Trial Outcomes & Findings for Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 (NCT NCT04632706)
NCT ID: NCT04632706
Last Updated: 2021-12-27
Results Overview
Maximum plasma concentration (Cmax)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
D1, D2 and D28
Results posted on
2021-12-27
Participant Flow
Participant milestones
| Measure |
50mcg/kg (Oral)
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
|
75mcg/kg (Oral)
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
|
100mcg/kg (Oral)
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
|
Matching Placebo (Oral)
Placebo tablets matching the Active Investigative Medicinal Product (IMP)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
50mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
|
75mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
|
100mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
|
Matching Placebo (Oral)
n=6 Participants
Placebo tablets matching the Active IMP
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
35.2 years
n=6 Participants
|
29.3 years
n=6 Participants
|
30.3 years
n=6 Participants
|
28.2 years
n=6 Participants
|
30.8 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
24 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=6 Participants
|
24 participants
n=24 Participants
|
|
Body Mass Index
|
24.95 kg/m^2
n=6 Participants
|
25.79 kg/m^2
n=6 Participants
|
25.84 kg/m^2
n=6 Participants
|
25.57 kg/m^2
n=6 Participants
|
25.54 kg/m^2
n=24 Participants
|
PRIMARY outcome
Timeframe: D1, D2 and D28Population: All 18 participants on active IMP were eligible and analyzed for this endpoint. Number Analyzed per Row represents those with data available at each time point.
Maximum plasma concentration (Cmax)
Outcome measures
| Measure |
50mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
|
75mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
|
100mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
|
Matching Placebo (Oral)
Placebo tablets matching the Active IMP
|
|---|---|---|---|---|
|
Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax])
Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups
|
57.2 ng/mL
Geometric Coefficient of Variation 28.9
|
41.7 ng/mL
Geometric Coefficient of Variation 73.5
|
46.5 ng/mL
Geometric Coefficient of Variation 53.6
|
—
|
|
Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax])
Day 2 (first day on respective dose of active treatment)
|
22.3 ng/mL
Geometric Coefficient of Variation 32.5
|
24.4 ng/mL
Geometric Coefficient of Variation 42.5
|
33.2 ng/mL
Geometric Coefficient of Variation 62.6
|
—
|
|
Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax])
Day 28 (last day of active treatment)
|
23.3 ng/mL
Geometric Coefficient of Variation 52.8
|
31.9 ng/mL
Geometric Coefficient of Variation 27.6
|
44.4 ng/mL
Geometric Coefficient of Variation 68.8
|
—
|
PRIMARY outcome
Timeframe: D1, D2 and D28Population: All 18 participants on active IMP were eligible and analyzed for this endpoint. Number Analyzed per Row represents those with data available at each time point.
Time to reach Cmax (Tmax)
Outcome measures
| Measure |
50mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
|
75mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
|
100mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
|
Matching Placebo (Oral)
Placebo tablets matching the Active IMP
|
|---|---|---|---|---|
|
Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax])
Day 28 (last day of active treatment)
|
2.83 hr
Geometric Coefficient of Variation 39.2
|
3.03 hr
Geometric Coefficient of Variation 50.7
|
3.03 hr
Geometric Coefficient of Variation 39.4
|
—
|
|
Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax])
Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups
|
2.53 hr
Geometric Coefficient of Variation 36.8
|
3.03 hr
Geometric Coefficient of Variation 50.6
|
4.8 hr
Geometric Coefficient of Variation 47.2
|
—
|
|
Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax])
Day 2 (first day on respective dose of active treatment)
|
3.82 hr
Geometric Coefficient of Variation 36.7
|
2.85 hr
Geometric Coefficient of Variation 38.8
|
3.23 hr
Geometric Coefficient of Variation 34.5
|
—
|
PRIMARY outcome
Timeframe: D1, D2 and D28Population: All 18 participants on active IMP were eligible and analyzed for this endpoint. Number Analyzed per Row represents those with data available at each time point.
