Trial Outcomes & Findings for A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1) (NCT NCT06186492)
NCT ID: NCT06186492
Last Updated: 2026-03-23
Results Overview
The number of participants who reported an adverse event (AE) will be summarised.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
47 participants
Primary outcome timeframe
Adverse events are collected from the date of consent until up to 85 days after the dose in Period 1 and up to 113 days after the first dose in Period 2.
Results posted on
2026-03-23
Participant Flow
Study recruitment was undertaken at one site in the United Kingdom. The recruitment process began in November 2023 and concluded in October 2024. A sufficient number of volunteers were screened in order to successfully recruit 46 completing participants (with one participant withdrawal).
Participants were screened to the inclusion/exclusion of the protocol. The following assessments were performed: Consent, Demographics, Medical History, Prior/Concomitant Medications, AAT Testing, Pregnancy/FSH, Vital signs, Physical examination, Laboratory Safety Testing, ECG, Urine Drugs of Abuse Testing . The study included 2 distinct periods: Period 1 (SAD) and Period 2 (multiple dose). A total of 39 participants were randomised to Period 1 and 8 participants were randomised to Period 2.
Participant milestones
| Measure |
Period 1: Pooled Placebo
Participants were randomised to receive a single dose of placebo on Day 1
|
Period 1 Cohort 1 - WVE-006 30 mg
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
5
|
6
|
6
|
6
|
6
|
2
|
|
Overall Study
COMPLETED
|
10
|
6
|
5
|
6
|
6
|
5
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Period 1: Pooled Placebo
Participants were randomised to receive a single dose of placebo on Day 1
|
Period 1 Cohort 1 - WVE-006 30 mg
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase 1 Research Study to Evaluate Safety, Tolerability, and Pharmacokinetics of WVE-006 in Healthy Participants With Wild-type AAT Expression (RestorAATion-1)
Baseline characteristics by cohort
| Measure |
Period 1: Pooled Placebo
n=10 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
n=5 Participants
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
n=6 Participants
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
n=2 Participants
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=18 Participants
|
6 Participants
n=158 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=1 Participants
|
6 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
47 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Age, Continuous
|
35.8 Years
STANDARD_DEVIATION 9.0 • n=10 Participants
|
34.0 Years
STANDARD_DEVIATION 8.7 • n=8 Participants
|
44.4 Years
STANDARD_DEVIATION 11.9 • n=18 Participants
|
34.0 Years
STANDARD_DEVIATION 10.2 • n=158 Participants
|
36.8 Years
STANDARD_DEVIATION 9.3 • n=3 Participants
|
34.8 Years
STANDARD_DEVIATION 8.9 • n=1 Participants
|
39.0 Years
STANDARD_DEVIATION 12.1 • n=2 Participants
|
39.5 Years
STANDARD_DEVIATION 7.8 • n=2 Participants
|
36.4 Years
STANDARD_DEVIATION 9.5 • n=2 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
4 Participants
n=158 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
18 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=18 Participants
|
2 Participants
n=158 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=1 Participants
|
5 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
29 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=18 Participants
|
6 Participants
n=158 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=1 Participants
|
6 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
46 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=18 Participants
|
6 Participants
n=158 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=1 Participants
|
4 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
44 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=158 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=10 Participants
|
6 participants
n=8 Participants
|
5 participants
n=18 Participants
|
6 participants
n=158 Participants
|
6 participants
n=3 Participants
|
6 participants
n=1 Participants
|
6 participants
n=2 Participants
|
2 participants
n=2 Participants
|
47 participants
n=2 Participants
|
|
Weight
|
77.57 Kilograms
STANDARD_DEVIATION 11.61 • n=10 Participants
|
82.38 Kilograms
STANDARD_DEVIATION 14.75 • n=8 Participants
|
89.60 Kilograms
STANDARD_DEVIATION 8.78 • n=18 Participants
|
65.40 Kilograms
STANDARD_DEVIATION 10.88 • n=158 Participants
|
73.95 Kilograms
STANDARD_DEVIATION 8.45 • n=3 Participants
|
82.45 Kilograms
STANDARD_DEVIATION 9.59 • n=1 Participants
