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Metabolic Dysfunction-Associated SteatohepatitisPhase 1NCT05945537

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

A Phase 1 study testing INI-822 (A) in people with Metabolic Dysfunction-Associated Steatohepatitis, run by Inipharm Australia Pty Ltd at 12 sites in Australia.

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Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
INI-822 (A)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
168 participants
Where
12 sitesAustralia
Study dates
8 Sep 2023to 30 Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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:
  • 11.18 to 65 years of age (inclusive at the time of informed consent).
  • 12. 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.
  • 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 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.
  • 14. 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.
  • 15. No documented weight loss > 5% in the 6 months preceding Screening.
  • 16. 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.
  • 17. Platelet count > 150,000 and albumin ≥ 35 g/L.
  • 18. BMI Greater than equals to 18.0 and ≤ 40.0 kg/m2
  • For Part E only:
  • 19. 18 to 70 years of age (inclusive at the time of informed consent).
  • 20. A diagnosis of MASH confirmed by 1 or more of the following:
  • Historical liver biopsy within 1 year of Screening, 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.
  • FibroScan-aspartate aminotransferase (FAST) score ≥ 0.36 and AST ≥ 24.
  • 21. FIB-4 score ≤ 3.25, CAP score by FibroScan® ≥ 280 Db/m, and LSM by FibroScan® ≤ 15 kPa.
  • 22. No documented weight loss > 5% in the 6 months prior to first IP administration.
  • 23. If on GLP1 agonists, SGLT2 inhibitors, or vitamin E (dose ≥ 400 IU/day), then should have been on a stable dose for at least 3 months prior to first IP administration.
  • 24. Platelet count ≥ 150,000 and albumin ≥ 35 g/L at Screening and Day -1 Visits.
  • 25. BMI ≥ 18.0 and ≤ 45.0 kg/m2.

Who cannot join

  • 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.
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  • 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.
  • 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 Investigator, warrants exclusion from the study.
  • For Parts A and B , D, and F only:
  • 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 known drugs or supplements that are moderate or strong inhibitors/inducers of cytochrome P450 (CYP) enzymes, over-the-counter (OTC) medication, herbal remedies, supplements or vitamins within 48 hours of IP administration and during the course of the study without prior approval of the Investigator and independent MM. Simple analgesia (paracetamol < 2 g/day) may be permitted at the discretion of the Investigator.
  • Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, haematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity, as determined by the Investigator.
  • 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 designee.
  • Positive toxicology screening panel (urine test including methamphetamine, opiates, cocaine, tetrahydrocannabinol, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants and amphetamine), or alcohol breath test at Screening, Day -1, or Day 7 (Part D).
  • 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 standard drinks on any single day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine). Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 visits and until study completion are to be excluded.
  • For Part C only:
  • 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 other coumarin based anticoagulants, phenytoin, celecoxib, glimepiride, tolbutamide or phenobarbital or other drugs metabolised by CYP2C9) or any oral drugs that are significantly metabolised by CYP3A4 (e.g., alfentanil, apixaban, avanafil, buspirone, cyclosporine, dihydroergotamine, ergotamine, fentanyl, oxybutinin, losartan, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, pimozide, quinidine, sildenafil, simvastatin, sirolimus, tadalafil, tamsulosin, tacrolimus and zopiclone), during the course of the study. Prescription medications for stable medical condition may be allowable if the Investigator considers they will not interfere with the study; the independent MM may be contacted to discuss any particular medications.
  • 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, tricyclic antidepressants, and Amphetamine) at Screening or Day -1. A positive toxicology screening that is explained by a prescribed medication is allowable.
  • 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 standard drinks in a day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine). Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 visits are to be excluded. Participants unable to consume 10 standard drinks or fewer in a week or 2 standard drinks in a day or fewer during the study are to be excluded.
  • For Part E only:
  • ALT ≥ 5 × ULN; AST>ALT at Screening and Day -1 Visits.
  • 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 other coumarin-based anticoagulants, phenytoin, celecoxib, glimepiride, tolbutamide or phenobarbital or other drugs metabolized by CYP2C9) or any oral drugs that are significantly metabolised by CYP3A4 (e.g., alfentanil, apixaban, avanafil, buspirone, cyclosporine, dihydroergotamine, ergotamine, fentanyl, oxybutynin, losartan, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, pimozide, quinidine, sildenafil, simvastatin, sirolimus, tadalafil, tamsulosin, tacrolimus, and zopiclone), during the course of the study. Prescription medications for stable medical condition may be allowable if the Investigator considers they will not interfere with the study; the independent MM may be contacted to discuss any particular medications.
  • 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% [76 mmol/mol] at Screening).
  • Malignancy within the last 5 years prior to IP administration; 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. Sites are encouraged to confirm with the Sponsor or MM if there are any questions on what would be considered significant immunosuppression.
  • Positive toxicology screening panel (urine test including methamphetamine, opiates, cocaine, tetrahydrocannabinol, phencyclidine, benzodiazepines, barbiturates, methadone, tricyclic antidepressants, and amphetamine), at Screening or Day -1. A positive toxicology screening that is explained by a prescribed medication is allowable.
  • 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 standard drinks in a day (where 1 standard drink = 360 mL of beer, 45 mL of 40% spirit, or a 150 mL glass of wine) or presence of circulating phosphatidyl ethanol (PEth) levels >35 ng/mL at Screening. Participants who are unable to abstain from alcohol 72 hours prior to Screening and Day -1 Visits are to be excluded. Participants unable to consume 10 standard drinks or fewer in a week or 2 standard drinks in a day or fewer during the study are to be excluded.
  • Note: Sites may determine full eligibility and randomize after Day -1 assessments and eligibility review. Any assessments completed prior to dosing on Day 1 should be reviewed by an Investigator prior to the first dose.

