RecruitingPhase 1NCT05945537

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

Sponsor

Inipharm Australia Pty Ltd

Enrollment

104 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

Non Alcoholic Steatohepatitis

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called INI-822 (A) and Placebo (B) for people with non alcoholic steatohepatitis. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINI-822 (A)

Different dose levels of INI-822

OTHERPlacebo (B)

Matching placebo to INI-822

Locations(7)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

CMAX Clinical Research

Adelaide, South Australia, Australia

The Queen Elizabeth Hospital

Woodville, South Australia, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT05945537

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