Trial Outcomes & Findings for Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug (NCT NCT03235726)
NCT ID: NCT03235726
Last Updated: 2020-07-08
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Up to 51 days
Results posted on
2020-07-08
Participant Flow
This was a two parts single and repeat dose escalation study. Part 1 was conducted in healthy volunteers and Part 2 was conducted in participants with moderate chronic obstructive pulmonary disease (COPD).
A total of 52 participants (36 in Part 1 and 16 in Part 2) were enrolled in this study. This study was conducted at a single center in the United Kingdom from 13-July-2017 to 19-June-2018.
Participant milestones
| Measure |
Part 1: Cohort A- CCI15106 60 mg SD
Healthy participants were administered a single dose (SD) of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 30 mg BID
Healthy participants were administered a twice daily (BID) dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
|
Part 1: Cohort A- Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort B- Placebo
Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Cohort C- Bystanders
Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
|
Part 2: Cohort A- CCI15106 60 mg SD
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort A- Placebo
Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort A 60 mg - Day 1)
STARTED
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6
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0
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0
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2
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort A 60 mg - Day 1)
COMPLETED
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6
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0
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0
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2
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort A 60 mg - Day 1)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort A 120 mg - Day 3)
STARTED
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0
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6
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0
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2
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0
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0
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0
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0
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0
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Part 1 (Cohort A 120 mg - Day 3)
COMPLETED
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0
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6
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0
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2
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort A 120 mg - Day 3)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort A 30mg BID-Days 6 to 19)
STARTED
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0
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0
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6
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2
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort A 30mg BID-Days 6 to 19)
COMPLETED
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0
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0
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6
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2
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort A 30mg BID-Days 6 to 19)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 1 (Cohort B and C- Days 1 to 14)
STARTED
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0
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0
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0
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0
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12
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2
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14
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0
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0
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0
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Part 1 (Cohort B and C- Days 1 to 14)
COMPLETED
|
0
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0
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0
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0
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10
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2
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14
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0
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0
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0
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Part 1 (Cohort B and C- Days 1 to 14)
NOT COMPLETED
|
0
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0
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0
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0
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2
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0
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0
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0
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0
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0
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Part 2 (Cohort A - Day 1)
STARTED
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0
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0
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0
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0
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0
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0
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0
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6
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2
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0
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Part 2 (Cohort A - Day 1)
COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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6
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2
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0
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Part 2 (Cohort A - Day 1)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Part 2 (Cohort B - Days 1 to 14)
STARTED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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8
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Part 2 (Cohort B - Days 1 to 14)
COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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8
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Part 2 (Cohort B - Days 1 to 14)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Part 1: Cohort A- CCI15106 60 mg SD
Healthy participants were administered a single dose (SD) of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 30 mg BID
Healthy participants were administered a twice daily (BID) dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
|
Part 1: Cohort A- Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort B- Placebo
Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Cohort C- Bystanders
Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
|
Part 2: Cohort A- CCI15106 60 mg SD
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort A- Placebo
Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1 (Cohort B and C- Days 1 to 14)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part 1 (Cohort B and C- Days 1 to 14)
Drug was prematurely discontinued
|
0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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Baseline Characteristics
Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug
Baseline characteristics by cohort
| Measure |
Part 1: Cohort A- CCI15106
n=6 Participants
Healthy participants were administered a SD dose of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
|
Part 1: Cohort A- Placebo
n=2 Participants
Healthy participants were administered a SD dose of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01, followed by a SD dose of matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01, further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort B- Placebo
n=2 Participants
Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Cohort C- Bystanders
n=14 Participants
Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
|
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort A- Placebo
n=2 Participants
Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
45 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
47 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
43 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American and White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American and Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 51 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician. Safety population comprised of all participants who received at least one dose of study treatment during the study.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=2 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106
NSAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106
NSAEs
|
6 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106
SAEs
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders
NSAEs
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders
SAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 33 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: Number of Participants With NSAEs and SAEs
NSAEs
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort A: Number of Participants With NSAEs and SAEs
SAEs
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort B: Number of Participants With NSAEs and SAEs
NSAEs
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: Number of Participants With NSAEs and SAEs
SAEs
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 51 daysPopulation: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of red blood cell \[RBC\] in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 grams \[g\]/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Lymphocytes: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Neutrophil count: low
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Platelet count: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Platelet count: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Hematocrit: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106
Hemoglobin: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Hematocrit: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Hemoglobin: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Lymphocytes: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Neutrophil count: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Platelet count: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Hematology Values of PCI in Bystanders
Platelet count: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the hematology parameters were as follows: hematocrit (high: \>0.54 proportion of RBC in blood for male, \>0.54 proportion of RBC in blood for female), hemoglobin (high: \>180 g/L in male, \>180 g/L in female), lymphocytes (low: \<0.8 10\^9/L), neutrophil count (low: \<1.5 10\^9/L) and platelet count (low: \<100 10\^9/L and high: 550 10\^9/L). Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Hematology Values of PCI
Hematocrit: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Hematology Values of PCI
Hemoglobin: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Hematology Values of PCI
Lymphocytes: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Hematology Values of PCI
Neutrophil count: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Hematology Values of PCI
Platelet count: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Hematology Values of PCI
Platelet count: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 51 daysPopulation: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 millimole per liter \[mmol/L\]), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Albumin: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Calcium: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Calcium: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Glucose: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Glucose: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Potassium: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Potassium: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Sodium: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106
Sodium: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Albumin: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Calcium: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Calcium: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Glucose: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Glucose: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Potassium: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Potassium: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Sodium: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders
Sodium: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<30 mmol/L), calcium (low: \<2 mmol/L and high: \>2.75 mmol/L), glucose (low: \<3 mmol/L and high: \>9 mmol/L), potassium (low: \<3 mmol/L and high: \>5.5 mmol/L) and sodium (low: \<130 mmol/L and high: \>150 mmol/L). Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Albumin: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Calcium: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Calcium: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Glucose: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Glucose: high
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Potassium: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Potassium: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Sodium: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Clinical Chemistry Values of PCI
Sodium: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 2Population: Safety Population.
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD
Baseline
|
6.00 pH
Standard Deviation 0.000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD
Day 2
|
6.33 pH
Standard Deviation 0.816
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: Safety Population.
Urine sample was collected from participants at indicated time point for analysis of pH.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD
|
6.58 pH
Standard Deviation 0.736
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 12 and 22Population: Safety Population.
Urine samples were collected from participants at indicated time points for analysis of pH.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID
Day 12
|
6.50 pH
Standard Deviation 0.949
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID
Day 22
|
6.92 pH
Standard Deviation 0.665
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 7 and 15Population: Safety Population.
