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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Metabolic Dysfunction-Associated Steatohepatitis

In brief

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.

Key facts

Study ID

NCT05945537

Run by

Inipharm Australia Pty Ltd

People needed

168

Starts

2023-09-08

Expected to finish

2026-10-31

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception from Screening until 30 days after their last dose of IP or 5 half-lives, whichever is longer. Females with same-sex partners (abstinent from penile-vaginal intercourse) or who are abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Day -1. Women not of childbearing potential must be postmenopausal for ≥ 12 months (postmenopausal status is to be confirmed through testing of follicle stimulating hormone [FSH] levels ≥ 40 IU/L at Screening for amenorrhoeic female participants). Females must not donate ova from the first dose of IP until at least 30 days after the last dose of IP.
• Males must be surgically sterile (> 30 days since vasectomy [documented evidence] with no viable sperm), or, if engaged in sexual relations with a WOCBP, they must use a condom and either his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), or an acceptable, highly effective contraceptive method must be used from Day -1 until at least 30 days after the last dose of IP. Males with same-sex partners (abstinent from penile-vaginal intercourse) or abstinent from heterosexual intercourse are not required to use contraception when this is their preferred and usual lifestyle. Males must not donate sperm from the first dose of IP until at least 30 days after the last dose of IP.
• Able and willing to attend the necessary visits to the study site.
• Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
• Normal renal function (estimated glomerular filtration rate > 60 mL/min using Cockcroft-Gault) at Screening and Day -1 Visits.
• For Parts A and B, D, and F only:
• Clinical laboratory values within normal range at Screening and Day -1 and Day 7 (Part D), as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or designee. Any laboratory values > upper limit of normal (ULN) at Screening should be discussed with the Sponsor, independent MM, or Investigator for approval prior to inclusion. Repeat testing at Screening is acceptable for out-of-range values following approval by the Investigator or designee. Inclusion of participants with laboratory values > ULN at Day -1 and Day 7 (Part D) will be at the Investigator's discretion.
• In good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at Screening and/or before the first administration of IP, at the discretion of the Investigator or designee.
• Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 with a maximum body weight of 120 kg.
• 18 to 55 years of age (inclusive at the time of informed consent).
• Able and willing to refrain from use of tobacco and other nicotine-containing products while at the study site and through the study treatment period.
• For Part C only:
• 18 to 65 years of age (inclusive at the time of informed consent).
• A diagnosis of MASH confirmed by 1 or more of the following:
• Historical liver biopsy consistent with MASH (presence of Grade 1 steatosis, hepatocellular ballooning, and lobular inflammation) according to the non-alcoholic fatty liver disease (MAFLD) activity score.
• F0-3 fibrosis according to the MASH Clinical Research Network classification within 1 year of Screening.
• A clinical diagnosis of MASH, and the presence of any component of the metabolic syndrome (obesity, dyslipidemia, hypertension, elevated fasting glucose, or type 2 diabetes).
• FibroScan-aspartate aminotransferase (FAST) score more than equal to 0.35.
• Alanine aminotransferase (ALT) > 1.00 × ULN at 2 separate time points in the past 6 months. At least 1 time point must be at Screening and the values must be at least 2 weeks apart. Patients with ALT values <1.00 × ULN may be included in the study on a case-by-case basis after approval by the Sponsor.
• Fibrosis-4 (FIB-4) score ≤ 2.67, controlled attenuation parameter (CAP) score by FibroScan® ≥ 280 Db/m, and liver stiffness measurement (LSM) by FibroScan® ≤ 14 kPa.
• No documented weight loss > 5% in the 6 months preceding Screening.
• If on glucagon-like peptide 1 (GLP1) agonists, sodium-glucose co-transporter 2 (SGLT2) inhibitors, or vitamin E (dose > 400 IU/day), then should have been on a stable dose for at least 3 months.
• Platelet count > 150,000 and albumin ≥ 35 g/L.
• BMI Greater than equals to 18.0 and ≤ 40.0 kg/m2
• For Part E only:

