Trial Outcomes & Findings for Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH (NCT NCT04202354)
NCT ID: NCT04202354
Last Updated: 2025-10-03
Results Overview
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
From first dose of study drug through Day 113 (±5 days)
Results posted on
2025-10-03
Participant Flow
Following Screening, Cohorts 1 through 4 (normal healthy volunteers) enrolled eligible participants, randomly assigned 1:1 to receive a single subcutaneous (SC) dose of ARO-HSD or placebo on Day 1. Per protocol, the placebo cohorts were pooled for data analysis.
Participant milestones
| Measure |
Cohort 1: ARO-HSD 25 mg
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
16
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
16
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of ARO-HSD in Healthy Volunteers and Patients With Non-Alcoholic Steatohepatitis (NASH) or Suspected NASH
Baseline characteristics by cohort
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
n=16 Participants
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
n=6 Participants
Participants with suspected NASH receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
n=6 Participants
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
n=6 Participants
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
50 Participants
n=114 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
21 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
29 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
18 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
23 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
47 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through Day 113 (±5 days)Population: Safety Population: all enrolled participants who received at least one dose of active drug or placebo.
Adverse event (AE)=any untoward medical occurrence that does not necessarily have to have a causal relationship with this treatment. TEAEs=AEs with onset after administration of the study drug, or when a pre-existing medical condition increases in severity or frequency after study drug administration. Serious adverse event (SAE)= an AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
n=16 Participants
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
n=6 Participants
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
n=6 Participants
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
n=6 Participants
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Possibly or Probably Related to Treatment
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Normal Healthy Volunteers: Day 1: 2 hours pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 18, 24; Day 2: 48 hours post-dose, Days 8, 15, 29. NASH Participants: Day 1: 2 hours pre-dose, 30 minutes, 1, 2, 24, hours post-dose, Days 8, 15, 29Population: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Participants with sufficient data at given time point.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
n=6 Participants
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
n=6 Participants
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
n=6 Participants
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
Day 29
|
—
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
2 hours pre-dose
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
15 minutes post-dose
|
56.7555 ng/mL
Standard Deviation 13.2117
|
60.7480 ng/mL
Standard Deviation 52.6374
|
101.4768 ng/mL
Standard Deviation 66.7517
|
275.6855 ng/mL
Standard Deviation 261.1693
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
30 minutes post-dose
|
67.6780 ng/mL
Standard Deviation 13.9394
|
116.6108 ng/mL
Standard Deviation 70.4360
|
160.9810 ng/mL
Standard Deviation 72.2119
|
445.7370 ng/mL
Standard Deviation 316.1025
|
22.13370 ng/mL
Standard Deviation 8.3169
|
123.2292 ng/mL
Standard Deviation 11.5639
|
174.1368 ng/mL
Standard Deviation 127.8926
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
1 hour post-dose
|
66.6098 ng/mL
Standard Deviation 14.6623
|
134.8668 ng/mL
Standard Deviation 66.4452
|
211.1088 ng/mL
Standard Deviation 78.3225
|
531.6415 ng/mL
Standard Deviation 213.0969
|
29.3950 ng/mL
Standard Deviation 8.2373
|
158.0703 ng/mL
Standard Deviation 36.7514
|
251.3230 ng/mL
Standard Deviation 133.5201
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
2 hours post-dose
|
53.5845 ng/mL
Standard Deviation 9.4115
|
137.1443 ng/mL
Standard Deviation 53.1775
|
219.4920 ng/mL
Standard Deviation 108.8893
|
510.3820 ng/mL
Standard Deviation 146.3129
|
26.4290 ng/mL
Standard Deviation 7.2923
|
166.2240 ng/mL
Standard Deviation 45.4507
|
286.9603 ng/mL
Standard Deviation 103.4747
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
4 hours post-dose
|
60.8553 ng/mL
Standard Deviation 4.2935
|
157.5515 ng/mL