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Baseline
|
6.21 pH
Standard Deviation 0.811
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Day 7
|
6.63 pH
Standard Deviation 0.882
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Day 15
|
6.21 pH
Standard Deviation 0.620
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=4 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: pH Value by Visit- Placebo
Baseline: n=4
|
6.50 pH
Standard Deviation 0.707
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: pH Value by Visit- Placebo
Day 2: n=2
|
5.50 pH
Standard Deviation 0.707
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: pH Value by Visit- Placebo
Day 5: n=2
|
6.25 pH
Standard Deviation 0.354
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: pH Value by Visit- Placebo
Day 7: n=2
|
7.00 pH
Standard Deviation 1.414
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: pH Value by Visit- Placebo
Day 12: n=2
|
5.75 pH
Standard Deviation 1.061
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: pH Value by Visit- Placebo
Day 15: n=2
|
5.50 pH
Standard Deviation 0.707
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: pH Value by Visit- Placebo
Day 22: n=2
|
6.75 pH
Standard Deviation 1.061
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 7 and 15Population: Safety Population.
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
Baseline
|
6.36 pH
Standard Deviation 0.633
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
Day 7
|
6.36 pH
Standard Deviation 0.719
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders
Day 15
|
5.96 pH
Standard Deviation 0.499
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 2Population: Safety Population.
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: pH Value by Visit- CCI15106
Baseline
|
6.25 pH
Standard Deviation 0.822
|
—
|
6.75 pH
Standard Deviation 1.061
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort A: pH Value by Visit- CCI15106
Day 2
|
6.58 pH
Standard Deviation 0.801
|
—
|
6.50 pH
Standard Deviation 0.707
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 7 and 15Population: Safety Population.
Urine samples were collected from participants at indicated time points for analysis of pH. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Baseline
|
6.13 pH
Standard Deviation 0.916
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Day 7
|
5.94 pH
Standard Deviation 0.863
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID
Day 15
|
5.81 pH
Standard Deviation 0.884
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 2Population: Safety Population.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD
Baseline
|
1.0217 Ratio
Standard Deviation 0.01033
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD
Day 2
|
1.0105 Ratio
Standard Deviation 0.00625
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 5Population: Safety Population.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine sample was collected from participants at indicated time point for analysis of specific gravity.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD
|
1.0182 Ratio
Standard Deviation 0.00722
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 12 and 22Population: Safety Population.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID
Day 12
|
1.0115 Ratio
Standard Deviation 0.00442
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID
Day 22
|
1.0115 Ratio
Standard Deviation 0.00442
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 7 and 15Population: Safety Population.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Baseline
|
1.0136 Ratio
Standard Deviation 0.00734
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Day 7
|
1.0152 Ratio
Standard Deviation 0.01039
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Day 15
|
1.0167 Ratio
Standard Deviation 0.00444
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 2, 5, 7, 12, 15 and 22Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of Specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=4 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Specific Gravity Value by Visit- Placebo
Baseline: n=4
|
1.0148 Ratio
Standard Deviation 0.00858
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Specific Gravity Value by Visit- Placebo
Day 2: n=2
|
1.0150 Ratio
Standard Deviation 0.00000
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Specific Gravity Value by Visit- Placebo
Day 5: n=2
|
1.0150 Ratio
Standard Deviation 0.00707
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Specific Gravity Value by Visit- Placebo
Day 7: n=2
|
1.0150 Ratio
Standard Deviation 0.00707
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Specific Gravity Value by Visit- Placebo
Day 12: n=2
|
1.0120 Ratio
Standard Deviation 0.01131
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Specific Gravity Value by Visit- Placebo
Day 15: n=2
|
1.0150 Ratio
Standard Deviation 0.00707
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Specific Gravity Value by Visit- Placebo
Day 22: n=2
|
1.0095 Ratio
Standard Deviation 0.00778
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 7 and 15Population: Safety Population.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
Baseline
|
1.0191 Ratio
Standard Deviation 0.01339
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
Day 7
|
1.0163 Ratio
Standard Deviation 0.00907
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders
Day 15
|
1.0182 Ratio
Standard Deviation 0.00750
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1) and Day 2Population: Safety Population.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106
Baseline
|
1.0205 Ratio
Standard Deviation 0.01694
|
—
|
1.0175 Ratio
Standard Deviation 0.01061
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106
Day 2
|
1.0147 Ratio
Standard Deviation 0.00737
|
—
|
1.0275 Ratio
Standard Deviation 0.01768
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day -1), Days 7 and 15Population: Safety Population.
Urinary specific gravity measurement is a routine part of urinalysis. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. The concentration of the excreted molecules determines the urine's specific gravity. Urine samples were collected from participants at indicated time points for analysis of specific gravity. Baseline was considered as the latest pre-dose assessment with a non-missing value for Baseline (Day -1).