You may not qualify if…

• A participant who meets any of the following exclusion criteria must be excluded from the study:
• An underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely for the participant to comply with the protocol or complete the study per protocol.
• Blood donation or significant blood loss (> 500 mL) within 60 days prior to the first administration of IP.
• Plasma donation within 7 days prior to the first administration of IP.
• Fever (body temperature > 37.7°C) or symptomatic viral or bacterial infection within 2 weeks prior to Day 1.
• Dysphagia that would limit ability to swallow IP.
• History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents. The excipients in the IP are: Hydroxypropyl methylcellulose Acetate Succinate (HPMCAS), Microcrystalline Cellulose, Micronized Poloxamer 407 (polyoxyethylene oxide), Croscarmellose Sodium, Silicon Dioxide, Magnesium Stearate, and Hydroxypropylmethylcellulose capsules containing Titanium Oxide.
• Abnormalities in physical examination at Screening and Day -1 which are deemed clinically significant by the Investigator or designee.
• Abnormal electrocardiogram (ECG) measurements at Screening (an average of 3 readings) and Day -1 (single reading) that are considered by the Investigator or designee to be clinically significant, including corrected QT interval with Fridericia's correction (QTcF) > 450 msec (males) or > 470 msec (females).
• Unstable vital sign(s) or the following values seen at Screening or prior to dosing following 5 minutes of resting in the semi-supine position (an abnormal value may be repeated once, separated by at least 5 minutes, with both values documented). If there is a known medical reason for the abnormality, the timepoint may be repeated on a separate day:
• Systolic blood pressure < 90 mmHg or > 160 mmHg OR
• Diastolic blood pressure < 50 mmHg or > 95 mmHg OR
• Pulse rate < 45 beats per minute (bpm) or > 100 bpm.
• Presence of other clinically significant causes of active liver disease including genetic, autoimmune, viral, and alcoholic liver disease.
• Cirrhosis of the liver as defined by:
• A prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding OR
• F4 on previous liver biopsy OR
• Historical evidence of cirrhosis on liver imaging.
• History of major hospitalization or major surgery within 6 months prior to first IP administration. Sites are encouraged to confirm with the Sponsor or MM if there are any questions on what would be considered major hospitalization or major surgery.
• Infections requiring parenteral antibiotics within 6 months prior to first IP administration.
• Vaccination with a live vaccine within 4 weeks prior to the first administration of IP.
• Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 4 months prior to first IP administration or 5-half-lives, whichever is longer.
• Positive blood screen for active infections including human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) at Screening.
• History of substance abuse or dependency or history of recreational intravenous drug use over the last 12 months (by self-declaration).
• Use of any IP or investigational medical device within 30 days for small molecules (or 5 half-lives of the IP if longer than 30 days) or 90 days for biologics prior to first IP administration.

Where it is running

• Westmead Hospital, Storr Liver Centre, Level 2, A/B Block, Westmead Hospital Corner Hawkesbury and Darcy Roads — Westmead, Westmead, Australia (enrolling)
• TrialsWest Pty Ltd, 90 Anstruther Road — Mandurah, Western Australia (WA), Australia (enrolling)
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
• Genesis Research Services, Ground Floor, 239/245 Denison Street Broadmeadow — Newcastle, New South Wales (nsw), Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
• University of the Sunshine Coast Clinical Trials (Birtinya), UniSC Clinical Trials Vitality Village, Level 4, Tenancy 410, 5 Discovery Court — Birtinya, Queensland (qld), Australia (enrolling)
• Flinders Medical Centre, Flinders Medical Centre, Flinders — Bedford Park, South Australia (SA), Australia (enrolling)
• Box Hill Hospital, Level 1, 5 Arnold street — Box Hill, Victoria, Australia (enrolling)
• St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
• Campbelltown Hospital, Level 10, building A, Campbelltown Hospital, Therry Road, — Campbelltown, New South Wales (nsw), Australia
• Ramsay Health North Shore, North Shore Private, 03 Westbourne Street — Saint Leonards, New South Wales (nsw), Australia

Full record on ClinicalTrials.gov

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