drugset
drugset / Trial / NCT05680233

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

NCT05680233 ↗

Phase 1 Completed 24 enrolled Oasis Pharmaceuticals, LLC Mayo Clinic · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
NaSequentialOpen-labelTreatment

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.

Timeline

Start
2023-03-06
Primary completion
2024-07-02
Completion
2024-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject OA-235i Unknown 4 mg Subcutaneous
Subject OA-235i Unknown 8 mg Subcutaneous
Subject OA-235i Unknown 16 mg Subcutaneous
Subject OA-235i Unknown 30 mg Subcutaneous
Subject OA-235i Unknown 40 mg Subcutaneous

Indications

NAFLD1 metabolic dysfunction-associated steatohepatitis