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Baseline
|
1.0106 Ratio
Standard Deviation 0.00678
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Day 7
|
1.0114 Ratio
Standard Deviation 0.00424
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID
Day 15
|
1.0133 Ratio
Standard Deviation 0.00523
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 51 daysPopulation: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 milliseconds (msec), absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. QTcF=Frederica's QT interval corrected for heart rate; QTcB=Bazett's QT interval corrected for heart rate. Data for worst case post-Baseline has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
PR interval: Value<110
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
PR interval: 110<=Value<=220
|
6 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
PR interval: Value>220
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QRS duration: Value<75
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QRS duration: 75<=Value<=110
|
4 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
3 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QRS duration: Value>110
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QT interval: Value<=450
|
5 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QT interval: 450<Value<480
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QT interval: 480<=Value<500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QT interval: Value>=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcB interval: Value<=450
|
6 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcB interval: 450<Value<480
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcB interval: 480<=Value<500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcB interval: Value>=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcF interval: Value<=450
|
6 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
4 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcF interval: 450<Value<480
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcF interval: 480<=Value<500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106
QTcF interval: Value>=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
PR interval: Value<110
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
PR interval: 110<=Value<=220
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
PR interval: Value>220
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QRS duration: Value<75
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QRS duration: 75<=Value<=110
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QRS duration: Value>110
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QT interval: Value<=450
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QT interval: 450<Value<480
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QT interval: 480<=Value<500
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QT interval: Value>=500
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcB interval: Value<=450
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcB interval: 450<Value<480
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcB interval: 480<=Value<500
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcB interval: Value>=500
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcF interval: Value<=450
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcF interval: 450<Value<480
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcF interval: 480<=Value<500
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander
QTcF interval: Value>=500
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the ECG parameters were as follows: absolute QTc interval \>450 and \<480, \>=480 and \<500, \>=500 msec, absolute PR interval \<110 and \>220 msec and absolute QRS interval \<75 and \>110 msec. Data for worst case post-Baseline has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcB interval: 450<Value<480
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcB interval: 480<=Value<500
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QT interval: Value>=500
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcB interval: Value<=450
|
5 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
PR interval: Value<110
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
PR interval: 110<=Value<=220
|
5 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
PR interval: Value>220
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QRS duration: Value<75
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QRS duration: 75<=Value<=110
|
5 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QRS duration: Value>110
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QT interval: Value<=450
|
6 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QT interval: 450<Value<480
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QT interval: 480<=Value<500
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcB interval: Value>=500
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcF interval: Value<=450
|
6 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcF interval: 450<Value<480
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcF interval: 480<=Value<500
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI
QTcF interval: Value>=500
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 3, 6, 7, 12 and 18: 0.5 hour (pre-dose) to 4 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as clinically significant (CS) and not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 1: 0.5 to 4 hours post-dose-CS;n=6,0,0,12,4
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 1: 0.5 to 4 hours post-dose-NCS;n=6,0,0,12,4
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 3: 0.5 to 4 hours post-dose-CS;n=0,6,0,0,2
|
—
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 3: 0.5 to 4 hours post-dose-NCS;n=0,6,0,0,2
|
—
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 6: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 6: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 7: 0.5 to 4 hours post-dose-CS;n=0,0,0,12,2
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 7: 0.5 to 4 hours post-dose-NCS;n=0,0,0,12,2
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 12: 0.5 to 4 hours post-dose-CS;n=0,0,6,12,4
|
—
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 12: 0.5 to 4 hours post-dose-NCS;n=0,0,6,12,4
|
—
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 18: 0.5 to 4 hours post-dose-CS;n=0,0,6,0,2
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Abnormal Telemetry Findings
Day 18: 0.5 to 4 hours post-dose-NCS;n=0,0,6,0,2
|
—
|
0 Participants
|
—
|
—
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7, 12 and 13: 0.5 hour (pre-dose) to 4 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Continuous cardiac telemetry was performed from approximately 0.5 hour (pre-dose) to 4 hours post-dose. Abnormal findings were categorized as CS and NCS. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 1: 0.5 to 4 hours post-dose-CS; n=6,2,8
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 1: 0.5 to 4 hours post-dose-NCS; n=6,2,8
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 7: 0.5 to 4 hours post-dose-CS; n=0,0,8
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 7: 0.5 to 4 hours post-dose-NCS; n=0,0,8
|
—
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 12: 0.5 to 4 hours post-dose-CS; n=0,0,5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 12: 0.5 to 4 hours post-dose-NCS; n=0,0,5
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 13: 0.5 to 4 hours post-dose-CS; n=0,0,3
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Abnormal Telemetry Findings
Day 13: 0.5 to 4 hours post-dose-NCS; n=0,0,3
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
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Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
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Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 1: pre-dose, n=6,0,0,12,4
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101.0 Percent predicted FEV1
Standard Deviation 8.49
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101.1 Percent predicted FEV1
Standard Deviation 15.31
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102.0 Percent predicted FEV1
Standard Deviation 9.35
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 1: 0.25 hour, n=6,0,0,0,2
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101.5 Percent predicted FEV1
Standard Deviation 7.87
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99.0 Percent predicted FEV1
Standard Deviation 14.14
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 1: 0.5 hour, n=6,0,0,12,4
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104.3 Percent predicted FEV1
Standard Deviation 7.17
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100.3 Percent predicted FEV1
Standard Deviation 13.94
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102.5 Percent predicted FEV1
Standard Deviation 12.82
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 1: 1 hour, n=6,0,0,12,4
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105.2 Percent predicted FEV1
Standard Deviation 6.62
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102.2 Percent predicted FEV1
Standard Deviation 14.86
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103.8 Percent predicted FEV1
Standard Deviation 11.56
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 1: 4 hours, n=6,0,0,12,4
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104.5 Percent predicted FEV1
Standard Deviation 8.04
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101.4 Percent predicted FEV1
Standard Deviation 16.20
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104.3 Percent predicted FEV1
Standard Deviation 11.76
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 3: pre-dose, n=0,6,0,12,4
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103.2 Percent predicted FEV1
Standard Deviation 5.71
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101.5 Percent predicted FEV1
Standard Deviation 14.47
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105.3 Percent predicted FEV1
Standard Deviation 12.45
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 3: 0.25 hour, n=0,6,0,0,2
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103.2 Percent predicted FEV1
Standard Deviation 6.49
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102.5 Percent predicted FEV1
Standard Deviation 19.09
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 3: 0.5 hour, n=0,6,0,0,2
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103.0 Percent predicted FEV1
Standard Deviation 5.97
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100.0 Percent predicted FEV1
Standard Deviation 18.38
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 3: 1 hour, n=0,6,0,0,2
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104.3 Percent predicted FEV1
Standard Deviation 6.68
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101.0 Percent predicted FEV1
Standard Deviation 16.97
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 3: 4 hours, n=0,6,0,12,4
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106.7 Percent predicted FEV1
Standard Deviation 7.00
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103.1 Percent predicted FEV1
Standard Deviation 15.64
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106.8 Percent predicted FEV1
