drugset / Trial / NCT05945537

A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH

NCT05945537 ↗

Phase 1 Recruiting 104 enrolled Inipharm Australia Pty Ltd
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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, and D and in participants with a history of NASH or presumed NASH in Part C.

Timeline

Start
2023-09-08
Primary completion
2025-05-15
Completion
2025-06-15

Drugs

EvaluationDrugModalityDoseRoute
Subject INI-822 Unknown — Oral