Trial Outcomes & Findings for Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis (NCT NCT06041919)
NCT ID: NCT06041919
Last Updated: 2025-07-15
Results Overview
Overnight sputum collection from which viable mycobacteria in the sample is quantified as TTP Observed EBA for 0-2, 0-7, 0-14, 0-15 and 14-15 days in TTP (hours) for treatment in each of the treatment groups
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
0-2, 0-7, 0-14, 0-15 and 14-15 days
Results posted on
2025-07-15
Participant Flow
Participant milestones
| Measure |
1 (Active)
Inhaled RESP301 6ml via nebulisation three times daily
RESP301: Nitric Oxide agent
|
2 (Control)
HRZE taken orally once daily
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
RESP301: Nitric Oxide agent
|
4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
RESP301: Nitric Oxide agent
|
5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once daily
RESP301: Nitric Oxide agent
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
14
|
4
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
1 (Active)
Inhaled RESP301 6ml via nebulisation three times daily
RESP301: Nitric Oxide agent
|
2 (Control)
HRZE taken orally once daily
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
RESP301: Nitric Oxide agent
|
4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
RESP301: Nitric Oxide agent
|
5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once daily
RESP301: Nitric Oxide agent
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
At the request of the investigator or the sponsor
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Evaluating the Early Bactericidal Activity, Safety and Tolerability of Nebulised RESP301 in Adults With Tuberculosis
Baseline characteristics by cohort
| Measure |
1 (Active)
n=15 Participants
Inhaled RESP301 6ml via nebulisation three times daily
RESP301: Nitric Oxide agent
|
2 (Control)
n=5 Participants
HRZE taken orally once daily
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
RESP301: Nitric Oxide agent
|
4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
RESP301: Nitric Oxide agent
|
5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once daily
RESP301: Nitric Oxide agent
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.00 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
31.20 years
STANDARD_DEVIATION 5.93 • n=7 Participants
|
—
|
—
|
—
|
31.05 years
STANDARD_DEVIATION 9.08 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
—
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
—
|
—
|
17 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
—
|
—
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
—
|
0 Participants
n=8 Participants
|
|
Weight
|
53.05 kg
STANDARD_DEVIATION 9.83 • n=5 Participants
|
50.08 kg
STANDARD_DEVIATION 6.76 • n=7 Participants
|
—
|
—
|
—
|
52.31 kg
STANDARD_DEVIATION 8.85 • n=8 Participants
|
|
Height
|
1.69 m
STANDARD_DEVIATION 0.07 • n=5 Participants
|
1.65 m
STANDARD_DEVIATION 0.05 • n=7 Participants
|
—
|
—
|
—
|
1.68 m
STANDARD_DEVIATION 0.07 • n=8 Participants
|
|
BMI
|
18.70 kg/m^2
STANDARD_DEVIATION 3.58 • n=5 Participants
|
18.34 kg/m^2
STANDARD_DEVIATION 1.70 • n=7 Participants
|
—
|
—
|
—
|
18.61 kg/m^2
STANDARD_DEVIATION 3.17 • n=8 Participants
|
PRIMARY outcome
Timeframe: 0-2, 0-7, 0-14, 0-15 and 14-15 daysPopulation: Decision was made by the sponsor not to progress to Stage 2
Overnight sputum collection from which viable mycobacteria in the sample is quantified as TTP Observed EBA for 0-2, 0-7, 0-14, 0-15 and 14-15 days in TTP (hours) for treatment in each of the treatment groups
Outcome measures
| Measure |
1 (Active)
n=15 Participants
Inhaled RESP301 6ml via nebulisation three times daily
RESP301: Nitric Oxide agent
|
2 (Control)
n=5 Participants
HRZE taken orally once daily
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
RESP301: Nitric Oxide agent
|
4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
RESP301: Nitric Oxide agent
|
5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once daily
RESP301: Nitric Oxide agent
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Time to Positivity (TTP)
0-14
|
2.5 Hours
Interval -7.8 to 9.1
|
167.8 Hours
Interval 147.8 to 200.5
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Time to Positivity (TTP)
0-2
|
3.5 Hours
Interval -5.2 to 5.6
|
63.5 Hours
Interval 53.2 to 78.2
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Time to Positivity (TTP)
0-7
|
2 Hours
Interval -6.9 to 15.0
|
140.2 Hours
Interval 117.0 to 160.0
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Time to Positivity (TTP)
0-15
|
6.2 Hours
Interval -8.0 to 16.1
|
225 Hours
Interval 157.8 to 247.5
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Time to Positivity (TTP)
14-15
|
7.5 Hours
Interval -3.0 to 17.5
|
2 Hours
Interval -5.0 to 47.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-2, 0-7, 0-14, 0-15 and 14-15 daysPopulation: Decision was made by the sponsor not to progress to Stage 2
Overnight sputum collection from which viable mycobacteria in the sample is quantified as CFU Observed EBA for 0-2, 0-7, 0-14, 0-15 and 14-15 days in CFU (Log10 CFU/mL) for treatment in each of the treatment groups
Outcome measures
| Measure |
1 (Active)
n=15 Participants
Inhaled RESP301 6ml via nebulisation three times daily
RESP301: Nitric Oxide agent
|
2 (Control)
n=5 Participants
HRZE taken orally once daily
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
RESP301: Nitric Oxide agent
|
4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
RESP301: Nitric Oxide agent
|
5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once daily
RESP301: Nitric Oxide agent
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
