Trial Outcomes & Findings for Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics (NCT NCT05448651)
NCT ID: NCT05448651
Last Updated: 2025-01-03
Results Overview
Overall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline through 24 weeks
Results posted on
2025-01-03
Participant Flow
The study was conducted in 4 sites in the United Kingdom (UK).
Participant milestones
| Measure |
Active Substance 1
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
UPB-101 Cohort 4 (25 mg)
|
Placebo
Placebo: Subcutaneous injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Biologic Impact (Pharmacodynamics) of Repeated Injections and Increasing Amounts of UPB-101 in Asthmatics
Baseline characteristics by cohort
| Measure |
Active Substance 1
n=6 Participants
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
n=6 Participants
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
n=6 Participants
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
n=6 Participants
UPB-101 Cohort 4 (25 mg)
|
Placebo
n=8 Participants
Placebo: Subcutaneous injection
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 8.82 • n=7 Participants
|
32.7 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 5.25 • n=4 Participants
|
37.0 years
STANDARD_DEVIATION 11.41 • n=21 Participants
|
38.1 years
STANDARD_DEVIATION 10.22 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 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=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 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=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
32 participants
n=8 Participants
|
|
BMI at Screening (kg/m2)
|
26.57 kg/m^2
STANDARD_DEVIATION 3.025 • n=5 Participants
|
25.18 kg/m^2
STANDARD_DEVIATION 2.074 • n=7 Participants
|
25.22 kg/m^2
STANDARD_DEVIATION 2.848 • n=5 Participants
|
27.65 kg/m^2
STANDARD_DEVIATION 2.518 • n=4 Participants
|
25.56 kg/m^2
STANDARD_DEVIATION 3.110 • n=21 Participants
|
26.01 kg/m^2
STANDARD_DEVIATION 2.784 • n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through 24 weeksOverall Summary of Treatment-emergent Adverse Events (TEAEs) and Adverse Events (AEs) up to Week 24 (Safety Population)
Outcome measures
| Measure |
Active Substance 1
n=6 Participants
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
n=6 Participants
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
n=6 Participants
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
n=6 Participants
UPB-101 Cohort 4 (25 mg)
|
Placebo
n=8 Participants
Placebo: Subcutaneous injection
|
|---|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events and Serious Adverse Events
any TEAEs
|
19 adverse events
|
17 adverse events
|
12 adverse events
|
9 adverse events
|
25 adverse events
|
|
Number of Treatment-emergent Adverse Events and Serious Adverse Events
SAEs
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: Baseline through Week 32Population: Subjects who received any kind of study intervention, and had at least one blood sample measured for ADAs.
Blood samples were analyzed for the presence of ADAs using validated assays. Low titer ADA responses were detected toward the end of the concentration vs time profile. There was no evident effect of ADAs on drug exposure and no immune-related adverse events
Outcome measures
| Measure |
Active Substance 1
n=6 Participants
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
n=6 Participants
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
n=6 Participants
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
n=6 Participants
UPB-101 Cohort 4 (25 mg)
|
Placebo
n=8 Participants
Placebo: Subcutaneous injection
|
|---|---|---|---|---|---|
|
Incidence of Anti-drug Antibodies
|
4 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First Dose = Day 1. Last Dose = Baseline through 32 weeks.Population: The PK Population included all subjects who received at least 1 complete dose of active study drug (UPB-101) and for whom at least 1 PK parameter was estimated.
Blood samples were collected and analyzed using a validated assay to determine the Cmax (ug/mL) of UPB-101. The pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Outcome measures
| Measure |
Active Substance 1
n=6 Participants
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
n=6 Participants
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
n=6 Participants
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
n=6 Participants
UPB-101 Cohort 4 (25 mg)
|
Placebo
Placebo: Subcutaneous injection
|
|---|---|---|---|---|---|
|
Maximum Observed Concentration of UPB-101
Cmax after first dose
|
8.82 ug/mL
Standard Deviation 2.25
|
21.8 ug/mL
Standard Deviation 3.78
|
32.4 ug/mL
Standard Deviation 6.23
|
1.85 ug/mL
Standard Deviation 0.602
|
—
|
|
Maximum Observed Concentration of UPB-101
Cmax after last dose
|
16.3 ug/mL
Standard Deviation 5.03
|
41.8 ug/mL
Standard Deviation 5.69
|
33.8 ug/mL
Standard Deviation 8.39
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 32 weeksPopulation: The PK Population included all subjects who received at least 1 complete dose of active study drug (UPB-101) and for whom at least 1 PK parameter was estimated.
