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 Dec 2024 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 |