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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
Research Site
Chandler, Arizona, United States
Research Site
Montclair, California, United States
Research Site
Hialeah, Florida, United States
Research Site
Port Orange, Florida, United States
Number of subjects with adverse events (AEs)
AEs will be collected at all sites visits per SOA.
Time frame: Up to and including week 19 (from pre-screening to follow-up visit)
Number of subjects with serious adverse events (SAEs)
SAEs will be reported and collected as they occur.
Time frame: Up to and including week 18 (from pre-screening to final visit).
Maximum observed plasma drug concentration (Cmax)
PK parameters to be collected per the SOA.
Time frame: Day 1 to Day 127
Area under the concentration-time curve from time 0 to infinity (AUCinf) for plasma PK
PK parameters to be collected per the SOA.
Time frame: Day 1 to 127
Area under the concentration-time curve over the dosing interval (AUCtau) for plasma PK
PK parameters to be collected per the SOA.
Time frame: Time frame: Day 1 to 127
Fraction of the dose excreted unchanged into the urine from time t1 to t2 (fe(t1-t2)) for urine PK
PK parameters to be collected per the SOA.
Time frame: Day 1 and Day 57: Pre-dose and between 0-6 hours, 6-12 hours, 12-24 hours, 24-36 hours and 36-48 hours post-dose
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Research Site
Atlanta, Georgia, United States
Research Site
Morehead City, North Carolina, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
San Juan, Puerto Rico