Trial Outcomes & Findings for SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion (NCT NCT04631666)
NCT ID: NCT04631666
Last Updated: 2024-04-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
57 participants
Primary outcome timeframe
7 days
Results posted on
2024-04-08
Participant Flow
Participant milestones
| Measure |
1A: Healthy, 2.5 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
3
|
26
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
3
|
26
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=26 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
n=13 Participants
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=3 Participants
|
28 years
n=3 Participants
|
28 years
n=3 Participants
|
26.5 years
n=6 Participants
|
43 years
n=3 Participants
|
40 years
n=26 Participants
|
32 years
n=13 Participants
|
32 years
n=57 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=3 Participants
|
11 Participants
n=26 Participants
|
5 Participants
n=13 Participants
|
27 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=3 Participants
|
15 Participants
n=26 Participants
|
8 Participants
n=13 Participants
|
30 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Germany
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=3 Participants
|
26 Participants
n=26 Participants
|
13 Participants
n=13 Participants
|
57 Participants
n=57 Participants
|
PRIMARY outcome
Timeframe: 7 daysOutcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=26 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
n=13 Participants
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
Proportion of Patients With Any AE Within 7 d of Study Drug Infusion
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post doseDZIF-10c serum elimination half-life
Outcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=26 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
DZIF-10c Elimination Half Life
|
28.4 days
Geometric Coefficient of Variation 17.5
|
24.2 days
Geometric Coefficient of Variation 12.8
|
20.1 days
Geometric Coefficient of Variation 9.53
|
20.9 days
Geometric Coefficient of Variation 25.4
|
16.8 days
Geometric Coefficient of Variation 45
|
21.8 days
Geometric Coefficient of Variation 12.2
|
—
|
SECONDARY outcome
Timeframe: 0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post doseOutcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=26 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
DZIF-10c Peak Serum Concentration
|
54.3 µg/ml
Geometric Coefficient of Variation 12.6
|
207 µg/ml
Geometric Coefficient of Variation 8.92
|
738 µg/ml
Geometric Coefficient of Variation 7.94
|
1480 µg/ml
Geometric Coefficient of Variation 10.2
|
983 µg/ml
Geometric Coefficient of Variation 8.9
|
970 µg/ml
Geometric Coefficient of Variation 21.5
|
—
|
SECONDARY outcome
Timeframe: 0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post doseArea under the curve based on serum antibody levels
Outcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=26 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
DZIF-10c Area Under the Curve
|
15400 µg h/ml
Geometric Coefficient of Variation 5.79
|
61700 µg h/ml
Geometric Coefficient of Variation 14.3
|
212000 µg h/ml
Geometric Coefficient of Variation 18.9
|
358000 µg h/ml
Geometric Coefficient of Variation 14
|
236000 µg h/ml
Geometric Coefficient of Variation 24.4
|
235000 µg h/ml
Geometric Coefficient of Variation 15.5
|
—
|
SECONDARY outcome
Timeframe: 0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post doseOutcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=23 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
DZIF-10c Clearance
|
311 ml/day
Geometric Coefficient of Variation 10.6
|
242 ml/day
Geometric Coefficient of Variation 26.8
|
282 ml/day
Geometric Coefficient of Variation 40.8
|
341 ml/day
Geometric Coefficient of Variation 14.1
|
280 ml/day
Geometric Coefficient of Variation 24.2
|
339 ml/day
Geometric Coefficient of Variation 20.6
|
—
|
SECONDARY outcome
Timeframe: 0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post doseOutcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=26 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
DZIF-10c Volume of Distribution Vz
|
12800 ml
Geometric Coefficient of Variation 11.7
|
8460 ml
Geometric Coefficient of Variation 18
|
8160 ml
Geometric Coefficient of Variation 45.7
|
10300 ml
Geometric Coefficient of Variation 21.8
|
6790 ml
Geometric Coefficient of Variation 29.6
|
10700 ml
Geometric Coefficient of Variation 19.7
|
—
|
SECONDARY outcome
Timeframe: 0, 14, 28, 56, 90 days post doseIndividuals developing anti-drug antibodies
Outcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
n=6 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
n=3 Participants
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
n=26 Participants
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
Anti-Drug Antibody Development
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 0, 14, 28, 56, 90 days post doseMagnitude of the development of anti-drug antibodies targeting DZIF-10c in individuals developing such antibodies (peak serum titer)
Outcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=1 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
Anti-Drug Antibody Peak Titer
|
960 reciprocal serum titer
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 3, 7, 14, 28 days post doseTime-weighted change of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on a parametric analysis of covariance model with corresponding baseline viral load, antibody status at baseline, and treatment; determined as the adjusted mean area over the curve (AOC) for samples collected at baseline and 1, 3, 7, 14, 28 days post dose
Outcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=26 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=13 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
Time-weighted SARS-CoV-2 Viral Load Change From Baseline
Over 7 days
|
-2.035 log10 cp/ml
Standard Error 0.146
|
-1.449 log10 cp/ml
Standard Error 0.217
|
—
|
—
|
—
|
—
|
—
|
|
Time-weighted SARS-CoV-2 Viral Load Change From Baseline
Over 14 days
|
-3.273 log10 cp/ml
Standard Error 0.126
|
-2.668 log10 cp/ml
Standard Error 0.188
|
—
|
—
|
—
|
—
|
—
|
|
Time-weighted SARS-CoV-2 Viral Load Change From Baseline
