Actively Recruiting
A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH
Led by Inipharm Australia Pty Ltd · Updated on 2025-02-05
104
Participants Needed
7
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Females must not be pregnant or lactating and must use effective contraception from screening until 90 days after last dose, or be abstinent or have same-sex partners.
- Women not of childbearing potential must be postmenopausal for at least 12 months confirmed by hormone testing.
- Males must be surgically sterile or use condoms with partners who are sterile or use contraception during the study.
- Able and willing to attend study visits and provide written informed consent.
- Normal kidney function (eGFR > 60 mL/min).
- For Parts A and B: laboratory values within normal range or approved by investigator, good general health, BMI 18.0 to 30.0 kg/m2, age 18 to 55 years, willing to avoid tobacco and nicotine during study.
- For Part C: age 18 to 65 years.
- For Part C: diagnosis of NASH confirmed by biopsy, fibrosis scoring, clinical diagnosis with metabolic syndrome features, or FibroScan FAST score ≥ 0.35.
- For Part C: ALT > 1.0 x ULN at two times in past 6 months including screening (values <1.0 x ULN considered case-by-case).
- For Part C: FIB-4 score ≤ 2.67, CAP score ≥ 280 Db/m, and liver stiffness measurement ≤ 14 kPa.
- No weight loss >5% in 6 months before screening.
- If on GLP1 agonists, SGLT2 inhibitors, or vitamin E (>400 IU/day), must be on stable dose for at least 3 months.
- Platelet count >150,000 and albumin ≥ 35 g/L.
- BMI 18.0 to 40.0 kg/m2.
You will not qualify if you...
- Any physical or psychological condition that may prevent compliance or completion of the study.
- Blood donation or significant blood loss (>500 mL) within 60 days before dosing.
- Plasma donation within 7 days before dosing.
- Fever (>37.7°C) or symptomatic infection within 2 weeks before Day 1.
- Difficulty swallowing study drug.
- History of severe allergic reaction or sensitivity to study drug or its components.
- Clinically significant abnormalities on physical exam or ECG.
- Unstable vital signs outside defined ranges.
- Other liver diseases including genetic, autoimmune, viral, or alcoholic liver disease.
- Liver cirrhosis or history of decompensated liver disease.
- Major hospitalization or surgery within 6 months before screening.
- Infections requiring intravenous antibiotics within 6 months before screening.
- Live vaccination within 4 weeks before dosing.
- Use of immune suppressing drugs within 4 months before screening.
- Positive blood tests for HIV, hepatitis B, or hepatitis C.
- Recent substance abuse or intravenous drug use.
- Use of investigational drugs or devices within specified timeframes before dosing.
- Bariatric surgery.
- Significant cardiovascular disease or conditions per investigator judgment.
- For Parts A and B: use of prescription or OTC drugs affecting CYP enzymes without approval.
- Clinically significant medical history or drug hypersensitivity.
- History or suspicion of malignancy (exceptions for certain skin cancers).
- Positive drug or alcohol tests at screening.
- History of alcohol use disorder or excessive alcohol consumption.
- For Part C: ALT ≥ 5 x ULN or AST > ALT (except if ALT ≤ ULN).
- For Part C: use of drugs affecting CYP enzymes or CYP2C9 substrates during study.
- For Part C: uncontrolled medical conditions or diabetes (HbA1c > 9.0%).
- For Part C: malignancy within 5 years or significant immunosuppression.
- For Part C: positive drug tests not explained by prescribed meds.
- For Part C: inability to abstain from alcohol as required or consume within limits.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
2
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
4
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
Actively Recruiting
5
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Actively Recruiting
6
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
7
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
K
Katelyn Patterson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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