At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating AL-034 and Placebo for Hepatitis B. Completed, enrolled 42 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Participants will receive single oral dose of AL-034 under fed or fasted conditions in part 1 and part 2
Participants will receive single oral dose of matching placebo (oral solution) under fed or fasted conditions in part 1 and part 2.