least one post-baseline PD measurement. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 17 | 20 | 18 |
| ELA2(neutrophil elastage) |
46.36
(154.476)
|
714.18
(1864.367)
|
155.57
(523.538)
|
| IL-13 |
34.47
(187.126)
|
321.42
(1168.485)
|
160.25
(243.317)
|
| IL-1ß |
79.65
(216.674)
|
223.62
(618.896)
|
45.43
(207.504)
|
| IL-4 |
11.12
(101.995)
|
121.13
(258.496)
|
155.36
(276.287)
|
| IL-5 |
49.97
(161.255)
|
220.88
(523.979)
|
213.86
(341.157)
|
| IL-6 |
-7.41
(79.289)
|
130.15
(354.531)
|
53.48
(153.791)
|
| IL-8 |
50.61
(178.116)
|
173.57
(600.987)
|
45.40
(222.303)
|
| MCP-1 |
90.05
(224.213)
|
155.50
(601.606)
|
252.95
(816.196)
|
| MMP-9 |
28.38
(201.899)
|
565.88
(2067.142)
|
43.31
(242.912)
|
| MPO |
64.14
(243.237)
|
275.50
(693.932)
|
62.14
(199.545)
|
| TNF-a |
14.04
(114.456)
|
268.19
(863.815)
|
124.20
(266.423)
|
| Title | Change in Percentage of Total Cells in Blood |
|---|---|
| Description | The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for inflammatory markers (total and differential cell counts as absolute and percentage for neutrophils, macrophages, eosinophils and lymphocytes). |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least one dose of YPL-001 or placebo and provide at least one post-baseline PD measurement. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| WBC |
5.229
(23.1568)
|
-2.289
(22.8687)
|
-5.572
(21.1569)
|
| Eosinophils |
7.61728
(78.203389)
|
20.06903
(91.240833)
|
57.36857
(226.50576)
|
| Lymphocytes |
10.21926
(35.449159)
|
-1.58746
(23.455210)
|
14.24407
(26.363322)
|
| Monocytes |
0.05858
(24.446709)
|
30.65211
(65.329419)
|
1.67563
(46.936967)
|
| Neutrophils |
1.62215
(24.058407)
|
0.13700
(10.8890617)
|
-3.29570
(10.559662)
|
| Title | Change in Concentrations of Inflammatory Marker in Plasma/Blood |
|---|---|
| Description | The blood samples are collected at the the time points of the study for pharmacodynamics (PD) assessments of biomarkers. The blood samples are analyzed for concentrations of C-reactive protein (CRP), fibrinogen, TNF-α, IL-1β, IL-4, IL-5, IL-6, IL-8, IL-13, MCP-1, and MMP-9. Baseline is Day 1 predose measurement. |
| Time Frame | Baseline to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who received at least one dose of YPL-001 or placebo and provide at least one post-baseline PD measurement. |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| ELA2 |
-7.13
(30.726)
|
-17.01
(33.050)
|
-26.33
(30.972)
|
| IL-13 |
5.158
(45.4151)
|
10.197
(53.7029)
|
-1.622
(5.5691)
|
| IL-1ß |
44.9813
(149.88595)
|
32.7901
(121.71539)
|
4.7453
(72.39394)
|
| IL-4 |
68.849
(280.7619)
|
22.678
(98.3923)
|
-19.865
(35.6127)
|
| IL-5 |
73.36
(214.724)
|
20.57
(257.416)
|
-5.30
(99.117)
|
| IL-6 |
-26.0682
(36.92257)
|
-35.8383
(82.30541)
|
-48.4230
(51.59468)
|
| IL-8 |
26.916
(47.0832)
|
6.986
(54.7421)
|
57.464
(176.8141)
|
| MCP1 |
20.019
(86.8398)
|
-13.923
(31.9128)
|
51.441
(173.5531)
|
| MMP9 |
-10.922
(52.3542)
|
-9.087
(39.4842)
|
-27.524
(34.8440)
|
| MPO |
-6.051
(21.3202)
|
-9.661
(26.7605)
|
-14.232
(26.6217)
|
| TNF-α |
-10.499
(24.7753)
|
-16.184
(25.6551)
|
-1.585
(27.5520)
|
| CRP |
-12.087
(102.3304)
|
29.028
(345.0216)
|
-61.732
(40.0405)
|
| Fibrinogen |
0.5
(15.39)
|
-0.4
(13.88)
|
-7.7
(22.38)
|
| Title | Number of Participants With COPD Exacerbation |
|---|---|
| Description | Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits. |
| Time Frame | Baseline to Day 56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 and QD on Day 56 AM | Multiple oral doses of placebo BID on Days 1 - 55 and QD on Day 56 AM |
| Measure Participants | 20 | 21 | 20 |
| Count of Participants [Participants] |
3
15%
|
2
9.5%
|
5
25%
|
| Title | Change From Baseline in Forced Vital Capacity (FVC) |
|---|---|
| Description | Forced vital capacity (FVC) is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC is measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation. A positive change from baseline in FVC indicates improvement in lung function. |
