NCT03285620

A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants

A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered AL-034 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation (Part 1) and After Multiple Ascending Doses (Part 2) in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose administration of AL-034 in healthy adult participants. The aim is to examine the safety (including pharmacodynamic \[PD\] biomarker assessments), tolerability, and pharmacokinetics (PK) of increasing single ascending doses (SADs) (Part 1) and multiple ascending doses (MADs) (Part 2) of AL-034. The potential food effect will be investigated in healthy adult participants at one or optionally 2 single dose level(s).

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	AL-034	Participants will receive single oral dose of AL-034 under fed or fasted conditions in part 1 and part 2
DRUG	Placebo	Participants will receive single oral dose of matching placebo (oral solution) under fed or fasted conditions in part 1 and part 2.

Timeline

• Start date: 2017-09-07
• Primary completion: 2018-11-14
• Completion: 2018-11-14
• First posted: 2017-09-18
• Last updated: 2025-02-03

Locations

1 site across 1 country: New Zealand