RecruitingPhase 1NCT05945537

A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH

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 Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Sponsor

Inipharm Australia Pty Ltd

Enrollment

168 participants

Start Date

Sep 8, 2023

Study Type

INTERVENTIONAL

Conditions

Metabolic Dysfunction-Associated 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, D and F and in participants with a history of MASH or presumed MASH in Part C and in participants with MASH in E.

Eligibility

Min Age: 18 YearsMax Age: 70 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(11)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Campbelltown Hospital, Level 10, building A, Campbelltown Hospital, Therry Road,

Campbelltown, New South Wales (nsw), Australia

Genesis Research Services, Ground Floor, 239/245 Denison Street Broadmeadow

Newcastle, New South Wales (nsw), Australia

Ramsay Health North Shore, North Shore Private, 03 Westbourne Street

Saint Leonards, New South Wales (nsw), Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

University of the Sunshine Coast Clinical Trials (Birtinya), UniSC Clinical Trials Vitality Village, Level 4, Tenancy 410, 5 Discovery Court

Birtinya, Queensland (qld), Australia

Flinders Medical Centre, Flinders Medical Centre, Flinders

Bedford Park, South Australia (SA), Australia

Box Hill Hospital, Level 1, 5 Arnold street

Box Hill, Victoria, Australia

St. Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

TrialsWest Pty Ltd, 90 Anstruther Road

Mandurah, Western Australia (WA), Australia

Westmead Hospital, Storr Liver Centre, Level 2, A/B Block, Westmead Hospital Corner Hawkesbury and Darcy Roads

Westmead, Westmead, Australia

View Full Details on ClinicalTrials.gov

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NCT05945537

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