Trial locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Katelyn Patterson contact

+1 209-402-1568

kpatterson@inipharm.com

12 sites in 1 country

Australia12 sites, 12 recruiting

  • Flinders Medical Centre, Flinders Medical Centre, Flinders

    Bedford Park, South Australia (SA), 5042

    Libby Cagney, +64 8 82047544, Libby.cagney@sa.gov.au

    Dr Kate Muller

    Recruiting

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

    Birtinya, Queensland (qld), 4575

    Lindley Mattiazzi, +61 7 5456 5133, lmattiazzi@usc.edu.au

    Dr. James O'Beirne

    Recruiting

  • Box Hill Hospital, Level 1, 5 Arnold street

    Box Hill, Victoria, 3128

    Emma Dimitri, +61 3 9094 9548, emma.dimitri@monash.edu

    Dr. Alexander Hodge

    Recruiting

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

    Campbelltown, New South Wales (nsw), 2560

    Shaynne Ram, +61 473 855 642, Shaynne.Ram@health.nsw.gov.au

    Vincent Ho

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Georgia Martin, +61 2 9515 6006, georgia.martin@health.nsw.gov.au

    Simone Strasser

    Recruiting

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    Jacinta McMahon, +61 3 9231 3518, jacinta.mcmahon@svha.org.au

    Alexander Thompson

    Recruiting

  • TrialsWest Pty Ltd, 90 Anstruther Road

    Mandurah, Western Australia (WA), 6210

    Helen Pavitt, +61 (0) 406 681 800, Helen.pavitt@trialswest.com.au

    Prof John Olynyk

    Recruiting

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

    Newcastle, New South Wales (nsw), 2292

    Melissa Young, +61 2 4985 1860, melissa@genesisresearchservices.com

    Dr. Lay Gan

    Recruiting

  • TrialsWest Pty Ltd, 226 Main Street

    Osborne Park, Western Australia (WA), 6017

    Helen Pavitt, +61 (0) 406 681 800, Helen.pavitt@trialswest.com.au

    Prof John Olynyk

    Recruiting

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

    Saint Leonards, New South Wales (nsw), 2065

    Karen Ji, +61 2 8425 3022, JiK@ramsayhealth.com.au

    Dr. Cameron Gofton

    Recruiting

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

    Westmead, Westmead, 2145

    Tahiyea Khan, +61 2 8890 8904, Tahiyea.khan@health.nsw.gov.au

    Professor Jacob George

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Grace Porter, +61 7 3443 7824, grace.porter@tri.edu.au

    James Thomas

    Recruiting

Other trials in Australia

About this study

Official title: 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)

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.

Read the detailed description

The study will consist of 6 parts:

Approximately 168 participants are planned to be enroled into the study.

  • In Part A (SAD), approximately 48 healthy adult participants are planned to be enroled in 5 cohorts of 8 participants each (Cohorts A1 to A5, including one fasted:fed crossover cohort to assess food effect).
  • In Part B (MAD), approximately 24 healthy adult participants are planned to be enroled in 3 cohorts of 8 participants each (Cohorts B1 to B3).
  • In Part C (Pharmacodynamics), approximately 24 participants with Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH) are planned to be enrolled in 2 cohorts of 12 participants each (Cohorts C1 to C2).
  • In Part D (SAD Tablet Formulation Crossover), approximately 8 healthy adult participants are planned to be enrolled in 1 Cohort of 8 participants.
  • In Part E (POC), approximately 48 participants with Metabolic Dysfunction-Associated Steatohepatitis (MASH) are planned to be enrolled in 2 cohorts of approximately 24 participants each (Cohorts E1 to E2).
  • In Part F (TMD), approximately 24 healthy adult participants are planned to be enrolled in 3 cohorts of 8 participants each (Cohorts F1 to F3).

Note: The total number of participants planned is 168 as Cohort A6 has been removed based on SRC review.

