Trials / Terminated
TerminatedNCT04565717
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 3-Part Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-HSD in Healthy Adult Subjects and Multiple Dose ALN-HSD in Adult Patients With Nonalcoholic Steatohepatitis (NASH)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Alnylam Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-HSD in healthy participants (Part A) and multiple doses of ALN-HSD in patients with NASH (Parts B and C).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALN-HSD | ALN-HSD will be administered by subcutaneous (SC) injection. |
| DRUG | Placebo | Normal saline (0.9% NaCl) matching volume of ALN-HSD doses will be administered SC. |
Timeline
- Start date
- 2020-10-09
- Primary completion
- 2023-01-06
- Completion
- 2023-12-21
- First posted
- 2020-09-25
- Last updated
- 2024-05-17
Locations
13 sites across 5 countries: United States, Belgium, Bulgaria, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04565717. Inclusion in this directory is not an endorsement.