SZN 043 in participants with severe alcohol-associated hepatitis
Research type
Research Study
Full title
A Phase 1b study evaluating safety and pharmacokinetics of SZN 043 in participants with severe alcohol-associated hepatitis
IRAS ID
1009585
Contact name
Prerna Menon
Contact email
Sponsor organisation
Surrozen Operating, Inc.
ISRCTN Number
ISRCTN55168173
Research summary
SZN-043 is being developed to learn how safe and effective this medication is in treating Severe alcohol-associated hepatitis (sAH). SZN-043 is being tested in another research study in healthy volunteers and in people with liver cirrhosis (scarring of the liver). This is the first time that SZN-043 is being tested in people with sAH.
This study will enroll approximately 18 participants in approximately 5 countries for approximately 1 year.
Blood, urine, and tissue samples will be collected, for routine safety and study-related tests.
Participants will be assigned to one of 3 treatment groups, which will include at least 6 participants each. The treatment groups will differ by the number of doses participants will receive and the strength of those doses. Participants may receive either 1 (Day 0), 2 (Days 0 and 4), or 3 (Days 0, 4, and 7) doses of the study medication depending on their treatment group and how the study progresses.
The study medication will be administered in the hospital via Intravenous infusion (IV) that will take approximately 30 minutes. Participants will be observed for at least 4 hours after receiving study medication.
This research study could be done while participants are in either inpatient or outpatient care. Once participants have completed inpatient treatment, outpatient treatment can occur in a clinic within the hospital or at a similar location.
Participants will be required to attend the study visits, including a screening period and dosing days.
Some procedures would typically be conducted as a part of normal care, the main difference between regular care and this study is that participants will receive the study medication, additional blood work will be completed, and participants will have study-specific tests to assess liver function, and they will be asked to complete a questionnaire.
The study is paid for by Surrozen Operating, Inc., the sponsor of this study.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0239
Date of REC Opinion
2 May 2024
REC opinion
Further Information Favourable Opinion