A study to investigate Safety, Tolerability, and Pharmacokinetics of AZD7503 in participants with suspected NASH.
Study identifier:D9230C00002
ClinicalTrials.gov identifier:NCT05864391
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A Phase I randomized single-blind placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of AZD7503 following multiple ascending dose administration to patients with suspected non-cirrhotic non-alcoholic steatohepatitis (NASH)
Medical condition
Steatohepatitis
Phase
Phase 1
Healthy volunteers
No
Study drug
AZD7503
Sex
All
Estimated Enrollment
60
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 31 Mar 2023
Estimated Primary Completion Date: 08 Jan 2024
Estimated Study Completion Date: 25 Oct 2024
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Other: Cohort 1 Dose A cohort: 20 participants; n=15 on AZD7503 dose A, n=5 on Placebo | Drug: AZD7503 Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 28 days, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection. |
| Other: Cohort 2 Dose B cohort: 20 participants; n=15 on AZD7503 dose B, n=5 on Placebo. | Drug: AZD7503 Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 28 days, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection. |
| Other: Cohort 3 Dose C cohort: 20 participants n=15 on AZD7503 dose C, n=5 on Placebo. | Drug: AZD7503 Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 28 days, a 12-week study intervention period, and a follow-up visit at week 18 (10 weeks following the final dose). Participants will be randomly assigned in a 3:1 ratio to receive AZD7503 or placebo. Study intervention will be administered via subcutaneous injection. |