Standard Deviation 12.95
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 6: pre-dose, n=0,0,6,12,4
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104.5 Percent predicted FEV1
Standard Deviation 5.61
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101.3 Percent predicted FEV1
Standard Deviation 15.69
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102.8 Percent predicted FEV1
Standard Deviation 10.94
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 6: 0.25 hour, n=0,0,6,0,2
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102.3 Percent predicted FEV1
Standard Deviation 6.80
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101.5 Percent predicted FEV1
Standard Deviation 17.68
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 6: 0.5 hour, n=0,0,6,0,2
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103.5 Percent predicted FEV1
Standard Deviation 7.31
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101.0 Percent predicted FEV1
Standard Deviation 18.38
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 6: 1 hour, n=0,0,6,0,2
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104.0 Percent predicted FEV1
Standard Deviation 6.26
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99.0 Percent predicted FEV1
Standard Deviation 18.38
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 6: 4 hours, n=0,0,6,12,4
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106.3 Percent predicted FEV1
Standard Deviation 3.93
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104.0 Percent predicted FEV1
Standard Deviation 15.50
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105.5 Percent predicted FEV1
Standard Deviation 10.66
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 8: pre-dose, n=0,0,6,0,2
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105.0 Percent predicted FEV1
Standard Deviation 5.73
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103.0 Percent predicted FEV1
Standard Deviation 16.97
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 8: 4 hours, n=0,0,6,0,2
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104.7 Percent predicted FEV1
Standard Deviation 4.50
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103.5 Percent predicted FEV1
Standard Deviation 17.68
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 11: pre-dose, n=0,0,6,12,4
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103.3 Percent predicted FEV1
Standard Deviation 3.88
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101.6 Percent predicted FEV1
Standard Deviation 16.76
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106.0 Percent predicted FEV1
Standard Deviation 11.28
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 11: 4 hours, n=0,0,6,12,4
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105.0 Percent predicted FEV1
Standard Deviation 6.69
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103.6 Percent predicted FEV1
Standard Deviation 15.84
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107.0 Percent predicted FEV1
Standard Deviation 10.42
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 14: pre-dose, n=0,0,0,11,2
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101.0 Percent predicted FEV1
Standard Deviation 16.84
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105.5 Percent predicted FEV1
Standard Deviation 6.36
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 14: 0.5 hour, n=0,0,0,11,2
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100.7 Percent predicted FEV1
Standard Deviation 15.88
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104.0 Percent predicted FEV1
Standard Deviation 8.49
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 14: 1 hour, n=0,0,0,12,2
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99.1 Percent predicted FEV1
Standard Deviation 16.09
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107.5 Percent predicted FEV1
Standard Deviation 6.36
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 14: 4 hours, n=0,0,0,12,2
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97.3 Percent predicted FEV1
Standard Deviation 16.23
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112.5 Percent predicted FEV1
Standard Deviation 9.19
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 16: pre-dose, n=0,0,6,0,2
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102.5 Percent predicted FEV1
Standard Deviation 5.32
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104.5 Percent predicted FEV1
Standard Deviation 17.68
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 16: 4 hours, n=0,0,6,0,2
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105.3 Percent predicted FEV1
Standard Deviation 6.38
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104.0 Percent predicted FEV1
Standard Deviation 19.80
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 19: pre-dose, n=0,0,6,0,2
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101.7 Percent predicted FEV1
Standard Deviation 7.47
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104.0 Percent predicted FEV1
Standard Deviation 18.38
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 19: 0.25 hour, n=0,0,6,0,2
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102.5 Percent predicted FEV1
Standard Deviation 6.72
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99.5 Percent predicted FEV1
Standard Deviation 20.51
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 19: 0.5 hour, n=0,0,6,0,2
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102.7 Percent predicted FEV1
Standard Deviation 10.09
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103.0 Percent predicted FEV1
Standard Deviation 18.38
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 19: 1 hour, n=0,0,6,0,2
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99.3 Percent predicted FEV1
Standard Deviation 9.29
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103.5 Percent predicted FEV1
Standard Deviation 16.26
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Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points
Day 19: 4 hours, n=0,0,6,0,2
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104.0 Percent predicted FEV1
Standard Deviation 6.78
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103.0 Percent predicted FEV1
Standard Deviation 15.56
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PRIMARY outcome
Timeframe: Days 1, 3, 6 and 19: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 8, 11 and 16: pre-dose and 4 hours post-dose; Day 14: pre-dose, 0.5, 1 and 4 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
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Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
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Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
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Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
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Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
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Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
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Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 1: pre-dose, n=6,0,0,12,4
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101.2 Percent predicted FVC
Standard Deviation 7.14
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104.1 Percent predicted FVC
Standard Deviation 14.19
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102.0 Percent predicted FVC
Standard Deviation 2.58
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 1: 0.25 hour, n=6,0,0,0,2
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101.5 Percent predicted FVC
Standard Deviation 8.41
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102.0 Percent predicted FVC
Standard Deviation 5.66
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 1: 0.5 hour, n=6,0,0,12,4
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108.3 Percent predicted FVC
Standard Deviation 7.31
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102.4 Percent predicted FVC
Standard Deviation 13.28
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103.8 Percent predicted FVC
Standard Deviation 2.87
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 1: 1 hour, n=6,0,0,12,4
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109.8 Percent predicted FVC
Standard Deviation 7.96
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103.7 Percent predicted FVC
Standard Deviation 13.66
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105.3 Percent predicted FVC
Standard Deviation 2.50
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 1: 4 hours, n=6,0,0,12,4
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106.7 Percent predicted FVC
Standard Deviation 8.94
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103.4 Percent predicted FVC
Standard Deviation 14.74
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104.5 Percent predicted FVC
Standard Deviation 4.36
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 3: pre-dose, n=0,6,0,12,4
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104.3 Percent predicted FVC
Standard Deviation 6.92
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105.0 Percent predicted FVC
Standard Deviation 14.68
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105.8 Percent predicted FVC
Standard Deviation 2.63
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 3: 0.25 hour, n=0,6,0,0,2
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105.7 Percent predicted FVC
Standard Deviation 8.50
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106.5 Percent predicted FVC
Standard Deviation 3.54
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 3: 0.5 hour, n=0,6,0,0,2
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105.0 Percent predicted FVC
Standard Deviation 8.00
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104.5 Percent predicted FVC
Standard Deviation 3.54
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 3: 1 hour, n=0,6,0,0,2
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105.8 Percent predicted FVC
Standard Deviation 8.01
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105.0 Percent predicted FVC
Standard Deviation 1.41
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 3: 4 hours, n=0,6,0,12,4
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106.5 Percent predicted FVC
Standard Deviation 6.72
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105.3 Percent predicted FVC
Standard Deviation 14.91
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105.0 Percent predicted FVC
Standard Deviation 2.16
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 6: pre-dose, n=0,0,6,12,4
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107.8 Percent predicted FVC
Standard Deviation 7.08
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103.7 Percent predicted FVC
Standard Deviation 14.77
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103.3 Percent predicted FVC
Standard Deviation 2.22
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 6: 0.25 hour, n=0,0,6,0,2
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104.7 Percent predicted FVC
Standard Deviation 8.33
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104.5 Percent predicted FVC
Standard Deviation 2.12
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 6: 0.5 hour, n=0,0,6,0,2
