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

Study identifier:D7260C00003

ClinicalTrials.gov identifier:NCT06703658

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Healthy Participants, Type 2 Diabetes

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5004(Part A), Placebo(Part A), AZD5004(Part B), Placebo(Part B)

Sex

All

Actual Enrollment

35

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 02 Nov 2024
Estimated Primary Completion Date: 20 Apr 2025
Estimated Study Completion Date: 21 Apr 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2025 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria