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New treatment option for Non-alcoholic Steatohepatitis
Official title A Study of INI-822 in Healthy Volunteers and Participants with Non-alcoholic Steatohepatitis (NASH) or Presumed NASH
ClinicalTrials.gov ID: NCT05945537
What this study is testing
What is INI-822 (A)?
INI-822 (A) is an investigational medicine, being studied as a potential treatment for non-alcoholic steatohepatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception (see Section 7.3.1) from Screening until 90...
- Males must be surgically sterile (\> 30 days since vasectomy [documented evidence] with no viable sperm), or, if engaged in sexual relations with a...
- 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...
- Normal renal function (estimated glomerular filtration rate \> 60 mL/min using Cockcroft-Gault). For Parts A and B only:
You likely can't join 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...
- 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.
See the full eligibility criteria
Who can join
- Females must not be pregnant or lactating, and must use acceptable, highly effective double contraception (see Section 7.3.1) from Screening until 90 days after their last dose of IP or 5 half-lives, whichever is...
- 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...
- 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). For Parts A and B 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...
- 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...
- 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: 11.18 to 65 years of age (inclusive at the time of...
- Historical liver biopsy consistent with NASH (presence of Grade 1 steatosis, hepatocellular ballooning, and lobular inflammation) according to the non-alcoholic fatty liver disease (NAFLD) activity score.
- F0-3 fibrosis according to the NASH Clinical Research Network classification within 1 year of Screening.
- A clinical diagnosis of NASH, 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. 13\. 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...
What rules you out
- 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: Hydroxypropylmethylcellulose Acetate Succinate (HPMCAS), Microcrystalline Cellulose...
- 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...
- 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...
- Systolic blood pressure \ 160 mmHg OR
- Diastolic blood pressure \ 95 mmHg OR
- Pulse rate \ 100 bpm.
- History or presence of other causes of 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 hospitalisation or major surgery within 6 months prior to Screening. Sites are encouraged to confirm with the Sponsor or Medical Monitor if there are any questions on what would be considered major...
- Infections requiring parenteral antibiotics within 6 months prior to Screening.
- 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 Screening 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.
- Anything that the Investigator considers would jeopardise the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.
- Bariatric surgery.
- Cardiovascular disease including heart failure with reduced left ventricular ejection fraction, atrial fibrillation requiring anticoagulation, or any other cardiovascular illness that, in the opinion of the...
- Use of (or anticipated use of) any prescription drugs (other than hormonal contraception; oral contraceptive pills [OCPs], long-acting implantable hormones, injectable hormones, or an intrauterine device [IUD]), any...
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, haematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug...
- History of or suspected malignancy. Participants with basal or squamous cell carcinoma of the skin or carcinoma in situ that has been successfully treated could be included at the discretion of the Investigator or...
- Positive toxicology screening panel (urine test including Methamphetamine, Opiates, Cocaine, tetrahydrocannabinol, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, tricyclic antidepressants and Amphetamine), or...
- History of alcohol use disorder (within 9 months prior to Screening by self-declaration) or habitual consumption of significant amounts of alcohol (by self-declaration), defined as \> 10 standard drinks per week or \> 4...
- ALT ≥ 5 × ULN; AST\>ALT. If ALT ≤ ULN, then AST may be greater than the ALT if it is also ≤ ULN.
- Use of (or anticipated use of) any known drugs or supplements that are moderate or strong inhibitors/inducers of CYP enzymes or any drugs that are substrates of CYP2C9 with a narrow therapeutic index (e.g., warfarin or...
- Participants with uncontrolled medical conditions; the independent MM may be contacted for discussion.
- History of significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack within 6 months prior to the first dose of IP.
- Uncontrolled diabetes mellitus (haemoglobin A1c [HbA1c] \> 9.0% at Screening).
- Malignancy within the last 5 years; basal or squamous cell carcinoma of the skin or carcinoma in situ that has been successfully treated could be included at the discretion of Investigator or designee.
- History or presence of a condition associated with significant immunosuppression.
- Positive toxicology screening panel (urine test including Methamphetamine, Opiates, Cocaine, tetrahydrocannabinol, Phencyclidine, Benzodiazepines, Barbiturates, Methadone, and Amphetamine) at Screening or Day -1. A...
- History of alcohol use disorder (within 9 months prior to Screening by self-declaration) or habitual consumption of significant amounts of alcohol (by self-declaration), defined as \> 10 standard drinks per week or \> 4...
The study team makes the final eligibility decision.
Where it's taking place
- Camperdown, New South Wales, Australia
- Kingswood, New South Wales, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Woodville, South Australia, Australia
- Fitzroy, Victoria, Australia
- Melbourne, Victoria, Australia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camperdown, New South Wales, Australia; Kingswood, New South Wales, Australia; Woolloongabba, Queensland, Australia; Adelaide, South Australia, Australia; Woodville, South Australia, Australia; Fitzroy, Victoria, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.