Over 28 days
|
-3.938 log10 cp/ml
Standard Error 0.096
|
-3.576 log10 cp/ml
Standard Error 0.143
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 3, 7, 14, 28 days post doseChange of SARS-CoV-2 viral load from baseline in nasopharyngeal swab samples as determined by the SARS-CoV-2 E gene; based on Mixed Model for Repeated Measures (MMRM) with fixed effects for antibody status at BL, LOG10 (viral load) at BL and interaction with visit, treatment-by-visit interaction, and random effect for patient; samples collected at baseline and 1, 3, 7, 14, 28 days post dose
Outcome measures
| Measure |
1A: Healthy, 2.5 mg/kg
n=26 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1B: Healthy, 10 mg/kg
n=13 Participants
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1C: Healthy, 40 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
1D: Healthy, 80 mg/kg
Open label, SARS-CoV-2 negative, DZIF-10c i.v. infusion
|
2C: Infected, 40 mg/kg
Open label, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, 40 mg/kg
Double-blind and randomized, SARS-CoV-2-infected, DZIF-10c i.v. infusion
|
2D: Infected, Placebo
Double-blind and randomized, SARS-CoV-2-infected, placebo i.v. infusion
|
|---|---|---|---|---|---|---|---|
|
MMRM SARS-CoV-2 Viral Load Change From Baseline
Over 7 days
|
-4.3 Adjusted log10 cp/ml
Standard Error 0.2
|
-3.3 Adjusted log10 cp/ml
Standard Error 0.3
|
—
|
—
|
—
|
—
|
—
|
|
MMRM SARS-CoV-2 Viral Load Change From Baseline
Over 14 days
|
-4.5 Adjusted log10 cp/ml
Standard Error 0.2
|
-4.3 Adjusted log10 cp/ml
Standard Error 0.3
|
—
|
—
|
—
|
—
|
—
|
|
MMRM SARS-CoV-2 Viral Load Change From Baseline
Over 28 days
|
-4.7 Adjusted log10 cp/ml
Standard Error 0.1
|
-4.6 Adjusted log10 cp/ml
Standard Error 0.1
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
1A: Healthy, 2.5 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1B: Healthy, 10 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1C: Healthy, 40 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1D: Healthy, 80 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2C: Infected, 40 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2D: Infected, 40 mg/kg
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
2D: Infected, Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1A: Healthy, 2.5 mg/kg
n=3 participants at risk
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 2.5 mg/kg
DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
|
1B: Healthy, 10 mg/kg
n=3 participants at risk
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 10 mg/kg
DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
|
1C: Healthy, 40 mg/kg
n=3 participants at risk
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg
DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
|
1D: Healthy, 80 mg/kg
n=6 participants at risk
SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose higher than 40 mg/kg
DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
|
2C: Infected, 40 mg/kg
n=3 participants at risk
SARS-CoV-2-infected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg
DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
|
2D: Infected, 40 mg/kg
n=26 participants at risk
SARS-CoV-2-infected volunteers randomized to receive an intravenous infusion of DZIF-10c at a dose of 40 mg/kg (blinded)
DZIF-10c: SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
|
2D: Infected, Placebo
n=13 participants at risk
SARS-CoV-2-infected volunteers randomized to receive an intravenous infusion of placebo (blinded)
Placebo: Sterile normal saline
|
|---|---|---|---|---|---|---|---|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
11.5%
3/26 • Number of events 3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
30.8%
8/26 • Number of events 10 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
30.8%
4/13 • Number of events 5 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
15.4%
4/26 • Number of events 4 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
23.1%
3/13 • Number of events 3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
30.8%
8/26 • Number of events 9 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
38.5%
5/13 • Number of events 5 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
15.4%
2/13 • Number of events 2 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
15.4%
2/13 • Number of events 2 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Nervous system disorders
Parosmia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Nervous system disorders
Ageusia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
General disorders
Pain
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
15.4%
4/26 • Number of events 4 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
15.4%
2/13 • Number of events 2 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
General disorders
Fatigue
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
General disorders
Malaise
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 2 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Gastrointestinal disorders
Proctalgia
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 2 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Infections and infestations
Rhinitis
|
33.3%
1/3 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/26 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
7.7%
1/13 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/6 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/3 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
3.8%
1/26 • Number of events 1 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
0.00%
0/13 • Treatment-emergent adverse events: All adverse events after drug intake until final study visit (Day 90 visit)
Participants were queried for Adverse Events at all study visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications by PIs are to be submitted to the sponsor for review at least 30 days prior to planned disclosure. Modifications suggested by the sponsor should be considered unless they affect the scientific character or neutrality of the publication. A maximum embargo period of 90 days is applicable only if disclosure would affect (potential) intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER