Trial Outcomes & Findings for Study of DCR-AUD in Healthy Volunteers (NCT NCT05021640)
NCT ID: NCT05021640
Last Updated: 2024-12-27
Results Overview
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as an AE that begins or that worsens in severity after the study drug has been administered. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly /birth defect, is the other important medical event.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
From Day 1 up to 24 Weeks
Results posted on
2024-12-27
Participant Flow
In this trial 36 healthy participants were randomized to four ascending-dose cohorts (80 milligram \[mg\], 240 mg, 480 mg, 960 mg) and placebo.
Participant milestones
| Measure |
Cohort 1: DCR-AUD 80 mg
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
Safety Population
|
6
|
6
|
6
|
6
|
12
|
|
Overall Study
Pharmacodynamic Population
|
4
|
4
|
4
|
4
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1: DCR-AUD 80 mg
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of DCR-AUD in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 10.29 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 12.26 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 14.44 • n=5 Participants
|
32.8 years
STANDARD_DEVIATION 4.88 • n=4 Participants
|
41.3 years
STANDARD_DEVIATION 12.19 • n=21 Participants
|
39.6 years
STANDARD_DEVIATION 12.48 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 24 WeeksPopulation: Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention.
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as an AE that begins or that worsens in severity after the study drug has been administered. An SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly /birth defect, is the other important medical event.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 24 WeeksPopulation: Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as an AE that begins or that worsens in severity after the study drug has been administered. As per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated; Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living; Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living; Grade 4: life-threatening consequences; urgent treatment indicated; Grade 5: fatal.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=4 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=5 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=4 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=2 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=9 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Severity Grades of TEAEs
Grade 1
|
4 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants With Severity Grades of TEAEs
Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Severity Grades of TEAEs
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Severity Grades of TEAEs
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Severity Grades of TEAEs
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to 24 WeeksPopulation: Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention.
DLT is defined as an AE of greater than or equal to (\>=) Grade 3 intensity (CTCAE Version 5.0) in one participant, unless it is clearly the result of a non-study-related event OR any 2 AEs of \>= Grade 2 intensity in the same body system in one participant.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day -1) up to 24 weeksPopulation: Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention.
Number of participants with change from baseline in clinically significant abnormal vital signs (temperature, pulse rate, respiratory rate, and blood pressure) is presented.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Clinically Significant Abnormal Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day -1) up to 24 weeksPopulation: Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention.
Number of participants with change from baseline in clinically significant abnormal ECG findings (Heart rate, PR interval, QRS interval, QT interval and QT interval using Fridericia's correction \[QTcF\]) is presented.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Clinically Significant Abnormal Electrocardiogram (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day -1) up to 24 weeksPopulation: Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention.
Number of participants with change from baseline in clinically significant abnormal laboratory values (hematology, clinical chemistry, coagulation and routine urinalysis parameters) is presented.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Clinically Significant Abnormal Laboratory Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline (Day -1) up to 24 weeksPopulation: Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention.
Number of participants with change from baseline in clinically significant physical examination findings (assessments of the cardiovascular, respiratory, gastrointestinal, neurological, and skin systems and inspection of the injection site) is presented.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Clinically Significant Physical Examination Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, at 15 and 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72 hours post dose; Day 15: Once Post dosePopulation: Pharmacokinetic (PK) analysis population included all participants randomly assigned to study intervention and who received a full dose of DCR-AUD and had sufficient data for at least 1 postdose PK assessment.
AUC0-last is defined as the area under the plasma concentration curve from time zero to the last quantifiable concentration of DCR-AUD.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
AUC0-last: Area Under the Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration of DCR-AUD
|
5710 hour*nanogram per millilitre (h*ng/mL)
Geometric Coefficient of Variation 25.2
|
19300 hour*nanogram per millilitre (h*ng/mL)
Geometric Coefficient of Variation 18.8
|
49000 hour*nanogram per millilitre (h*ng/mL)
Geometric Coefficient of Variation 26.9
|
106000 hour*nanogram per millilitre (h*ng/mL)
Geometric Coefficient of Variation 29.3
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, at 15 and 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72 hours post dose; Day 15: Once Post dosePopulation: PK analysis population included all participants randomly assigned to study intervention and who received a full dose of DCR-AUD and had sufficient data for at least 1 postdose PK assessment.
Cmax is defined as maximum observed plasma concentration of DCR-AUD during a dosing interval.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration of DCR-AUD
|
371 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 20.4
|
956 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 26.3
|
2580 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 46.1
|
5350 nanogram per millilitre (ng/mL)
Geometric Coefficient of Variation 51.3
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, at 15 and 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72 hours post dose; Day 15: Once Post dosePopulation: PK analysis population included all participants randomly assigned to study intervention and who received a full dose of DCR-AUD and had sufficient data for at least 1 postdose PK assessment.
Tmax is defined as time to reach the maximum plasma concentration (Cmax) of DCR-AUD.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration of DCR-AUD (Cmax)
|
4.00 hours
Interval 0.5 to 8.22
|
7.17 hours
Interval 1.15 to 8.02
|
4.05 hours
Interval 1.13 to 8.03
|
6.00 hours
Interval 0.65 to 8.12
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, at 15 and 30 minutes, 1, 2, 4, 6, 8, 24, 48, 72 hours post dose; Day 15: Once Post dosePopulation: PK analysis population included all participants randomly assigned to study intervention and who received a full dose of DCR-AUD and had sufficient data for at least 1 postdose PK assessment. Here, Overall Number of Participants Analyzed" signifies participants with available data for this outcome measure.
t1/2 is defined as apparent terminal elimination half-life of DCR-AUD.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=3 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=4 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=2 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=1 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
t1/2: Apparent Terminal Elimination Half-life of DCR-AUD
|
7.67 hours
Interval 6.26 to 8.74
|
7.62 hours
Interval 6.35 to 8.84
|
NA hours
Interval 4.67 to 5.82
Median is not calculable due to two participants with data
|
NA hours
Interval 35.4 to 35.4
Median is not calculable due to one participant with data
|
—
|
SECONDARY outcome
Timeframe: At time interval between 0- 4 hours, 0- 8 hours, 0-12 hours, 0-24 hours, 0-48 hours, 0-72 hoursPopulation: PK analysis population included all participants randomly assigned to study intervention and who received a full dose of DCR-AUD and had sufficient data for at least 1 postdose PK assessment.
Urinary cumulative excretion as % of DCR-AUD at each interval collection (0- 4 hours, 0- 8 hours, 0-12 hours, 0-24 hours, 0-48 hours, 0-72 hours) is reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Fe%0-72: Urinary Cumulative Excretion as % of Unchanged DCR-AUD up to 72 Hours
Fe%0-4
|
1.47 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 38.1
|
2.51 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 32.9
|
4.23 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 24.7
|
3.85 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 28.9
|
—
|
|
Fe%0-72: Urinary Cumulative Excretion as % of Unchanged DCR-AUD up to 72 Hours
Fe%0-8
|
7.22 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 38.2
|
8.68 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 26.8
|
10.8 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 42.4
|
10.4 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 39.2
|
—
|
|
Fe%0-72: Urinary Cumulative Excretion as % of Unchanged DCR-AUD up to 72 Hours
Fe%0-12
|
12.8 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 26.8
|
12.8 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 27.2
|
17.6 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 28.5
|
19.2 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 33.5
|
—
|
|
Fe%0-72: Urinary Cumulative Excretion as % of Unchanged DCR-AUD up to 72 Hours
Fe%0-24
|
24.6 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 17.0
|
23.6 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 43.9
|
35.2 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 21.9
|
35.6 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 32.6
|
—
|
|
Fe%0-72: Urinary Cumulative Excretion as % of Unchanged DCR-AUD up to 72 Hours
Fe%0-48
|
28.8 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 18.1
|
28.5 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 40.8
|
41.6 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 13.7
|
43.7 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 20.5
|
—
|
|
Fe%0-72: Urinary Cumulative Excretion as % of Unchanged DCR-AUD up to 72 Hours
Fe%0-72
|
28.9 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 18.1
|
28.9 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 40.6
|
42.2 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 12.6
|
45.1 percentage of unchanged DCR-AUD
Geometric Coefficient of Variation 19.4
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72-hours post-dosePopulation: PK analysis population included all participants randomly assigned to study intervention and who received a full dose of DCR-AUD and had sufficient data for at least 1 postdose PK assessment.
Renal clearance of the DCR-AUD from plasma is reported in this outcome measure.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=6 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
CLR: Renal Clearance of the DCR-AUD From Plasma
|
3760 Liter per hour (L/h)
Geometric Coefficient of Variation 13.5
|
3590 Liter per hour (L/h)
Geometric Coefficient of Variation 27.1
|
4170 Liter per hour (L/h)
Geometric Coefficient of Variation 27.8
|
4180 Liter per hour (L/h)
Geometric Coefficient of Variation 25.0
|
—
|
SECONDARY outcome
Timeframe: Day -1, Day 4, Day 15, Day 29, Day 57, Day 85, Day 113 and Day 169Population: Pharmacodynamic population (PP) included all participants randomly assigned to study intervention and who received a full dose of study intervention and had sufficient data for at least 1 postdose pharmacodynamic (PD) assessment. Here, number analysed signifies participants with available data for each specified category.
The degree of aldehyde dehydrogenase 2 (ALDH2) reduction was measured by quantitative assessment of 6 symptom (flushing, headache, palpitations, light-headedness, nausea, and vomiting) responses during EIAs. Each of 6 symptoms was assessed at each of the 4 time points during each EIA. Composite score at each time point was the sum of severity ratings for each of the 6 symptoms. Peak composite score (of the 3 post-alcohol initiation composite scores at each EIA test) was used as the subject's peak score for that EIA test. The point system was as follows: 0 point = symptom not present, 1 point = mild severity of symptom, 2 points = moderate severity of symptom and 3 points = severe severity of symptom. Participants were given a composite score, which was the sum of the scores of all 6 symptoms (highest possible score is 18).
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=4 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=4 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=4 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=4 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=8 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day 15
|
0.5 score on a scale
Standard Deviation 0.58
|
0.3 score on a scale
Standard Deviation 0.50
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0.3 score on a scale
Standard Deviation 0.76
|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day 29
|
0.8 score on a scale
Standard Deviation 0.96
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0.5 score on a scale
Standard Deviation 1.00
|
0.3 score on a scale
Standard Deviation 0.71
|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day 57
|
0.3 score on a scale
Standard Deviation 0.50
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0.1 score on a scale
Standard Deviation 0.35
|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day 85
|
0.3 score on a scale
Standard Deviation 0.58
|
1.0 score on a scale
Standard Deviation 1.41
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day 113
|
0.5 score on a scale
Standard Deviation 0.58
|
0.5 score on a scale
Standard Deviation 1.00
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0.2 score on a scale
Standard Deviation 0.41
|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day 169
|
0 score on a scale
Standard Deviation 0
|
0.5 score on a scale
Standard Deviation 1.00
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
0.3 score on a scale
Standard Deviation 0.49
|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day -1
|
0.8 score on a scale
Standard Deviation 0.96
|
1.3 score on a scale
Standard Deviation 1.50
|
1.0 score on a scale
Standard Deviation 1.41
|
0.3 score on a scale
Standard Deviation 0.50
|
0.3 score on a scale
Standard Deviation 0.46
|
|
Six Symptom Responses During Ethanol Interactions Assessments (EIAs)
Day 4
|
1.0 score on a scale
Standard Deviation 1.15
|
0 score on a scale
Standard Deviation 0
|
0.8 score on a scale
Standard Deviation 1.50
|
0.3 score on a scale
Standard Deviation 0.50
|
0.4 score on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Day -1, Day 4, Day 15, Day 29, Day 57, Day 85, Day 113 and Day 169Population: Pharmacodynamic Population (PP) included all participants randomly assigned to study intervention and who received a full dose of study intervention and had sufficient data for at least 1 postdose PD assessment.
