NCT06555822

A Study to Investigate Multiple Ascending Doses and Relative Bioavailability of AZD5004 in Healthy Participants

A Phase I, Two-Part Study in Healthy Volunteers Consisting of a Randomized, Single-blind, Placebo-controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5004 and a Randomized, Open-Label, Two-way Cross-over Study to Compare the Relative Bioavailability of Two Oral Tablet Strengths of AZD5004

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to assess the safety, tolerability, and pharmacokinetic (PK) of AZD5004 administered as multiple oral doses in healthy participants and to compare the relative bioavailability of two oral tablet strengths of AZD5004.

Detailed description

This study comprises of 2 parts - Part A and Part B. Part A is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of repeated dosing of AZD5004 compared with placebo. Participants who are eligible according to the inclusion/exclusion criteria will be randomized to receive AZD5004 or matching placebo. Part A will comprise: 1. A Screening Period of maximum 28 days. 2. A Treatment Period of 106 days. 3. A final Follow-up Visit approximately 14 days after the last study intervention administration. Part B is a two-way cross-over study to compare the relative bioavailability of 2 oral tablet strengths of Formulation 1 (F1) of AZD5004. The purpose of this study is to expand product knowledge between the 2 oral tablet strengths on plasma exposure levels to guide Phase 3 drug product development. The participants will be split into 2 groups. Group 1 will be dosed with Treatment 1 of AZD5004 and then dosed with Treatment 2 of AZD5004. Group 2 will be dosed with Treatment 2 of AZD5004 and then dosed with Treatment 1 of AZD5004. Part B of the study will comprise: 1. A Screening Period of maximum 28 days. 2. Two Treatment Periods, each consisting of 7 days. 3. A final Follow-up Visit approximately 6 days after the last dose of study intervention administration.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD5004	Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned.
DRUG	Placebo	Placebo will be administered as an oral tablet once daily.

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-03-06
• Completion: 2025-03-06
• First posted: 2024-08-15
• Last updated: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study