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105.7 Percent predicted FVC
Standard Deviation 9.81
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103.5 Percent predicted FVC
Standard Deviation 2.12
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 6: 1 hour, n=0,0,6,0,2
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106.0 Percent predicted FVC
Standard Deviation 9.14
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99.5 Percent predicted FVC
Standard Deviation 10.61
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 6: 4 hours, n=0,0,6,12,4
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110.2 Percent predicted FVC
Standard Deviation 7.08
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105.4 Percent predicted FVC
Standard Deviation 14.85
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104.8 Percent predicted FVC
Standard Deviation 3.30
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 8: pre-dose, n=0,0,6,0,2
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108.8 Percent predicted FVC
Standard Deviation 8.47
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108.0 Percent predicted FVC
Standard Deviation 1.41
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 8: 4 hours, n=0,0,6,0,2
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108.2 Percent predicted FVC
Standard Deviation 8.47
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108.0 Percent predicted FVC
Standard Deviation 2.83
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 11: pre-dose, n=0,0,6,12,4
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107.2 Percent predicted FVC
Standard Deviation 7.41
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104.3 Percent predicted FVC
Standard Deviation 17.05
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106.8 Percent predicted FVC
Standard Deviation 6.13
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 11: 4 hours, n=0,0,6,12,4
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107.8 Percent predicted FVC
Standard Deviation 8.86
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106.3 Percent predicted FVC
Standard Deviation 17.43
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107.0 Percent predicted FVC
Standard Deviation 5.35
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 14: pre-dose, n=0,0,0,11,2
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—
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—
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104.7 Percent predicted FVC
Standard Deviation 16.01
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102.5 Percent predicted FVC
Standard Deviation 3.54
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—
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 14: 0.5 hour, n=0,0,0,11,2
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—
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103.6 Percent predicted FVC
Standard Deviation 14.52
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100.5 Percent predicted FVC
Standard Deviation 0.71
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—
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 14: 1 hour, n=0,0,0,12,2
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—
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—
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100.8 Percent predicted FVC
Standard Deviation 14.91
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104.0 Percent predicted FVC
Standard Deviation 1.41
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—
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 14: 4 hours, n=0,0,0,11,2
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—
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—
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99.0 Percent predicted FVC
Standard Deviation 16.81
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106.0 Percent predicted FVC
Standard Deviation 0.00
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—
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—
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 16: pre-dose, n=0,0,6,0,2
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107.7 Percent predicted FVC
Standard Deviation 8.04
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—
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111.0 Percent predicted FVC
Standard Deviation 4.24
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—
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 16: 4 hours, n=0,0,6,0,2
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108.5 Percent predicted FVC
Standard Deviation 8.38
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—
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110.5 Percent predicted FVC
Standard Deviation 6.36
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—
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 19: pre-dose, n=0,0,6,0,2
|
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104.0 Percent predicted FVC
Standard Deviation 10.32
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—
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110.0 Percent predicted FVC
Standard Deviation 4.24
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—
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Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 19: 0.25 hour, n=0,0,6,0,2
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105.7 Percent predicted FVC
Standard Deviation 10.07
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—
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—
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107.0 Percent predicted FVC
Standard Deviation 7.07
|
—
|
—
|
|
Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 19: 0.5 hour, n=0,0,6,0,2
|
—
|
104.3 Percent predicted FVC
Standard Deviation 10.73
|
—
|
—
|
106.5 Percent predicted FVC
Standard Deviation 7.78
|
—
|
—
|
|
Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 19: 1 hour, n=0,0,6,0,2
|
—
|
100.8 Percent predicted FVC
Standard Deviation 11.84
|
—
|
—
|
103.5 Percent predicted FVC
Standard Deviation 6.36
|
—
|
—
|
|
Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points
Day 19: 4 hours, n=0,0,6,0,2
|
—
|
101.0 Percent predicted FVC
Standard Deviation 8.88
|
—
|
—
|
101.5 Percent predicted FVC
Standard Deviation 6.36
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
FEV1 is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using standard spirometry. Percent predicted FEV1 was calculated as: Percent predicted FEV1=(maximum FEV1 divided by predicted normal FEV1)\*100.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 1: pre-dose, n=6,2,8
|
50.3 Percent predicted FEV1
Standard Deviation 13.88
|
52.4 Percent predicted FEV1
Standard Deviation 5.95
|
51.5 Percent predicted FEV1
Standard Deviation 20.51
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 1: 0.25 hour, n=6,2,8
|
45.3 Percent predicted FEV1
Standard Deviation 10.93
|
44.8 Percent predicted FEV1
Standard Deviation 4.13
|
41.0 Percent predicted FEV1
Standard Deviation 24.04
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 1: 0.5 hour, n=6,2,8
|
47.8 Percent predicted FEV1
Standard Deviation 12.45
|
47.8 Percent predicted FEV1
Standard Deviation 4.17
|
43.0 Percent predicted FEV1
Standard Deviation 24.04
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 1: 1 hour, n=6,2,8
|
50.5 Percent predicted FEV1
Standard Deviation 13.88
|
50.8 Percent predicted FEV1
Standard Deviation 2.87
|
45.0 Percent predicted FEV1
Standard Deviation 21.21
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 1: 4 hours, n=6,2,8
|
55.5 Percent predicted FEV1
Standard Deviation 12.05
|
59.0 Percent predicted FEV1
Standard Deviation 6.30
|
50.5 Percent predicted FEV1
Standard Deviation 17.68
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 3: pre-dose, n=0,0,8
|
—
|
54.9 Percent predicted FEV1
Standard Deviation 6.71
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 3: 4 hours, n=0,0,8
|
—
|
55.5 Percent predicted FEV1
Standard Deviation 6.44
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 6: pre-dose, n=0,0,8
|
—
|
54.1 Percent predicted FEV1
Standard Deviation 5.28
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 6: 4 hours, n=0,0,8
|
—
|
57.1 Percent predicted FEV1
Standard Deviation 7.57
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 11: pre-dose, n=0,0,8
|
—
|
52.4 Percent predicted FEV1
Standard Deviation 9.65
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 11: 4 hours, n=0,0,8
|
—
|
54.9 Percent predicted FEV1
Standard Deviation 8.54
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 14: pre-dose, n=0,0,8
|
—
|
51.6 Percent predicted FEV1
Standard Deviation 8.31
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 14: 0.25 hour, n=0,0,8
|
—
|
46.0 Percent predicted FEV1
Standard Deviation 9.94
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 14: 0.5 hour, n=0,0,8
|
—
|
48.1 Percent predicted FEV1
Standard Deviation 8.89
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 14: 1 hour, n=0,0,8
|
—
|
50.3 Percent predicted FEV1
Standard Deviation 8.08
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FEV1 at Indicated Time Points
Day 14: 4 hours, n=0,0,8
|
—
|
55.6 Percent predicted FEV1
Standard Deviation 6.89
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 and 14: pre-dose, 0.25, 0.5, 1 and 4 hours post-dose; Days 3, 6 and 11: pre-dose and 4 hours post-dosePopulation: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
FVC is a measure of lung function and the maximal amount of air that can be forcefully exhaled in one second. FVC was measured using standard spirometry. Percent predicted FVC was calculated as: Percent predicted FVC=(maximum FVC divided by predicted normal FVC)\*100.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 1: pre-dose, n=6,2,8
|
74.5 Percent predicted FVC
Standard Deviation 19.07
|
82.8 Percent predicted FVC
Standard Deviation 15.04
|
89.0 Percent predicted FVC
Standard Deviation 2.83
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 1: 0.25 hour, n=6,2,8
|
72.5 Percent predicted FVC
Standard Deviation 20.03
|
76.6 Percent predicted FVC
Standard Deviation 11.07
|
70.5 Percent predicted FVC
Standard Deviation 10.61
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 1: 0.5 hour, n=6,2,8
|
74.7 Percent predicted FVC
Standard Deviation 18.48
|
80.8 Percent predicted FVC
Standard Deviation 13.49
|
76.0 Percent predicted FVC
Standard Deviation 9.90
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 1: 1 hour, n=6,2,8
|
76.7 Percent predicted FVC
Standard Deviation 20.49
|
81.6 Percent predicted FVC
Standard Deviation 10.14
|
77.5 Percent predicted FVC
Standard Deviation 3.54
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 1: 4 hours, n=6,2,8
|
82.0 Percent predicted FVC
Standard Deviation 15.59
|
92.4 Percent predicted FVC
Standard Deviation 13.31
|
91.5 Percent predicted FVC
Standard Deviation 2.12
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 3: pre-dose, n=0,0,8
|
—
|
86.8 Percent predicted FVC
Standard Deviation 12.33
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 3: 4 hours, n=0,0,8
|
—
|
90.0 Percent predicted FVC
Standard Deviation 15.01
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 6: pre-dose, n=0,0,8
|
—
|
79.6 Percent predicted FVC
Standard Deviation 8.72
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 6: 4 hours, n=0,0,8
|
—
|
84.8 Percent predicted FVC
Standard Deviation 13.26
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 11: pre-dose, n=0,0,8
