Study identifier:D9230C00002
ClinicalTrials.gov identifier:NCT05864391
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Steatohepatitis
Phase 1
No
AZD7503
All
40
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2024 by AstraZeneca
AstraZeneca
-
The purpose of this study is to measure the safety, tolerability, and PK (measurement of drug activity in the body over time) of AZD7503 injected subcutaneously, and compared to placebo, in participants with suspected NASH, a type of liver disease.
This is a Phase I, randomised, single-blind (in which the study centre staff including the Principal Investigator, remain blinded during the clinical conduct of a given cohort) placebo controlled, multiple ascending dose (MAD) study in male and female participants conducted at multiple centres. Each participant is expected to be in the study for approximately 24 weeks, including a screening period of up to 4 weeks, 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.
Location
Location
San Antonio, TX, United States, 78229
Location
Montclair, CA, United States, 91763
Location
Port Orange, FL, United States, 32127
Location
Chandler, AZ, United States, 85224
Location
San Antonio, TX, United States, 78215
Location
Morehead City, NC, United States, 28557
Location
Hialeah, FL, United States, 33016
Location
Atlanta, GA, United States, 30349
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. |
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