Blood samples were collected and analyzed using a validated assay to determine the Tmax (days) of UPB-101. The pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Outcome measures
| Measure |
Active Substance 1
n=6 Participants
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
n=6 Participants
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
n=6 Participants
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
n=6 Participants
UPB-101 Cohort 4 (25 mg)
|
Placebo
Placebo: Subcutaneous injection
|
|---|---|---|---|---|---|
|
Time to Maximum Observed Concentration of UPB-101
Tmax after first dose
|
6.98 days
Interval 2.92 to 14.0
|
5.95 days
Interval 2.77 to 13.9
|
6.93 days
Interval 5.93 to 6.98
|
9.94 days
Interval 2.9 to 20.9
|
—
|
|
Time to Maximum Observed Concentration of UPB-101
Tmax after last dose
|
5.00 days
Interval 2.99 to 7.04
|
3.94 days
Interval 2.9 to 6.91
|
4.98 days
Interval 2.91 to 13.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 32 weeksPopulation: The PK Population included all subjects who received at least 1 complete dose of active study drug (UPB-101) and for whom at least 1 PK parameter was estimated.
Blood samples were collected and analyzed using a validated assay to determine the AUClast (d.ug/mL) of UPB-101. The pharmacokinetic (PK) parameters were estimated using non-compartmental analysis.
Outcome measures
| Measure |
Active Substance 1
n=6 Participants
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
n=6 Participants
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
n=6 Participants
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
n=6 Participants
UPB-101 Cohort 4 (25 mg)
|
Placebo
Placebo: Subcutaneous injection
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve Under One Dosing Interval of UPB-101
AUClast after the first dose
|
187 day*μg/mL
Standard Deviation 40.8
|
449 day*μg/mL
Standard Deviation 101
|
1220 day*μg/mL
Standard Deviation 236
|
73.4 day*μg/mL
Standard Deviation 26.6
|
—
|
|
Area Under the Concentration-time Curve Under One Dosing Interval of UPB-101
AUClast after the last dose
|
613 day*μg/mL
Standard Deviation 115
|
1740 day*μg/mL
Standard Deviation 496
|
1420 day*μg/mL
Standard Deviation 453
|
—
|
—
|
Adverse Events
Active Substance 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active Substance 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Active Substance 3
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Active Substance 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Substance 1
n=6 participants at risk
UPB-101 Cohort 1 (100 mg)
|
Active Substance 2
n=6 participants at risk
UPB-101 Cohort 2 (200 mg)
|
Active Substance 3
n=6 participants at risk
UPB-101 Cohort 3 (300 mg)
|
Active Substance 4
n=6 participants at risk
UPB-101 Cohort 4 (25 mg)
|
Placebo
n=8 participants at risk
Placebo: Subcutaneous injection
|
|---|---|---|---|---|---|
|
Infections and infestations
Rhinitis
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
33.3%
2/6 • Number of events 3 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
37.5%
3/8 • Number of events 3 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
33.3%
2/6 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
25.0%
2/8 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
33.3%
2/6 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
Ear infection
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
Lower respiratory tract infection
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
Tinea infection
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
25.0%
2/8 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
25.0%
2/8 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 5 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
33.3%
2/6 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
33.3%
2/6 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Nervous system disorders
Migraine
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
25.0%
2/8 • Number of events 2 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Investigations
Heart rate increased
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
12.5%
1/8 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
16.7%
1/6 • Number of events 1 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/6 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
0.00%
0/8 • 24 weeks
Treatment-emergent Adverse Events Reported by at Least 5% of Participants Overall up to Week 24 (Safety Population)
|
Additional Information
Sumathi Sivapalasingam, Vice President of Clinical Development
Upstream Bio
Phone: 917-499-0789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place