Trial Outcomes & Findings for Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (NCT NCT05616221)
NCT ID: NCT05616221
Last Updated: 2026-01-05
Results Overview
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 17
Results posted on
2026-01-05
Participant Flow
Participant milestones
| Measure |
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
Subjects receive AP-PA02
|
Cohort A: AP-PA02, 3x10^11 PFU/Dose
Subjects receive AP-PA02
|
Cohort A: Placebo
Subjects receive placebo
|
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: AP-PA02, 3x10^11 PFU/Dose
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: Placebo
Subjects receive placebo plus inhaled antibiotic
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
19
|
12
|
1
|
9
|
3
|
|
Overall Study
COMPLETED
|
4
|
16
|
12
|
1
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
Subjects receive AP-PA02
|
Cohort A: AP-PA02, 3x10^11 PFU/Dose
Subjects receive AP-PA02
|
Cohort A: Placebo
Subjects receive placebo
|
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: AP-PA02, 3x10^11 PFU/Dose
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: Placebo
Subjects receive placebo plus inhaled antibiotic
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
2
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
Baseline characteristics by cohort
| Measure |
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
n=4 Participants
Subjects receive AP-PA02
|
Cohort A: AP-PA02, 3x10^11 PFU/Dose
n=19 Participants
Subjects receive AP-PA02
|
Cohort A: Placebo
n=12 Participants
Subjects receive placebo
|
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
n=1 Participants
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: AP-PA02, 3x10^11 PFU/Dose
n=9 Participants
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: Placebo
n=3 Participants
Subjects receive placebo plus inhaled antibiotic
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 7.85 • n=9667 Participants
|
60.9 years
STANDARD_DEVIATION 16.26 • n=6597 Participants
|
71.7 years
STANDARD_DEVIATION 11.02 • n=16264 Participants
|
75.0 years
STANDARD_DEVIATION 0 • n=31 Participants
|
64.1 years
STANDARD_DEVIATION 16.24 • n=21 Participants
|
53.7 years
STANDARD_DEVIATION 28.43 • n=3 Participants
|
64.5 years
STANDARD_DEVIATION 15.53 • n=6 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9667 Participants
|
15 Participants
n=6597 Participants
|
8 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=3 Participants
|
36 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=9667 Participants
|
4 Participants
n=6597 Participants
|
4 Participants
n=16264 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9667 Participants
|
1 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=9667 Participants
|
17 Participants
n=6597 Participants
|
11 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=3 Participants
|
41 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
0 Participants
n=16264 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9667 Participants
|
0 Participants
n=6597 Participants
|
1 Participants
n=16264 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 17Population: According to the Statistical Analysis Plan, participants who enrolled before the first DSMB meeting received a lower dose of AP-PA02 (1.5×10¹¹ PFU) and were not included in the primary analysis. In addition, two participants were excluded due to major protocol deviations related to study drug compliance. After applying these prespecified criteria, 41 participants were included in the primary outcome analysis.
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
Outcome measures
| Measure |
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
Subjects receive AP-PA02
|
Cohort A: AP-PA02, 3x10^11 PFU/Dose
n=18 Participants
Subjects receive AP-PA02
|
Cohort A: Placebo
n=12 Participants
Subjects receive placebo
|
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: AP-PA02, 3x10^11 PFU/Dose
n=8 Participants
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: Placebo
n=3 Participants
Subjects receive placebo plus inhaled antibiotic
|
|---|---|---|---|---|---|---|
|
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
|
—
|
-0.5 colony forming units log10
Standard Deviation 0.72
|
-0.1 colony forming units log10
Standard Deviation 1.11
|
—
|
-0.4 colony forming units log10
Standard Deviation 1.63
|
1.0 colony forming units log10
Standard Deviation 1.13
|
POST_HOC outcome
Timeframe: Day 17Population: Post hoc analysis included all enrolled subjects, regardless of dose level or protocol deviations.
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
Outcome measures
| Measure |
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
n=33 Participants
Subjects receive AP-PA02
|
Cohort A: AP-PA02, 3x10^11 PFU/Dose
n=15 Participants
Subjects receive AP-PA02
|
Cohort A: Placebo
Subjects receive placebo
|
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: AP-PA02, 3x10^11 PFU/Dose
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: Placebo
Subjects receive placebo plus inhaled antibiotic
|
|---|---|---|---|---|---|---|
|
Post Hoc, Pooled Analysis: P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
|
-0.6 colony forming units log10
Standard Deviation 0.93
|
0.1 colony forming units log10
Standard Deviation 1.17
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort A: AP-PA02, 3x10^11 PFU/Dose
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort A: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B: AP-PA02, 3x10^11 PFU/Dose
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort B: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
n=4 participants at risk
Subjects receive AP-PA02
|
Cohort A: AP-PA02, 3x10^11 PFU/Dose
n=19 participants at risk
Subjects receive AP-PA02
|
Cohort A: Placebo
n=12 participants at risk
Subjects receive placebo
|
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
n=1 participants at risk
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: AP-PA02, 3x10^11 PFU/Dose
n=9 participants at risk
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: Placebo
n=3 participants at risk
Subjects receive placebo plus inhaled antibiotic
|
|---|---|---|---|---|---|---|
|
Infections and infestations
urinary tract infection
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
22.2%
2/9 • Number of events 2 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
Other adverse events
| Measure |
Cohort A: AP-PA02, 1.5x10^11 PFU/Dose
n=4 participants at risk
Subjects receive AP-PA02
|
Cohort A: AP-PA02, 3x10^11 PFU/Dose
n=19 participants at risk
Subjects receive AP-PA02
|
Cohort A: Placebo
n=12 participants at risk
Subjects receive placebo
|
Cohort B: AP-PA02, 1.5x10^11 PFU/Dose
n=1 participants at risk
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: AP-PA02, 3x10^11 PFU/Dose
n=9 participants at risk
Subjects receive AP-PA02 plus inhaled antibiotic
|
Cohort B: Placebo
n=3 participants at risk
Subjects receive placebo plus inhaled antibiotic
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
General disorders
Pyrexia
|
0.00%
0/4 • 38 Days
|
15.8%
3/19 • Number of events 3 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
22.2%
2/9 • Number of events 2 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
General disorders
Chills
|
0.00%
0/4 • 38 Days
|
10.5%
2/19 • Number of events 2 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
General disorders
Axillary pain
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
General disorders
Chest pain
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Infections and infestations
Pneumonia bacterial
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Infections and infestations
Pyuria
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
33.3%
1/3 • Number of events 1 • 38 Days
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Infections and infestations
Sputum purulent
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
25.0%
1/4 • Number of events 1 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Investigations
Blood creatine phosphokinase increased
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Investigations
Pulmonary function test decreased
|
25.0%
1/4 • Number of events 1 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/4 • 38 Days
|
15.8%
3/19 • Number of events 3 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
25.0%
1/4 • Number of events 1 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • 38 Days
|
5.3%
1/19 • Number of events 1 • 38 Days
|
8.3%
1/12 • Number of events 1 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • 38 Days
|
0.00%
0/19 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
11.1%
1/9 • Number of events 1 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/4 • 38 Days
|
10.5%
2/19 • Number of events 2 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
22.2%
2/9 • Number of events 2 • 38 Days
|
0.00%
0/3 • 38 Days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
2/4 • Number of events 2 • 38 Days
|
10.5%
2/19 • Number of events 2 • 38 Days
|
0.00%
0/12 • 38 Days
|
0.00%
0/1 • 38 Days
|
0.00%
0/9 • 38 Days
|
0.00%
0/3 • 38 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place