|
—
|
79.3 Percent predicted FVC
Standard Deviation 15.78
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 11: 4 hours, n=0,0,8
|
—
|
86.0 Percent predicted FVC
Standard Deviation 16.67
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 14: pre-dose, n=0,0,8
|
—
|
84.6 Percent predicted FVC
Standard Deviation 19.59
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 14: 0.25 hour, n=0,0,8
|
—
|
76.8 Percent predicted FVC
Standard Deviation 24.17
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 14: 0.5 hour, n=0,0,8
|
—
|
80.3 Percent predicted FVC
Standard Deviation 24.28
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 14: 1 hour, n=0,0,8
|
—
|
82.9 Percent predicted FVC
Standard Deviation 25.01
|
—
|
—
|
—
|
—
|
—
|
|
Part 2: Percent Predicted FVC at Indicated Time Points
Day 14: 4 hours, n=0,0,8
|
—
|
89.1 Percent predicted FVC
Standard Deviation 17.24
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 51 daysPopulation: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
PCI ranges for the vital signs parameters were as follows: systolic blood pressure (SBP) \<85 and \>160 millimeters of mercury (mmHg), diastolic blood pressure (DBP) \<45 and \>100 mmHg and heart rate \<40 and \>110 beats per minute (bpm). Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Vital Signs Values of PCI
DBP: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI
DBP: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI
SBP: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI
SBP: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI
Heart rate: low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI
Heart rate: high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
DBP: low
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
DBP: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
SBP: low
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
SBP: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
Heart rate: low
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders
Heart rate: high
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 46 daysPopulation: Safety Population.
PCI ranges for the vital signs parameters were as follows: SBP \<85 and \>160 mmHg, DBP \<45 and \>100 mmHg and heart rate \<40 and \>110 bpm. Data for the participants with high and low values has been reported.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Vital Signs Values of PCI
DBP: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Vital Signs Values of PCI
DBP: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Vital Signs Values of PCI
SBP: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Vital Signs Values of PCI
SBP: high
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Vital Signs Values of PCI
Heart rate: low
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 2: Number of Participants With Vital Signs Values of PCI
Heart rate: high
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the pharmacokinetics (PKs) of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data. PK population consisted of participants who received at least one dose of study treatment and who undergo plasma PK sampling and had at least one post-dose concentration result.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1
|
1255.3711 Hours*nanogram per milliliter
Geometric Coefficient of Variation 19.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-t) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3
|
3256.6746 Hours*nanogram per milliliter
Geometric Coefficient of Variation 29.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-t) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1
|
862.7642 Hours*nanogram per milliliter
Geometric Coefficient of Variation 59.1
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1
|
232.2 Nanogram per milliliter
Geometric Coefficient of Variation 20.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of Cmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3
|
507.6 Nanogram per milliliter
Geometric Coefficient of Variation 27.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of Cmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1
|
179.3 Nanogram per milliliter
Geometric Coefficient of Variation 81.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1
|
0.500 Hours
Interval 0.25 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of tmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3
|
0.625 Hours
Interval 0.25 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of tmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1
|
0.500 Hours
Interval 0.27 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1
|
1618.4216 Hours*nanogram per milliliter
Geometric Coefficient of Variation 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of AUC(0-infinity) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3
|
4418.9437 Hours*nanogram per milliliter
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of AUC(0-infinity) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=4 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1
|
968.8838 Hours*nanogram per milliliter
Geometric Coefficient of Variation 49.4
|
—
|
—
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—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1
|
25.8346 Hours
Geometric Coefficient of Variation 5.1
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of t1/2 data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3
|
41.2596 Hours
Geometric Coefficient of Variation 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of t1/2 data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=4 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1
|
16.4000 Hours
Geometric Coefficient of Variation 8.3
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24 and 48 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1
|
37.0732 Liters per hour
Geometric Coefficient of Variation 20.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 3: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 3 for the analysis of CL/F data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3
|
27.1558 Liters per hour
Geometric Coefficient of Variation 37.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Day 1 for the analysis of CL/F data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=4 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1
|
61.9269 Liters per hour
Geometric Coefficient of Variation 49.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population. NA indicates that, AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, percent AUCextrapolated (%AUCex) was \>20% in most cases. This was largely due to short period of sampling times.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of AUC(0-tau) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg
Day 6
|
NA Hours*nanogram per milliliter
Geometric Coefficient of Variation NA
AUC(0-tau) could not be calculated because t1/2 considered unreliable as period over which they were calculated was \< twice resultant t1/2 in all cases.In addition,%AUCex was \>20% in most cases.This was largely due to short period of sampling times.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg
Day 19
|
1214.2671 Hours*nanogram per milliliter
Geometric Coefficient of Variation 21.1
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Day 1, n=12
|
564.7314 Hours*nanogram per milliliter
Geometric Coefficient of Variation 50.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Day 14, n=8
|
2059.8983 Hours*nanogram per milliliter
Geometric Coefficient of Variation 15.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 and 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of AUC(0-tau) data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Day 1, n=8
|
687.0875 Hours*nanogram per milliliter
Geometric Coefficient of Variation 39.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg
Day 14, n=7
|
3086.5172 Hours*nanogram per milliliter
Geometric Coefficient of Variation 28.1
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of Cmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg
Day 6
|
143.1 Nanogram per milliliter
Geometric Coefficient of Variation 23.2
|
—
|
—
|
—
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—
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—
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—
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|
Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg
Day 19
|
193.9 Nanogram per milliliter
Geometric Coefficient of Variation 15.1
|
—
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—
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—
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—
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—
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—
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PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Day 1, n=12
|
188.7 Nanogram per milliliter
Geometric Coefficient of Variation 63.5
|
—
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—
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—
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—
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—
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—
|
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Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Day 14, n=11
|
285.0 Nanogram per milliliter
Geometric Coefficient of Variation 39.0
|
—
|
—
|
—
|
—
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—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the indicated time points were analyzed.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of Cmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Day 1
|
178.2 Nanogram per milliliter
Geometric Coefficient of Variation 51.4
|
—
|
—
|
—
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—
|
—
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—
|
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Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg
Day 14
|
423.0 Nanogram per milliliter
Geometric Coefficient of Variation 31.9
|
—
|
—
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—
|
—
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—
|
—
|
PRIMARY outcome
Timeframe: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of tmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg
Day 19
|
0.500 Hours
Interval 0.25 to 0.5
|
—
|
—
|
—
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—
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—
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—
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|
Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg
Day 6
|
0.500 Hours
Interval 0.5 to 0.75
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Day 1, n=12
|
0.633 Hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Day 14, n=11
|
0.500 Hours
Interval 0.3 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of tmax data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Day 1
|
0.633 Hours
Interval 0.25 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg
Day 14
|
0.500 Hours
Interval 0.25 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 6: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 19: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours post-dosePopulation: PK Population. NA indicates that, t1/2 of CCI15106 plasma concentration in healthy participant was estimated but considered unreliable as period over which they were calculated was less than twice resultant t1/2 in all cases. In addition, %AUCex was \>20% in most cases. This was largely due to short period of sampling times.