|
74.10 Kilograms
STANDARD_DEVIATION 16.61 • n=2 Participants
|
91.20 Kilograms
STANDARD_DEVIATION 28.43 • n=2 Participants
|
78.17 Kilograms
STANDARD_DEVIATION 12.54 • n=2 Participants
|
|
Height
|
1.740 Metres
STANDARD_DEVIATION 0.103 • n=10 Participants
|
1.678 Metres
STANDARD_DEVIATION 0.113 • n=8 Participants
|
1.792 Metres
STANDARD_DEVIATION 0.064 • n=18 Participants
|
1.677 Metres
STANDARD_DEVIATION 0.078 • n=158 Participants
|
1.722 Metres
STANDARD_DEVIATION 0.083 • n=3 Participants
|
1.742 Metres
STANDARD_DEVIATION 0.037 • n=1 Participants
|
1.748 Metres
STANDARD_DEVIATION 0.100 • n=2 Participants
|
1.770 Metres
STANDARD_DEVIATION 0.184 • n=2 Participants
|
1.725 Metres
STANDARD_DEVIATION 0.089 • n=2 Participants
|
|
Body Mass Index
|
25.496 Kilograms per metre 2
STANDARD_DEVIATION 1.853 • n=10 Participants
|
29.048 Kilograms per metre 2
STANDARD_DEVIATION 2.369 • n=8 Participants
|
28.000 Kilograms per metre 2
STANDARD_DEVIATION 3.513 • n=18 Participants
|
23.123 Kilograms per metre 2
STANDARD_DEVIATION 2.294 • n=158 Participants
|
24.892 Kilograms per metre 2
STANDARD_DEVIATION 1.371 • n=3 Participants
|
27.157 Kilograms per metre 2
STANDARD_DEVIATION 2.687 • n=1 Participants
|
24.000 Kilograms per metre 2
STANDARD_DEVIATION 3.567 • n=2 Participants
|
28.635 Kilograms per metre 2
STANDARD_DEVIATION 3.104 • n=2 Participants
|
26.161 Kilograms per metre 2
STANDARD_DEVIATION 2.913 • n=2 Participants
|
PRIMARY outcome
Timeframe: Adverse events are collected from the date of consent until up to 85 days after the dose in Period 1 and up to 113 days after the first dose in Period 2.Population: This analysis population included 47 enrolled participants who received at least one dose of WVE-006 or matching placebo.
The number of participants who reported an adverse event (AE) will be summarised.
Outcome measures
| Measure |
Period 1: Pooled Placebo
n=10 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
n=5 Participants
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
n=6 Participants
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
n=2 Participants
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
The Proportion of Participants With Adverse Events
|
8 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85.Population: This analysis population includes the 29 participants who received at least one dose of WVE-006 and were selected as part of the PK analysis set for Period 1.
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 1 of the study.
Outcome measures
| Measure |
Period 1: Pooled Placebo
n=6 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
n=5 Participants
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose (Period 1) - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast)
|
626 h*ng/mL
Standard Deviation 115
|
1978 h*ng/mL
Standard Deviation 357
|
7507 h*ng/mL
Standard Deviation 4427
|
29466 h*ng/mL
Standard Deviation 10688
|
53342 h*ng/mL
Standard Deviation 13166
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples collected at the following timepoints: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr & 12 hr post-Day 1 dose, Day 2: 24 hr & 36 hr post-Day 1 dose, Day 3: 48 hr post-Day 1 dose, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 & 85.Population: This analysis population includes the 29 participants who received at least one dose of WVE-006 and were selected as part of the PK analysis set for Period 1.
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 1 of the study.
Outcome measures
| Measure |
Period 1: Pooled Placebo
n=6 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
n=5 Participants
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
n=6 Participants
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Single Ascending Dose - Maximum Concentration of WVE-006 in Plasma (Cmax)
|
40.4 ng/mL
Standard Deviation 11.6
|
112 ng/mL
Standard Deviation 42.2
|
562 ng/mL
Standard Deviation 440
|
2038 ng/mL
Standard Deviation 864
|
3718 ng/mL
Standard Deviation 963
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.Population: This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2.
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study.
Outcome measures
| Measure |
Period 1: Pooled Placebo
n=6 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 1
|
75678 h*ng/mL
Standard Deviation 44053
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples collected at the following timepoints for Day 1 measurement: Day 1 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.Population: This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2.
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study.
Outcome measures
| Measure |
Period 1: Pooled Placebo
n=6 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 1
|
5929 ng/mL
Standard Deviation 4933
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.Population: This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2.
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Area under the plasma concentration time curve for WVE-006 from time of dosing to the last measurable concentration (AUClast) of WVE-006 in plasma for participants in Period 2 of the study.
Outcome measures
| Measure |
Period 1: Pooled Placebo
n=6 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Doses - Area Under the Plasma Concentration Time Curve for WVE-006 From Time of Dosing to the Last Measurable Concentration (AUClast) - Day 29
|
75824 h*ng/mL
Standard Deviation 44437
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Samples collected at the following timepoints for Day 29 measurement: Day 29 pre-dose, 30 mins, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr & 24 hr post-dose.Population: This analysis population includes the 6 participants who received all doses of WVE-006 and were selected as part of the PK analysis set for Period 2.
Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for WVE-006. This endpoint will report the summary of derived pharmacokinetic parameters for the Maximum concentration of WVE-006 in plasma (Cmax) of WVE-006 in plasma for participants in Period 2 of the study.
Outcome measures
| Measure |
Period 1: Pooled Placebo
n=6 Participants
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Multiple Ascending Doses - Maximum Concentration of WVE-006 in Plasma (Cmax) - Day 29
|
5995 ng/mL
Standard Deviation 5419
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Period 1: Pooled Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Period 1 Cohort 1 - WVE-006 30 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Period 1 Cohort 2 - WVE-006 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 1 Cohort 3 - WVE-006 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 1 Cohort 4 - WVE-006 400 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 1 Cohort 5 - WVE-006 600 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Period 2 Cohort 1 - WVE-006 600 mg Q2W
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Period 2 Cohort 1 - Placebo Q2W
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Period 1: Pooled Placebo
n=10 participants at risk
Participants were randomised to receive a single dose of placebo on Day 1.
|
Period 1 Cohort 1 - WVE-006 30 mg
n=6 participants at risk
Participants were randomised to receive a single dose of WVE-006 30 mg on Day 1.
|
Period 1 Cohort 2 - WVE-006 100 mg
n=5 participants at risk
Participants were randomised to receive a single dose of WVE-006 100 mg on Day 1.
|
Period 1 Cohort 3 - WVE-006 200 mg
n=6 participants at risk
Participants were randomised to receive a single dose of WVE-006 200 mg on Day 1.
|
Period 1 Cohort 4 - WVE-006 400 mg
n=6 participants at risk
Participants were randomised to receive a single dose of WVE-006 400 mg on Day 1.
|
Period 1 Cohort 5 - WVE-006 600 mg
n=6 participants at risk
Participants were randomised to receive a single dose of WVE-006 600 mg on Day 1.
|
Period 2 Cohort 1 - WVE-006 600 mg Q2W
n=6 participants at risk
Participants were randomised to receive WVE-006 600 mg Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
Period 2 Cohort 1 - Placebo Q2W
n=2 participants at risk
Participants were randomised to receive placebo Q2W for 3 doses (on Day 1, Day 15 \& Day 29).
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
40.0%
2/5 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Investigations
Blood Creatinine Phosphokinase Increased
|
10.0%
1/10 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
40.0%
2/5 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Infections and infestations
Influenza like Illness
|
10.0%
1/10 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
33.3%
2/6 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
33.3%
2/6 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
2/10 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
33.3%
2/6 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
20.0%
1/5 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Investigations
Transaminases Increased
|
10.0%
1/10 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
40.0%
2/5 • Number of events 2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
20.0%
1/5 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Investigations
Catheter Site Pain
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Gastrointestinal disorders
Dysmenorrhoea
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
General disorders
Fatigue
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
General disorders
Injection Site Reaction
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Gastrointestinal disorders
Oropharyngeal Pain
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Renal and urinary disorders
Pollakuria
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Injury, poisoning and procedural complications
Toothache
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
20.0%
1/5 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Ear and labyrinth disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
16.7%
1/6 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/2 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
0.00%
0/10 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/5 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
0.00%
0/6 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
50.0%
1/2 • Number of events 1 • Adverse events were reported through ad hoc reporting from the participants from the point of signature of informed consent through to study completion (up to 85 days in Period 1 and up to 113 days in Period 2).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place