Maximum plasma concentration of acetaldehyde was measured to evaluate the pharmacodynamic effects of ALDH2 reduction by DCR-AUD during serial EIAs days.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=4 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=4 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=4 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=4 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=8 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day -1
|
33.7 micromolar (μM)
Standard Deviation 13.5
|
26.7 micromolar (μM)
Standard Deviation 15.3
|
11.3 micromolar (μM)
Standard Deviation 6.91
|
15.4 micromolar (μM)
Standard Deviation 8.45
|
29.4 micromolar (μM)
Standard Deviation 48.6
|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day 4
|
30.9 micromolar (μM)
Standard Deviation 8.23
|
31.8 micromolar (μM)
Standard Deviation 24.2
|
10.3 micromolar (μM)
Standard Deviation 4.52
|
21.8 micromolar (μM)
Standard Deviation 13.8
|
31.9 micromolar (μM)
Standard Deviation 37.6
|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day 15
|
8.11 micromolar (μM)
Standard Deviation 12.5
|
6.52 micromolar (μM)
Standard Deviation 4.57
|
11.9 micromolar (μM)
Standard Deviation 11.2
|
11.0 micromolar (μM)
Standard Deviation 5.31
|
20.4 micromolar (μM)
Standard Deviation 28.2
|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day 29
|
13.4 micromolar (μM)
Standard Deviation 12.5
|
18.2 micromolar (μM)
Standard Deviation 8.31
|
25.6 micromolar (μM)
Standard Deviation 11.8
|
16.2 micromolar (μM)
Standard Deviation 9.48
|
10.6 micromolar (μM)
Standard Deviation 14.9
|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day 57
|
16.4 micromolar (μM)
Standard Deviation 8.38
|
18.6 micromolar (μM)
Standard Deviation 6.56
|
31.0 micromolar (μM)
Standard Deviation 14.9
|
22.3 micromolar (μM)
Standard Deviation 6.34
|
18.6 micromolar (μM)
Standard Deviation 23.3
|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day 85
|
12.8 micromolar (μM)
Standard Deviation 2.22
|
13.2 micromolar (μM)
Standard Deviation 4.87
|
26.5 micromolar (μM)
Standard Deviation 12.7
|
18.0 micromolar (μM)
Standard Deviation 4.30
|
8.38 micromolar (μM)
Standard Deviation 4.19
|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day 113
|
20.6 micromolar (μM)
Standard Deviation 7.63
|
15.5 micromolar (μM)
Standard Deviation 4.91
|
23.3 micromolar (μM)
Standard Deviation 15.5
|
27.0 micromolar (μM)
Standard Deviation 12.6
|
14.8 micromolar (μM)
Standard Deviation 14.7
|
|
Cmax: Maximum Observed Plasma Concentration of Acetaldehyde
Day 169
|
11.8 micromolar (μM)
Standard Deviation 3.51
|
23.5 micromolar (μM)
Standard Deviation 12.2
|
31.9 micromolar (μM)
Standard Deviation 17.5
|
13.5 micromolar (μM)
Standard Deviation 7.09
|
15.8 micromolar (μM)
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: Day -1, Day 4, Day 15, Day 29, Day 57, Day 85, Day 113 and Day 169Population: Pharmacodynamic Population (PP) included all participants randomly assigned to study intervention and who received a full dose of study intervention and had sufficient data for at least 1 postdose PD assessment.
Area under the concentration time curve from time 0 to fixed time 2.5 of acetaldehyde was measured to evaluate the pharmacodynamic effects of ALDH2 reduction by DCR-AUD during serial EIAs days.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=4 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=4 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=4 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=4 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=8 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day -1
|
44.4 hour*nanomolar (h*uM)
Standard Deviation 14.7
|
42.2 hour*nanomolar (h*uM)
Standard Deviation 27.2
|
10.3 hour*nanomolar (h*uM)
Standard Deviation 7.30
|
14.2 hour*nanomolar (h*uM)
Standard Deviation 11.5
|
39.1 hour*nanomolar (h*uM)
Standard Deviation 70.3
|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day 4
|
41.8 hour*nanomolar (h*uM)
Standard Deviation 18.4
|
48.4 hour*nanomolar (h*uM)
Standard Deviation 31.9
|
8.29 hour*nanomolar (h*uM)
Standard Deviation 7.04
|
24.2 hour*nanomolar (h*uM)
Standard Deviation 22.4
|
41.6 hour*nanomolar (h*uM)
Standard Deviation 55.9
|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day 15
|
4.18 hour*nanomolar (h*uM)
Standard Deviation 5.68
|
5.76 hour*nanomolar (h*uM)
Standard Deviation 3.95
|