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 6 and 19 for the analysis of t1/2 data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg
Day 6
|
NA Hours
Geometric Coefficient of Variation NA
t1/2 of CCI15106 plasma concentration was estimated but considered unreliable as period over which they were calculated was \< twice resultant t1/2 in all cases.%AUCex was \>20% in most cases.This was largely due to short period of sampling times.
|
—
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—
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—
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—
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—
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—
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|
Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg
Day 19
|
18.1484 Hours
Geometric Coefficient of Variation 10.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day 14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Day 1, n=12
|
8.3719 Hours
Geometric Coefficient of Variation 14.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Day 14, n=8
|
23.0497 Hours
Geometric Coefficient of Variation 42.4
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10 and 12 hours post-dose; Day14: pre-dose, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, 12 and 24 hours post-dosePopulation: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected to evaluate the PKs of CCI15106 at the indicated time points on Days 1 and 14 for the analysis of t1/2 data.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Day 1, n=8
|
8.1572 Hours
Geometric Coefficient of Variation 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg
Day 14, n=7
|
21.5034 Hours
Geometric Coefficient of Variation 39.6
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14: pre-dose, 15 minutes post-dosePopulation: Bystander PK Population. NA indicates that, data could not be analyzed because data was below level of quantification.
Blood samples were collected from bystanders 15 minutes after dosing at indicated time points. Bystander PK population consisted of participants who were present at least once in the room with the participant receiving the dose, undergo plasma PK sampling and had post-dose concentration result.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=14 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C
|
NA Nanogram per milliliter
Standard Deviation NA
Data could not be analyzed because data was below level of quantification.
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14: 15 minutes post-dosePopulation: Bystander PK Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Personal exposure air samples were collected on filters placed on each bystander after the first daily dose at indicated time points. The filters were used to measure CCI15106 concentration in the person's breathing zone. Fixed location concentrations were measured near window, near door, back to wall and facing wall in the dosing room over 15 minutes post-dose. Each bystander had a filter attached to their study clothing. The filters were measured for CCI15106. This was a single measurement from the filter for each bystsander. The locations (near window, near door, back to wall and facing wall) were just to record where the bystander was located in the room.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=2 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=2 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=2 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=2 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
n=2 Participants
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
n=2 Participants
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 1: Near door,n=1,1,1,1,0,0,0
|
0.53 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.81 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.39 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
8.99 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 1: Near window,n=1,1,1,1,0,0,0
|
1.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.46 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
4.84 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 1: Back to wall,n=0,0,0,0,1,1,1
|
—
|
—
|
—
|
—
|
5.27 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 1: Facing wall,n=0,0,0,0,1,1,1
|
—
|
—
|
—
|
—
|
5.84 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 7: Near door,n=1,1,1,1,0,0,0
|
2.81 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.13 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.62 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.49 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 7: Near window,n=1,1,1,1,0,0,0
|
2.86 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
3.14 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.74 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.41 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 7: Back to wall,n=0,0,0,0,1,1,1
|
—
|
—
|
—
|
—
|
0.76 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.47 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.80 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 7: Facing wall,n=0,0,0,0,1,1,1
|
—
|
—
|
—
|
—
|
0.86 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.00 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 14: Near door,n=1,1,1,1,0,0,0
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
9.22 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.97 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 14: Near window,n=1,1,1,1,0,0,0
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
8.09 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.73 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.45 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
—
|
—
|
—
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 14: Back to wall,n=0,0,0,0,1,1,1
|
—
|
—
|
—
|
—
|
0.38 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.35 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C
Day 14: Facing wall,n=0,0,0,0,1,1,1
|
—
|
—
|
—
|
—
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
PRIMARY outcome
Timeframe: Days 1, 7 and 14: 20 and 60 minutes post-dosePopulation: Bystander PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Static air samples were collected on filters within air pumps positioned in two locations (bench and corner) in the room. Sampling devices attached to sampling pumps were used to measure CCI15106 concentration. Fixed location concentrations were measured in corner of room and on bench at back of room over 20 minutes and 60 minutes post-dosing.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=2 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=2 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=2 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=2 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=2 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
n=2 Participants
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
n=2 Participants
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 1: 20 minutes- Corner,n=1,1,1,1,1,1,1
|
0.79 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.09 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
4.12 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
5.80 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 1: 20 minutes- Bench,n=1,1,1,1,1,1,1
|
1.46 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.58 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
3.74 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
4.98 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 7: 20 minutes- Corner,n=1,1,1,1,1,1,1
|
1.52 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.64 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.53 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.30 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.30 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.28 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.01 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 7: 20 minutes- Bench,n=1,1,1,1,1,1,1
|
2.39 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.34 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
3.32 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.46 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.65 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.13 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 14: 20 minutes- Corner,n=1,1,1,1,1,1,1
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
8.54 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.87 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.36 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.30 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 14: 20 minutes- Bench,n=1,1,1,1,1,1,1
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
6.47 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.39 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.27 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.50 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 1: 60 minutes- Corner,n=1,1,1,1,1,1,1
|
0.89 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.99 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.13 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.03 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.34 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 1: 60 minutes- Bench,n=1,1,1,1,1,1,1
|
0.75 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.90 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.15 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.09 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
2.17 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 7: 60 minutes- Corner,n=1,1,1,1,1,1,1
|
0.22 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.19 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.72 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.19 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.34 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.46 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 7: 60 minutes- Bench,n=1,1,1,1,1,1,1
|
1.22 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.00 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
1.40 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.18 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.28 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.52 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 14: 60 minutes- Corner,n=1,1,1,1,1,1,1
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
3.58 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.70 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.14 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
|
Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C
Day 14: 60 minutes- Bench,n=1,1,1,1,1,1,1
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
3.20 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.62 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.14 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.11 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
0.10 Microgram per cubic meter
Standard Deviation NA
Standard deviation could not be calculated for one participant.
