Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis

Status Recruiting

Clinical Trial Summary

This study is a Phase 1, first-in-human single-dose escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.

Clinical Trial Description

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose (SAD) in participants with suspected or confirmed diagnosis of noncirrhotic nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) without advanced hepatic fibrosis. This dose-escalating strategy will test the safety of OA-235i when given as a single subcutaneous dosage using up to five successive cohorts. Each cohort will have three non-randomized participants receiving the active medication. One (1) planned multiple dose (MD) expansion dose cohort with 8 NAFLD/NASH subjects will be enrolled for a 7-day dosing regimen at a dose level to be determined from the SAD portion of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05680233
Study type	Interventional
Source	Oasis Pharmaceuticals, LLC
Contact	Manal Abdelmalek, MD
Phone	507-284-2511
Email	Abdelmalek.manal@mayo.edu
Status	Recruiting
Phase	Phase 1
Start date	January 23, 2023
Completion date	April 2024

View Details

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