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

NCT06703658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-02
Primary Completion
2025-03-13
Completion
2025-03-13

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06703658 on ClinicalTrials.gov