NCT05233085

A Safety Study of AZD4041 in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of AZD4041 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Opioid Use Disorder (OUD)

Interventions

Type	Name	Description
DRUG	AZD4041	Participants will receive oral solution of AZD4041 as stated in arm description.
OTHER	Placebo	Participants will receive oral solution of placebo as stated in arm description.

Timeline

• Start date: 2021-12-17
• Primary completion: 2022-06-07
• Completion: 2022-06-07
• First posted: 2022-02-10
• Last updated: 2023-11-27
• Results posted: 2023-11-27

Locations

1 site across 1 country: Canada