11.7 hour*nanomolar (h*uM)
Standard Deviation 10.3
|
12.0 hour*nanomolar (h*uM)
Standard Deviation 9.88
|
21.3 hour*nanomolar (h*uM)
Standard Deviation 27.2
|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day 29
|
10.4 hour*nanomolar (h*uM)
Standard Deviation 10.2
|
24.9 hour*nanomolar (h*uM)
Standard Deviation 15.7
|
33.0 hour*nanomolar (h*uM)
Standard Deviation 13.6
|
23.9 hour*nanomolar (h*uM)
Standard Deviation 12.7
|
13.7 hour*nanomolar (h*uM)
Standard Deviation 23.0
|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day 57
|
25.3 hour*nanomolar (h*uM)
Standard Deviation 16.4
|
23.2 hour*nanomolar (h*uM)
Standard Deviation 11.2
|
32.6 hour*nanomolar (h*uM)
Standard Deviation 10.9
|
33.7 hour*nanomolar (h*uM)
Standard Deviation 13.1
|
25.9 hour*nanomolar (h*uM)
Standard Deviation 38.8
|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day 85
|
18.5 hour*nanomolar (h*uM)
Standard Deviation 9.05
|
14.8 hour*nanomolar (h*uM)
Standard Deviation 8.94
|
36.5 hour*nanomolar (h*uM)
Standard Deviation 19.4
|
28.2 hour*nanomolar (h*uM)
Standard Deviation 6.83
|
9.06 hour*nanomolar (h*uM)
Standard Deviation 5.49
|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day 113
|
28.0 hour*nanomolar (h*uM)
Standard Deviation 8.51
|
24.6 hour*nanomolar (h*uM)
Standard Deviation 13.4
|
28.6 hour*nanomolar (h*uM)
Standard Deviation 19.4
|
47.7 hour*nanomolar (h*uM)
Standard Deviation 23.3
|
21.7 hour*nanomolar (h*uM)
Standard Deviation 26.1
|
|
AUC0-2.5: Area Under the Concentration Time Curve From Time 0 to Fixed Time 2.5 of Acetaldehyde
Day 169
|
13.1 hour*nanomolar (h*uM)
Standard Deviation 4.74
|
37.7 hour*nanomolar (h*uM)
Standard Deviation 25.4
|
42.2 hour*nanomolar (h*uM)
Standard Deviation 17.8
|
21.1 hour*nanomolar (h*uM)
Standard Deviation 7.51
|
21.0 hour*nanomolar (h*uM)
Standard Deviation 39.8
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 169Population: Pharmacodynamic Population (PP) included all participants randomly assigned to study intervention and who received a full dose of study intervention and had sufficient data for at least 1 postdose PD assessment. Here, Overall Number of Participants Analyzed" signifies participants with available data for this outcome measure.
Heart rate is measured to evaluate the PD effects of ALDH2 reduction by DCR-AUD during serial EIA. Heart rate was monitored by telemetry during the EIAs.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=4 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=4 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=4 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=4 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=7 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Heart Rate
|
10.0 beats/min
Standard Deviation 1.83
|
17.0 beats/min
Standard Deviation 10.23
|
13.0 beats/min
Standard Deviation 3.65
|
11.5 beats/min
Standard Deviation 11.47
|
18.4 beats/min
Standard Deviation 16.22
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 169Population: Pharmacodynamic Population (PP) included all participants randomly assign ed to study intervention and who received a full dose of study intervention and had sufficient data for at least 1 postdose PD assessment. Here, Overall Number of Participants Analyzed" signifies participants with available data for this outcome measure.
Change in facial skin temperature was measured to evaluate the PD effects of ALDH2 reduction by DCR-AUD during serial EIAs for the expanded group. Facial skin temperature was measured using a surface scanning thermometer.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=4 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=4 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=4 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=4 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=7 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Facial Skin Temperature
|
0.55 degree celsius
Standard Deviation 0.351
|
0.48 degree celsius
Standard Deviation 0.330
|
0.28 degree celsius
Standard Deviation 0.655
|
0.53 degree celsius
Standard Deviation 0.250
|
0.51 degree celsius
Standard Deviation 0.398
|
SECONDARY outcome
Timeframe: Baseline (Day -1), Day 169Population: Pharmacodynamic Population (PP) included all participants randomly assigned to study intervention and who received a full dose of study intervention and had sufficient data for at least 1 postdose PD assessment.
