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

Non-alcoholic Steatohepatitis Clinical Trial

Official title:
A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH) or Presumed NASH

Clinical Trial 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 and B and in participants with a history of NASH or presumed NASH in Part C.

Clinical Trial Description

The study will consist of 3 parts: Approximately 96 participants are planned to be enroled into the study. - In Part A (SAD), approximately 48 healthy adult participants are planned to be enroled in 6 cohorts of 8 participants each (Cohorts A1 to A6, including one fasted:fed crossover cohort to assess food effect). - In Part B (MAD), approximately 24 healthy adult participants are planned to be enroled in 3 cohorts of 8 participants each (Cohorts B1 to B3). - In Part C (Pharmacodynamics), approximately 24 participants with NASH or presumed NASH are planned to be enroled in 2 cohorts of 12 participants each (Cohorts C1 to C2). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05945537
Study type Interventional
Source Inipharm Australia Pty Ltd
Contact Katelyn Patterson
Phone +1 209-402-1568
Email kpatterson@inipharm.com
Status Recruiting
Phase Phase 1
Start date September 8, 2023
Completion date July 28, 2024
View Details
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