| Time Frame | Baseline (Screen) to Day 55 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis population included data obtained from all the subjects who were enrolled in the study and received at least one dose of the investigational drug and had primary efficacy endpoint after administration of the investigational drug |
| Arm/Group Title | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 |
| Measure Participants | 19 | 21 | 20 |
| Mean (Standard Deviation) [L] |
-0.087
(0.3475)
|
0.007
(0.2290)
|
-0.105
(0.3117)
|
Adverse Events
| Time Frame | 56 days | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Treatment A | Treatment B | Treatment C | |||
| Arm/Group Description | Multiple oral doses of YPL-001 80 mg BID on Days 1 - 55 | Multiple oral doses of YPL-001 160 mg BID on Days 1 - 55 | Multiple oral doses of placebo BID on Days 1 - 55 | |||
All Cause Mortality |
||||||
| Treatment A | Treatment B | Treatment C | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/21 (0%) | 0/20 (0%) | |||
Serious Adverse Events |
||||||
| Treatment A | Treatment B | Treatment C | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/21 (0%) | 1/20 (5%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute Exacerbation of COPD | 0/20 (0%) | 0/21 (0%) | 1/20 (5%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Treatment A | Treatment B | Treatment C | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/20 (50%) | 8/21 (38.1%) | 14/20 (70%) | |||
| Eye disorders | ||||||
| Dry eye | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Eye irritation | 0/20 (0%) | 0 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Diarrhoea | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Dry mouth | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Dyspepsia | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Large intestine polyp | 0/20 (0%) | 0 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Nausea | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Infections and infestations | ||||||
| Bronchitis | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Bronchopneumonia | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Epididymitis | 0/20 (0%) | 0 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Folliculitis | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Gastroenteritis viral | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Herpes zoster | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Nasopharyngitis | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 0 |
| Subcutaneous abscess | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 0 |
| Upper respiratory tract infection | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 2/20 (10%) | 2 |
| Urinary tract infection | 1/20 (5%) | 1 | 2/21 (9.5%) | 2 | 0/20 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Chest injury | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Skeletal injury | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Diabetes mellitus | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/20 (0%) | 0 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Neck pain | 1/20 (5%) | 1 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Nervous system disorders | ||||||
| Dizziness | 0/20 (0%) | 0 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Chronic obstructive pulmonary disease | 3/20 (15%) | 3 | 2/21 (9.5%) | 2 | 5/20 (25%) | 5 |
| Cough | 0/20 (0%) | 0 | 2/21 (9.5%) | 2 | 5/20 (25%) | 5 |
| Dyspnoea | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Oropharyngeal pain | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Rhinitis allergic | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Rhinorrhoea | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Drug eruption | 0/20 (0%) | 0 | 0/21 (0%) | 0 | 1/20 (5%) | 1 |
| Rash | 0/20 (0%) | 0 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Surgical and medical procedures | ||||||
| Large intestinal polypectomy | 0/20 (0%) | 0 | 1/21 (4.8%) | 1 | 0/20 (0%) | 0 |
| Tooth extraction | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 1/20 (5%) | 1 | 0/21 (0%) | 0 | 0/20 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Director of Clinical Trials |
|---|---|
| Organization | Yungjin Pharm. Co., Ltd. |
| Phone | 82-2-2041-8318 |
| mhlee2017@yungjin.co.kr |
- YPL-001_YJP-130403