Study identifier:D7260C00004
ClinicalTrials.gov identifier:NCT06555822
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Participants
Phase 1
Yes
AZD5004, Placebo
All
31
Interventional
18 Years - 55 Years
Allocation: Randomized 
Endpoint Classification: - 
Intervention Model: Parallel Assignment 
Masking: - 
Primary Purpose: Treatment 
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
No locations available
| Arms | Assigned Interventions | 
|---|---|
| Experimental: Part A: Multiple Ascending dose (MAD) (AZD5004) Participants will receive repeated dosing of AZD5004 orally.  | Drug: AZD5004  Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned. Other Name: ECC5004  | 
| Placebo Comparator: Part A: Placebo Participants will receive matching Placebo orally.  | Drug: Placebo  Placebo will be administered as an oral tablet once daily.  | 
| Experimental: Part B: Treatment 1 (AZD5004) Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.  | Drug: AZD5004  Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned. Other Name: ECC5004  | 
| Experimental: Part B: Treatment 2 (AZD5004) Participants in Group 1 will receive Treatment 1 of AZD5004 and then Treatment 2 of AZD5004. Participants in Group 2 will receive Treatment 2 of AZD5004 and then Treatment 1 of AZD5004.  | Drug: AZD5004  Participants will receive oral tablets of AZD5004 in Part A and Part B of the study as per arms they are assigned. Other Name: ECC5004  |