NCT05680233

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

A Phase 1a/1b Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OA-235i, a PAR2 Inhibitor, in Adults With Nonalcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Oasis Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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) randomized, placebo-controlled expansion cohort with 9 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.

Conditions

• Nonalcoholic Steatohepatitis
• Nonalcoholic Fatty Liver

Interventions

Type	Name	Description
DRUG	OA-235i (4 mg)	3 participants will receive 4 mg as a single subcutaneous dose
DRUG	OA-235i (8 mg)	3 participants will receive 8 mg as a single subcutaneous dose
DRUG	OA-235i (16 mg)	3 participants will receive 16 mg as a single subcutaneous dose
DRUG	OA-235i (30 mg)	3 participants will receive 30 mg as a single subcutaneous dose
DRUG	OA-235i (40 mg)	3 participants will receive 40 mg as a single subcutaneous dose
DRUG	OA-235i or placebo	9 participants will receive a daily subcutaneous dose of OA-235i or placebo for 7 consecutive days

Timeline

• Start date: 2023-03-06
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2023-01-11
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study