Estimated overall study duration: 18 months

Estimated study duration for each participant:

  • Part A: up to 5 weeks including Screening for 5 fasted cohorts and at least 7 weeks for the fasted:fed crossover cohort, dependent on Safety Review Committee (SRC) decision on timing of the fed dosing (healthy volunteers)
  • Part B: up to 7 weeks including Screening (healthy volunteers)
  • Part C: up to 9 weeks including Screening (participants with MASH or presumed MASH)
  • Part D: up to 6 weeks including Screening (healthy volunteers)
  • Part E: up to 18 weeks including Screening (participants with MASH)
  • Part F: up to 7 weeks including Screening (healthy volunteers)
Being tested
INI-822 (A), Placebo (B)
Keywords
Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INI-822 (A)Drug

    Different dose levels of INI-822

  • Placebo (B)Other

    Matching placebo to INI-822

Study groups in NCT05945537
Study groupRoleWhat they receive
A (INI-822)ExperimentalParticipants will receive INI-822 orally once daily.
Receives: Drug: INI-822 (A)
B (Placebo)Placebo comparatorParticipants will receive placebo orally once daily.
Receives: Other: Placebo (B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs).

    AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Part A: Up to 5 Weeks

  2. Incidence of adverse events (AEs).

    AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Part A fasted fed crossover cohort: Up to 8 weeks

  3. Incidence of adverse events (AEs).

    AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Part B: Up to 7 weeks

  4. Incidence of adverse events (AEs).

    AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Part C: Up to 9 weeks

  5. Number of participants with clinical laboratory abnormalities

    Abnormal laboratory findings (e.g., haematology, biochemistry, coagulation, and urinalysis) or other abnormal assessments (e.g., ECG and vital signs) per se are not reported as AEs.

    Measured: Part A: Up to 5 Weeks

  6. Number of participants with clinical laboratory abnormalities

    Abnormal laboratory findings (e.g., haematology, biochemistry, coagulation, and urinalysis) or other abnormal assessments (e.g., ECG and vital signs) per se are not reported as AEs.

    Measured: Part A fasted fed crossover cohort: Up to 8 weeks

  7. Number of participants with clinical laboratory abnormalities

    Abnormal laboratory findings (e.g., haematology, biochemistry, coagulation, and urinalysis) or other abnormal assessments (e.g., ECG and vital signs) per se are not reported as AEs.

    Measured: Part B: Up to 7 weeks

  8. Number of participants with clinical laboratory abnormalities

    Abnormal laboratory findings (e.g., haematology, biochemistry, coagulation, and urinalysis) or other abnormal assessments (e.g., ECG and vital signs) per se are not reported as AEs.

    Measured: Part C: Up to 9 weeks

  9. Incidence of adverse events (AEs)

    AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Part E: Up to 12 weeks

  10. Incidence of adverse events (AEs)

    AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: Part F: Up to 2 weeks

  11. Number of participants with clinical laboratory abnormalities

    Abnormal laboratory findings (e.g., haematology, biochemistry, coagulation, and urinalysis) or other abnormal assessments (e.g., ECG and vital signs) per se are not reported as AEs.

    Measured: Part E: Up to 12Weeks

  12. Number of participants with clinical laboratory abnormalities

    Abnormal laboratory findings (e.g., haematology, biochemistry, coagulation, and urinalysis) or other abnormal assessments (e.g., ECG and vital signs) per se are not reported as AEs.

    Measured: Part F: Up to 2Weeks

Secondary outcomes (6)

  1. Plasma area under the curve (AUC) from time 0 to t (AUC0-t)

    The results of the outcome are collectively measured.

    Measured: Part A: Up to 5 Weeks, Part A fasted fed crossover cohort: Up to 8 weeks, Part B: Up to 7 weeks, Part C: Up to 9 weeks, Part E: Up to 12 Week

  2. AUC from time 0 to infinity (AUC0-inf)

    The results of the outcome are collectively measured.

    Measured: Part A: Up to 5 Weeks, Part A fasted fed crossover cohort: Up to 8 weeks, Part B: Up to 7 weeks, Part C: Up to 9 weeks

  3. Maximum concentration (Cmax)

    The results of the outcome are collectively measured.

    Measured: Part A: Up to 5 Weeks, Part A fasted fed crossover cohort: Up to 8 weeks, Part B: Up to 7 weeks, Part C: Up to 9 weeks

  4. Plasma area under the curve (AUC) from time 0 to t (AUC0-t)

    The results of the outcome are collectively measured.

    Measured: Part E: Up to 12 Week, Part F: Week 2

  5. AUC from time 0 to infinity (AUC0-inf)

    The results of the outcome are collectively measured.

    Measured: Part E: Up to 12 Week, Part F: Week 2

  6. Maximum concentration (Cmax)

    The results of the outcome are collectively measured.

    Measured: Part E: Up to 12 Week, Part F: Week 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start8 Sep 2023
  3. Primary completion31 May 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
168 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05945537
Sponsor's protocol ID
INI-822-001
Status last verified
Nov 2026
First submitted
27 Jun 2023
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INI-822 (A) in people with Metabolic Dysfunction-Associated Steatohepatitis, run by Inipharm Australia Pty Ltd at 12 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Katelyn Patterson (+1 209-402-1568, kpatterson@inipharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs). (time frame: Part A: Up to 5 Weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05945537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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