area under the plasma concentration-time curve from zero to 24 hours (AUC0-24hr) concentration-time curve from zero to 24 hours (AUC0-24hr)
Outcome measures
| Measure |
50mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
|
75mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
|
100mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
|
Matching Placebo (Oral)
Placebo tablets matching the Active IMP
|
|---|---|---|---|---|
|
Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr])
Day 28 (last day of active treatment)
|
1.06 ng*h/mL
Geometric Coefficient of Variation 36.6
|
1.5 ng*h/mL
Geometric Coefficient of Variation 47.5
|
1.75 ng*h/mL
Geometric Coefficient of Variation 20.6
|
—
|
|
Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr])
Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups
|
568 ng*h/mL
Geometric Coefficient of Variation 33.6
|
449 ng*h/mL
Geometric Coefficient of Variation 62.0
|
523 ng*h/mL
Geometric Coefficient of Variation 60.5
|
—
|
|
Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr])
Day 2 (first day on respective dose of active treatment)
|
906 ng*h/mL
Geometric Coefficient of Variation 31.4
|
779 ng*h/mL
Geometric Coefficient of Variation 53.1
|
941 ng*h/mL
Geometric Coefficient of Variation 59.0
|
—
|
PRIMARY outcome
Timeframe: D28Population: 17 participants on active IMP were analysed for this endpoint. On day 21 one subject in the 100 μg/kg/day ivermectin treatment group was discontinued.
apparent terminal half-life (t1/2)
Outcome measures
| Measure |
50mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
|
75mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
|
100mcg/kg (Oral)
n=5 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
|
Matching Placebo (Oral)
Placebo tablets matching the Active IMP
|
|---|---|---|---|---|
|
Pharmacokinetic Concentrations - (Apparent Terminal Half-Life [T1/2])
|
102 hr
Geometric Coefficient of Variation 60.1
|
99.2 hr
Geometric Coefficient of Variation 47.3
|
127 hr
Geometric Coefficient of Variation 47.2
|
—
|
SECONDARY outcome
Timeframe: From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days.Population: All 24 included participants were eligible and analysed for this endpoint
Clinical safety data from adverse event (AE) reporting
Outcome measures
| Measure |
50mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28
|
75mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28
|
100mcg/kg (Oral)
n=6 Participants
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
|
Matching Placebo (Oral)
n=6 Participants
Placebo tablets matching the Active IMP
|
|---|---|---|---|---|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
24 TEAE
|
5 TEAE
|
2 TEAE
|
21 TEAE
|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
Any serious TEAE
|
0 TEAE
|
0 TEAE
|
0 TEAE
|
0 TEAE
|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to discontinuation - due to Study Medication-related TEAE
|
0 TEAE
|
0 TEAE
|
0 TEAE
|
0 TEAE
|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to discontinuation - other reason
|
0 TEAE
|
0 TEAE
|
1 TEAE
|
0 TEAE
|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
TEAE - mild severity
|
24 TEAE
|
5 TEAE
|
2 TEAE
|
20 TEAE
|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
TEAE - moderate severity
|
0 TEAE
|
0 TEAE
|
0 TEAE
|
1 TEAE
|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
Causality (All TEAEs) - Not related
|
21 TEAE
|
3 TEAE
|
2 TEAE
|
20 TEAE
|
|
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
Causality (All TEAEs) - Related (possibly and probably)
|
3 TEAE
|
2 TEAE
|
0 TEAE
|
1 TEAE
|
Adverse Events
50mcg/kg (Oral)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
75mcg/kg (Oral)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100mcg/kg (Oral)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Matching Placebo (Oral)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Ivermectin Overall
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Total (Ivermectin Overall and Placebo)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
50mcg/kg (Oral)
n=6 participants at risk
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28.
|
75mcg/kg (Oral)
n=6 participants at risk
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28.
|
100mcg/kg (Oral)
n=6 participants at risk
Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28.
|
Matching Placebo (Oral)
n=6 participants at risk
Placebo tablets matching the Active IMP
|
Ivermectin Overall
n=18 participants at risk
Ivermectin loading dose of 200 mcg/kg followed by daily doses of either 50, 75, or 100mcg/kg from D2 to D28.
|
Total (Ivermectin Overall and Placebo)
n=24 participants at risk
All study participants
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
11.1%
2/18 • Number of events 3 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
8.3%
2/24 • Number of events 3 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 4 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
3/18 • Number of events 4 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
4/24 • Number of events 5 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
11.1%
2/18 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
12.5%
3/24 • Number of events 3 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 5 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
22.2%
4/18 • Number of events 6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
20.8%
5/24 • Number of events 7 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
33.3%
2/6 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
12.5%
3/24 • Number of events 3 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Nervous system disorders
Somnolence
|
33.3%
2/6 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
11.1%
2/18 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
8.3%
2/24 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
33.3%
2/6 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
8.3%
2/24 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
11.1%
2/18 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
8.3%
2/24 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/18 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
5.6%
1/18 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
4.2%
1/24 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
0.00%
0/6 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
16.7%
1/6 • Number of events 1 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
11.1%
2/18 • Number of events 2 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
12.5%
3/24 • Number of events 3 • From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI does not have the right to publish or otherwise present any results or data related to the study without an expressed written agreement from the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER