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

Study identifier:D7260C00004

ClinicalTrials.gov identifier:NCT06555822

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Healthy Participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD5004, Placebo

Sex

All

Actual Enrollment

31

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 15 Aug 2024
Estimated Primary Completion Date: 27 Feb 2025
Estimated Study Completion Date: 27 Feb 2025

Study design

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

Verification:

Verified 01 Dec 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria