A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection
Summary
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3). Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)
Timeline
- Start
- 2017-07-07
- Primary completion
- 2017-09-18
- Completion
- 2017-09-18
Outcome
Outcome not reported
Stopped (Business): “Strategic decision to discontinue further development of investigational compounds for the treatment of hepatitis C.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AL-611 | Unknown | — | Oral |