At a glance
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A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of AZD4041 in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating AZD4041 and Placebo for Opioid Use Disorder (OUD). Completed, enrolled 36 participants across 1 site.
Detailed Summary
This is a Phase 1, single-centre, randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study in healthy male and female adult participants. The study will include up to 48 participants (12 participants per cohort) who will be randomized 9:3 to active drug or placebo. Each cohort will receive AZD4041 or placebo in a MAD study. A sequential cohort MAD design will be employed to assure that higher doses are administered to healthy participants only after lower doses have demonstrated an acceptable safety profile. The total study duration will be up to 59 days (including Screening) per participant.
Study Details
Timeline
Interventions
Participants will receive oral solution of AZD4041 as stated in arm description.
Participants will receive oral solution of placebo as stated in arm description.