|---|---|---|---|---|---|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Colony Forming Units (CFU)
0-2
|
0.3 Log10 CFU/mL
Interval -0.1 to 0.5
|
-0.9 Log10 CFU/mL
Interval -0.9 to -0.6
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Colony Forming Units (CFU)
0-7
|
0.2 Log10 CFU/mL
Interval -0.2 to 0.4
|
-1.2 Log10 CFU/mL
Interval -1.6 to -0.8
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Colony Forming Units (CFU)
0-14
|
0.4 Log10 CFU/mL
Interval -0.2 to 0.8
|
-2.9 Log10 CFU/mL
Interval -3.1 to -2.7
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Colony Forming Units (CFU)
0-15
|
0.3 Log10 CFU/mL
Interval -0.4 to 0.7
|
-2.4 Log10 CFU/mL
Interval -3.6 to -1.4
|
—
|
—
|
—
|
|
Early Bactericidal Activity (EBA) of Inhaled RESP301 Measured as Colony Forming Units (CFU)
14-15
|
0 Log10 CFU/mL
Interval -0.3 to 0.1
|
0.1 Log10 CFU/mL
Interval 0.1 to 0.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study terminationPopulation: Decision was made by the sponsor not to progress to Stage 2
Incidence of Treatment Emergent Adverse Events (TEAEs) will be presented by severity, drug relatedness, seriousness, leading to early withdrawal and leading to death.
Outcome measures
| Measure |
1 (Active)
n=15 Participants
Inhaled RESP301 6ml via nebulisation three times daily
RESP301: Nitric Oxide agent
|
2 (Control)
n=5 Participants
HRZE taken orally once daily
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
RESP301: Nitric Oxide agent
|
4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
RESP301: Nitric Oxide agent
|
5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once daily
RESP301: Nitric Oxide agent
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
|---|---|---|---|---|---|
|
Safety and Tolerability of Inhaled RESP301 Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Number of Grade 1 (Mild) TEAEs
|
38 events
|
7 events
|
—
|
—
|
—
|
|
Safety and Tolerability of Inhaled RESP301 Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Number of Grade 2 (Moderate) TEAEs
|
13 events
|
2 events
|
—
|
—
|
—
|
|
Safety and Tolerability of Inhaled RESP301 Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Number of Grade 3 (Severe) TEAEs
|
2 events
|
0 events
|
—
|
—
|
—
|
|
Safety and Tolerability of Inhaled RESP301 Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Number of Grade 4 (Life-threatening) TEAEs
|
0 events
|
0 events
|
—
|
—
|
—
|
|
Safety and Tolerability of Inhaled RESP301 Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Number of Unrelated TEAEs
|
27 events
|
8 events
|
—
|
—
|
—
|
|
Safety and Tolerability of Inhaled RESP301 Measured as Number of Treatment Emergent Adverse Events (TEAEs)
Number of Related TEAEs
|
26 events
|
1 events
|
—
|
—
|
—
|
Adverse Events
1 (Active)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
2 (Control)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
3 (Active)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4 (Active)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
5 (Active)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 (Active)
n=15 participants at risk
Inhaled RESP301 6ml via nebulisation three times daily
RESP301: Nitric Oxide agent
|
2 (Control)
n=5 participants at risk
HRZE taken orally once daily
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
3 (Active)
Inhaled RESP301 6 ml via nebulisation once daily
RESP301: Nitric Oxide agent
|
4 (Active)
Inhaled RESP301 6 ml via nebulisation twice daily
RESP301: Nitric Oxide agent
|
5 (Active)
Inhaled RESP301 6 ml via nebulisation three times daily plus HRZE taken orally once daily
RESP301: Nitric Oxide agent
HRZE: isoniazid 75 mg (H), rifampicin 150 mg (R), pyrazinamide 400 mg (Z), ethambutol 275 mg (E)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
13.3%
2/15 • Number of events 2 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Gastrointestinal disorders
Post-Tussive Vomiting
|
6.7%
1/15 • Number of events 2 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Infections and infestations
Herpes Simplex
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Infections and infestations
Otitis Media
|
0.00%
0/15 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/15 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
13.3%
2/15 • Number of events 3 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Investigations
Weight Decreased
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.3%
2/15 • Number of events 2 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Musculoskeletal and connective tissue disorders
costcochondritis
|
0.00%
0/15 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Nervous system disorders
Insomnia
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Nervous system disorders
Somnolence
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
40.0%
6/15 • Number of events 6 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Respiratory, thoracic and mediastinal disorders
Chest Discomfort
|
0.00%
0/15 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
86.7%
13/15 • Number of events 17 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
0.00%
0/5 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15 • Number of events 2 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
20.0%
1/5 • Number of events 1 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
—
0/0 • Stage 1: Dosing period 14 days + Follow-up period 14 days. Stage 2: Participants did not enter the treatment phase due to early study termination
Stage 2 (Arm 3,4, and 5): Participants did not enter the treatment phase due to early study termination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place