|
SECONDARY outcome
Timeframe: Up to Day 13Population: BAL PK Population.
Bronchoalveolar lavage samples for ELF concentration analysis of CCI15106 were collected up to Day 13. Participants who received at least one dose of study treatment and who underwent bronchoalveolar lavage (BAL) sampling and had post-dose lung ELF CCI15106 and urea concentration result were included in BAL PK Population.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=12 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg
|
47306.383 Nanogram per milliliter
Standard Deviation 25231.0613
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 13Population: BAL PK Population.
BAL samples for ELF concentration analysis of CCI15106 were collected up to Day 13.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=8 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg
|
247290.327 Nanogram per milliliter
Standard Deviation 427471.7407
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 19Population: Safety Population. The primary aim was to compare the safety profiles of the different active doses; hence, placebo arms have been combined as pre-specified in reporting and analysis plan.
A medical device incident is any malfunction or deterioration in the characteristics and/or performance of a device as well as any inadequacy in the labeling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a participant/user/other person or to a serious deterioration in his/her state of health.
Outcome measures
| Measure |
Part 2: Cohort A- CCI15106 60 mg SD
n=6 Participants
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=6 Participants
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 Participants
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 Participants
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Placebo
n=4 Participants
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A; further followed by a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Bystander Group 4- Session 1
Participants inhaled the dose of CCI15106 60 mg or matching placebo BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 1 on Days 1, 7 and 14.
|
Part 1: Bystander Group 4- Session 2
Participants inhaled the dose of CCI15106 60 mg BID via Monodose RS01 in a room designated for dosing. Only participants inhaled the dose and designated bystanders (healthy participants enrolled to evaluate bystander exposure) were allowed in the room during inhalation of the airborne drug in session 2 on Days 1, 7 and 14.
|
|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Medical Device Incidents in CCI15106
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
Adverse Events
Part 1: Cohort A- CCI15106 60 mg SD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort A- CCI15106 120 mg SD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort A- CCI15106 30 mg BID
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort A- Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort B- CCI15106 60 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 1: Cohort B- Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: Cohort C- Bystanders
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part 2: Cohort A- CCI15106 60 mg SD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Cohort A- Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Cohort B- CCI15106 60 mg BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Cohort A- CCI15106 60 mg SD
n=6 participants at risk
Healthy participants were administered a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 120 mg SD
n=6 participants at risk
Healthy participants were administered a SD of CCI15106 120 mg by inhalation route on Day 3 via Monodose RS01.
|
Part 1: Cohort A- CCI15106 30 mg BID
n=6 participants at risk
Healthy participants were administered a BID dose of CCI15106 30 mg by inhalation route on Days 6 to 19 via Monodose RS01.
|
Part 1: Cohort A- Placebo
n=2 participants at risk
Healthy participants were administered a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01; followed by a SD matching placebo 120 mg by inhalation route on Day 3 via Monodose RS01; further followed by a BID dose of matching placebo 30 mg by inhalation route on Days 6 to 19 via Monodose RS01 in cohort A.
|
Part 1: Cohort B- CCI15106 60 mg BID
n=12 participants at risk
Healthy participants were administered with a BID dose of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
Part 1: Cohort B- Placebo
n=2 participants at risk
Healthy participants were administered with a BID dose of matching placebo 60 mg by inhalation route on Days 1 to 14 via Monodose RS01 in cohort B.
|
Part 1: Cohort C- Bystanders
n=14 participants at risk
Healthy participants were enrolled to evaluate bystander exposure and evaluated concomitantly with Cohort B. Bystanders reported to the unit on Day -1 and remained for 14 days of dosing of Cohort B.
|
Part 2: Cohort A- CCI15106 60 mg SD
n=6 participants at risk
Participants with COPD received a SD of CCI15106 60 mg by inhalation route on Day 1 via Monodose RS01.
|
Part 2: Cohort A- Placebo
n=2 participants at risk
Participants with COPD received a SD of matching placebo 60 mg by inhalation route on Day 1 via Monodose RS01 in Cohort A.
|
Part 2: Cohort B- CCI15106 60 mg BID
n=8 participants at risk
Participants with COPD received a BID of CCI15106 60 mg by inhalation route on Days 1 to 14 via Monodose RS01.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Malaise
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
25.0%
3/12 • Number of events 3 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
16.7%
2/12 • Number of events 2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
25.0%
3/12 • Number of events 3 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
28.6%
4/14 • Number of events 4 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
16.7%
2/12 • Number of events 2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/14 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
12.5%
1/8 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
14.3%
2/14 • Number of events 2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/12 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
7.1%
1/14 • Number of events 1 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/6 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/2 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
0.00%
0/8 • AEs and SAEs were collected up to 51 days for Cohort A in Part 1, 46 days for Cohorts B and C in Part 1; 33 days for Cohort A in Part 2 and 46 days for Cohort B in Part 2
Safety population was used to assess NSAEs and SAEs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER