Status: Recruiting
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, D and F and in participants with a history of MASH or presumed MASH in Part C and in participants with MASH in E.
Participants needed: 168
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Inipharm Australia Pty LtdUpdated: Aug 3, 2026Locations: 11
Eligibility criteria
Females must not be pregnant or lactating, and must use acceptable, highly effec... [+16]
An underlying physical or psychological medical condition that, in the opinion o... [+47]