NCT06703658

A Study to Investigate Multiple Ascending Doses of AZD5004 in Healthy Japanese Participants and Participants With Type 2 Diabetes Mellitus

A Phase I, Randomised, Single-blind, Placebo-controlled, Single and Repeated Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5004 in Healthy Japanese Participants and With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This Phase I study will gather important information on the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5004 in both healthy Japanese participants and Japanese participants with T2DM.

Detailed description

This is a placebo-controlled study to assess the safety, efficacy, tolerability, and PK of single and 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. The study will comprise: 1. A Screening Period of maximum 28 days. 2. A Treatment Period of 1 day(Part A) or 105 days (Part B). 3. A final Follow-up Visit approximately 7 days(Part A) or 14 days(Part B) after the last study intervention administration.

Conditions

• Healthy Participants
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	AZD5004(Part A)	Single dose of AZD5004 oral on Day1
DRUG	Placebo(Part A)	Single dose of placebo oral on Day1
DRUG	AZD5004(Part B)	AZD5004 will be administered as an oral tablet once daily.
DRUG	Placebo(Part B)	Placebo will be administered as an oral tablet once daily.

Timeline

• Start date: 2024-11-02
• Primary completion: 2025-03-13
• Completion: 2025-03-13
• First posted: 2024-11-25
• Last updated: 2025-03-21

Locations

1 site across 1 country: Japan