Standard Deviation 64.5494
|
253.6468 ng/mL
Standard Deviation 91.5590
|
542.9808 ng/mL
Standard Deviation 80.1204
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
8 hours post-dose
|
53.9558 ng/mL
Standard Deviation 12.2129
|
136.8678 ng/mL
Standard Deviation 49.6823
|
255.7058 ng/mL
Standard Deviation 27.2111
|
534.2020 ng/mL
Standard Deviation 56.0211
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
12 hours post-dose
|
33.7875 ng/mL
Standard Deviation 6.5592
|
80.2873 ng/mL
Standard Deviation 26.8625
|
180.7433 ng/mL
Standard Deviation 54.0979
|
363.3568 ng/mL
Standard Deviation 35.9755
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
18 hours post-dose
|
12.5088 ng/mL
Standard Deviation 5.5194
|
17.7438 ng/mL
Standard Deviation 12.6477
|
75.3893 ng/mL
Standard Deviation 32.1815
|
176.4455 ng/mL
Standard Deviation 41.8914
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
24 hours post-dose
|
2.0123 ng/mL
Standard Deviation 1.7888
|
2.9088 ng/mL
Standard Deviation 2.3774
|
20.6793 ng/mL
Standard Deviation 12.8362
|
65.4435 ng/mL
Standard Deviation 28.6583
|
6.7428 ng/mL
Standard Deviation 4.3051
|
25.5277 ng/mL
Standard Deviation 9.0820
|
84.2982 ng/mL
Standard Deviation 28.8905
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
48 hours post-dose
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
1.8418 ng/mL
Standard Deviation 1.2854
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
Day 8
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
—
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
—
|
|
Pharmacokinetics (PK) of ARO-HSD: Plasma Concentrations
Day 15
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
0.0000 ng/mL
Standard Deviation 0.0000
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
PK of ARO-HSD in Normal Healthy Volunteers: Maximum Observed Plasma Concentration (Cmax)
|
74.0 ng/mL
Standard Deviation 11.5
|
184 ng/mL
Standard Deviation 52.2
|
294 ng/mL
Standard Deviation 60.3
|
644 ng/mL
Standard Deviation 183
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
PK of ARO-HSD in Normal Healthy Volunteers: Time to Reach Cmax (Tmax)
|
2.5 hours
Interval 0.5 to 8.0
|
3.0 hours
Interval 0.5 to 8.0
|
8.0 hours
Interval 4.0 to 8.0
|
3.0 hours
Interval 0.5 to 8.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
PK of ARO-HSD in Normal Healthy Volunteers: Terminal Elimination Half-Life (t1/2)
|
3.3 hours
Standard Deviation 0.90
|
2.5 hours
Standard Deviation 0.6
|
3.7 hours
Standard Deviation 0.9
|
4.5 hours
Standard Deviation 0.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Concentration-Time Curve From Dosing (Time 0) to the Time of the Last Measured Concentration (AUClast)
|
788 h*ng/mL
Standard Deviation 43.5
|
1830 h*ng/mL
Standard Deviation 346
|
3670 h*ng/mL
Standard Deviation 549
|
8450 h*ng/mL
Standard Deviation 479
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
PK of ARO-HSD in Normal Healthy Volunteers: Area Under the Curve From Time 0 to Infinity (AUCinf)
|
806 h*ng/mL
Standard Deviation 38.4
|
1840 h*ng/mL
Standard Deviation 343
|
3790 h*ng/mL
Standard Deviation 587
|
8500 h*ng/mL
Standard Deviation 506
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Secondary: PK of ARO-HSD in Normal Healthy Volunteers: Oral Clearance (CL/F)
|
31.1 L/hour
Standard Deviation 1.48
|
27.9 L/hour
Standard Deviation 4.96
|
26.8 L/hour
Standard Deviation 3.65
|
23.6 L/hour
Standard Deviation 1.43
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24, 48 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
PK of ARO-HSD in Normal Healthy Volunteers: Apparent Volume of Distribution During the Terminal-Phase (Vz/F)
|
148 L
Standard Deviation 38.7
|
99.9 L
Standard Deviation 29.3
|
141 L
Standard Deviation 37.6
|
153 L
Standard Deviation 27.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Urine PK of ARO-HSD in Normal Healthy Volunteers: Amount of Unchanged Drug Recovered in Urine Over 0-24 Hours Postdose (Ae0-24h)
|
1.56 mg
Standard Deviation 0.12
|
3.64 mg
Standard Deviation 0.75
|
6.67 mg
Standard Deviation 3.21
|
45.8 mg
Standard Deviation 9.66
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Urine PK of ARO-HSD in Normal Healthy Volunteers: Percentage of the Administrated Drug Recovered in Urine Over 0-24 Hours (Fe0-24h)
|
6.23 percentage of study drug
Standard Deviation 0.47
|
7.29 percentage of study drug
Standard Deviation 1.50
|
6.67 percentage of study drug
Standard Deviation 3.21
|
22.9 percentage of study drug
Standard Deviation 4.83
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 15 minutes, 30 minutes, 1, 2, 4, 8 12, 18, 24 hours postdosePopulation: PK Analysis Set: all participants who received at least one dose of active study treatment and had sufficient plasma concentration data to characterize PK profile. Normal healthy volunteer cohorts only.
Outcome measures
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 100 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 Participants
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohorts 1-4: Pooled Placebo
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Urine PK of ARO-HSD in Normal Healthy Volunteers: Renal Clearance (CLr)
|
1.97 L/hour
Standard Deviation 0.14
|
1.99 L/hour
Standard Deviation 0.17
|
1.82 L/hour
Standard Deviation 0.88
|
5.75 L/hour
Standard Deviation 1.43
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort 1: ARO-HSD 25 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: ARO-HSD 50 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: ARO-HSD 100 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 4: ARO-HSD 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohorts 1-4: Pooled Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 1b: ARO-HSD 25 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3b: ARO-HSD 100 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4b: ARO-HSD 200 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD ≤ 200 mg on Day 1 only
|
Cohorts 1-4: Pooled Placebo
n=16 participants at risk
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
n=6 participants at risk
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
n=6 participants at risk
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
n=6 participants at risk
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
Other adverse events
| Measure |
Cohort 1: ARO-HSD 25 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD 25 mg on Day 1 only.
|
Cohort 2: ARO-HSD 50 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD 50 mg on Day 1 only.
|
Cohort 3: ARO-HSD 100 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD 200 mg on Day 1 only.
|
Cohort 4: ARO-HSD 200 mg
n=4 participants at risk
Normal healthy volunteers randomized to double blind ARO-HSD ≤ 200 mg on Day 1 only
|
Cohorts 1-4: Pooled Placebo
n=16 participants at risk
Normal healthy volunteers randomized to double blind placebo on Day 1 only.
|
Cohort 1b: ARO-HSD 25 mg
n=6 participants at risk
Participants with suspected non-alcoholic steatohepatitis (NASH) receive open-label ARO-HSD 25 mg on Days 1 and 29.
|
Cohort 3b: ARO-HSD 100 mg
n=6 participants at risk
Participants with suspected NASH receive open-label ARO-HSD 100 mg on Days 1 and 29.
|
Cohort 4b: ARO-HSD 200 mg
n=6 participants at risk
Participants with suspected NASH received open-label ARO-HSD 200 mg on Days 1 and 29.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Blood and lymphatic system disorders
Blood creatine phosphokinase increased
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Dental caries
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Cardiac disorders
Palpitations
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Eye disorders
Blepharospasm
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Morning sickness
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
General disorders
Injection site bruising
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
General disorders
Injection site erythema
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
50.0%
2/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
General disorders
Injection site swelling
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
General disorders
Medical device site reaction
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
General disorders
Chest pain
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Injury, poisoning and procedural complications
Nerve injury
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
16.7%
1/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
6.2%
1/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
0.00%
0/4 • Screening through Day 113 (±5 days)
|
25.0%
1/4 • Screening through Day 113 (±5 days)
|
0.00%
0/16 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
0.00%
0/6 • Screening through Day 113 (±5 days)
|
Additional Information
Chief Operating Officer
Arrowhead Pharmaceuticals, Inc.
Phone: 1 (626) 304-3400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).
- Publication restrictions are in place
Restriction type: OTHER