NCT05945537

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Inipharm Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will consist of 4 parts: Approximately 104 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). * In Part D (SAD), approximately 8 healthy adult participants are planned to be enroled in 1 Cohort of 8 participants.

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	INI-822 (A)	Different dose levels of INI-822
OTHER	Placebo (B)	Matching placebo to INI-822

Timeline

• Start date: 2023-09-08
• Primary completion: 2025-05-15
• Completion: 2025-06-15
• First posted: 2023-07-14
• Last updated: 2025-02-05

Locations

7 sites across 1 country: Australia