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A Phase 1 Randomised, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH)
Led by Inipharm Australia Pty Ltd · Updated on 2025-02-05
104
Participants Needed
7
Research Sites
4 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating INI-822 in a Phase 1 clinical trial to study its safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers as well as participants with a history or presumed diagnosis of Non-alcoholic Steatohepatitis (NASH). The study includes four parts, involving both single and multiple ascending doses, to better understand how INI-822 behaves in the body and its effects in these populations. The study consists of four parts: Part A enrolls about 48 healthy adults in six cohorts receiving single ascending doses, including a group to assess food effects; Part B includes around 24 healthy adults receiving multiple ascending doses; Part C involves about 24 participants diagnosed with or presumed to have NASH in two cohorts; and Part D enrolls 8 healthy adults receiving single ascending doses. Participants will receive either INI-822 or placebo orally once daily, with the study being randomized and double-blind. Participants will attend scheduled study visits where safety and tolerability will be closely monitored, including checking for adverse events and clinical laboratory abnormalities. Researchers will measure how INI-822 is processed in the body through blood tests over varying periods depending on the study part, ranging from up to 5 to 9 weeks. The trial includes careful monitoring of health status, laboratory results, and pharmacokinetic parameters, with the total duration varying by part to ensure thorough assessment of the drug's effects and safety.
CONDITIONS
Brief 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 highly effective contraception if of childbearing potential
- Males must be surgically sterile or use contraception if sexually active with females of childbearing potential
- Able and willing to attend study visits and provide informed consent
- Normal kidney function (eGFR > 60 mL/min)
- For Parts A and B: normal clinical lab values and good general health with BMI between 18.0 and 30.0 kg/m2, age 18 to 55 years
- For Part C: diagnosed or presumed NASH with specific diagnostic criteria, ALT > 1.00 × ULN at two time points, FIB-4 score ≤ 2.67, BMI between 18.0 and 40.0 kg/m2, age 18 to 65 years
- Stable doses of certain medications if applicable (e.g., GLP1 agonists)
You will not qualify if you...
- Any physical or psychological condition that may interfere with study participation
- Blood donation or significant blood loss within 60 days or plasma donation within 7 days before dosing
- Fever or symptomatic infection within 2 weeks before Day 1
- Difficulty swallowing study medication
- History of severe allergic reactions to study drug or ingredients
- Abnormal physical exam, ECG, or vital signs deemed clinically significant
- Other liver diseases or cirrhosis
- Major hospitalization or surgery within 6 months
- Recent infections requiring antibiotics or live vaccinations
- Exposure to immunosuppressive drugs or investigational drugs/devices recently
- Positive screening for HIV, HBV, or HCV
- Substance abuse history or recent drug use
- Use of certain medications not allowed during Parts A and B
- History of significant cardiovascular, gastrointestinal, or other major diseases
- Positive toxicology or alcohol abuse
- Bariatric surgery
- For Part C: ALT ≥ 5 × ULN, uncontrolled diabetes, malignancy within 5 years, immunosuppression, or other specified exclusions
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks depending on cohort
Participants receive INI-822 or placebo orally once daily in one of several cohorts depending on health status and dosage group.
Multiple visits during dosing up to 9 weeks
Duration - Up to several weeks post-treatment
Participants are monitored for safety and laboratory outcomes after treatment completion.
Visits as scheduled for safety monitoring
Trial Site Locations
Total: 7 locations
1
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
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2
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
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3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
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4
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
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5
The Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
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6
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
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7
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
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Research Team
K
Katelyn Patterson
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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