Subjective feelings of alcohol intoxication or intolerance is measured to evaluate the PD effects of ALDH2 reduction by DCR-AUD during serial EIAs. Participants' subjective experience of the effects of alcohol was assessed using the SEAS. The SEAS is a 14-item tool that allows participants to rate the subjective effects of alcohol. Participants rated the extent to which they were feeling (high/low arousal positive: relaxed, wobbly, lively, secure, woozy, fun, calm, dizzy, mellow, funny, talkative and high/low arousal negative: demanding, rude and aggressive) on an 11-point scale from (0 = not at all, 10 = extremely). higher values represent more effects.
Outcome measures
| Measure |
Cohort 1: DCR-AUD 80 mg
n=4 Participants
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=4 Participants
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=4 Participants
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort 4: DCR-AUD 960 mg
n=4 Participants
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=8 Participants
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Change From Baseline in Subjective Effects of Alcohol Scale (SEAS) Score
Low Arousal Positive
|
0.688 score on a scale
Standard Deviation 0.6575
|
0.500 score on a scale
Standard Deviation 1.3540
|
0 score on a scale
Standard Deviation 0
|
0.313 score on a scale
Standard Deviation 0.5543
|
0.406 score on a scale
Standard Deviation 0.5165
|
|
Change From Baseline in Subjective Effects of Alcohol Scale (SEAS) Score
High Arousal Negative
|
-0.335 score on a scale
Standard Deviation 0.6700
|
1.333 score on a scale
Standard Deviation 2.6650
|
0.915 score on a scale
Standard Deviation 1.6175
|
-0.083 score on a scale
Standard Deviation 0.1650
|
0 score on a scale
Standard Deviation 0.6157
|
|
Change From Baseline in Subjective Effects of Alcohol Scale (SEAS) Score
High Arousal Positive
|
0.938 score on a scale
Standard Deviation 1.2311
|
1.250 score on a scale
Standard Deviation 3.2404
|
0.313 score on a scale
Standard Deviation 0.4732
|
-1.125 score on a scale
Standard Deviation 0.8539
|
0.438 score on a scale
Standard Deviation 1.9491
|
|
Change From Baseline in Subjective Effects of Alcohol Scale (SEAS) Score
Low Arousal Negative
|
1.083 score on a scale
Standard Deviation 2.5766
|
2.500 score on a scale
Standard Deviation 1.5533
|
2.750 score on a scale
Standard Deviation 3.1806
|
0.168 score on a scale
Standard Deviation 1.4781
|
-0.543 score on a scale
Standard Deviation 1.4111
|
Adverse Events
Cohort 1: DCR-AUD 80 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: DCR-AUD 240 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 3: DCR-AUD 480 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort :4 DCR-AUD 960 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: DCR-AUD 80 mg
n=6 participants at risk
Participant received a single dose of DCR-AUD 80 mg, subcutaneous injection on Day 1.
|
Cohort 2: DCR-AUD 240 mg
n=6 participants at risk
Participant received a single dose of DCR-AUD 240 mg, subcutaneous injection on Day 1.
|
Cohort 3: DCR-AUD 480 mg
n=6 participants at risk
Participant received a single dose of DCR-AUD 480 mg, subcutaneous injection on Day 1.
|
Cohort :4 DCR-AUD 960 mg
n=6 participants at risk
Participant received a single dose of DCR-AUD 960 mg, subcutaneous injection on Day 1.
|
Pooled Placebo
n=12 participants at risk
Participant received a single dose of DCR-AUD matching placebo, subcutaneous injection on Day 1.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
2/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
66.7%
4/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
General disorders
Injection site pain
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
2/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
0.00%
0/6 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
8.3%
1/12 • From Day 1 until end of the study (24 weeks).
Safety population included all participants randomly assigned to study intervention and who received the full dose of study intervention. All serious and non-serious adverse events presented here are treatment emergent adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee SPONSOR agrees that the Principal Investigator shall have the right to publish or permit the publication of any information or material relating to or arising out of the work after prior submittal to SPONSOR provided that if SPONSOR shall so request, the investigator will delay publication for a maximum of ninety (90) days after submittal to SPONSOR to enable SPONSOR to protect its rights. SPONSOR will comment on such documents within thirty (30) days.
- Publication restrictions are in place
Restriction type: OTHER