A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated S… (NCT05945537) | Clinical Trial Compass
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Australia168 participantsStarted 2023-09-08
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs).
Timeframe: Part A: Up to 5 Weeks
2
Incidence of adverse events (AEs).
Timeframe: Part A fasted fed crossover cohort: Up to 8 weeks
3
Incidence of adverse events (AEs).
Timeframe: Part B: Up to 7 weeks
4
Incidence of adverse events (AEs).
Timeframe: Part C: Up to 9 weeks
5
Number of participants with clinical laboratory abnormalities
Timeframe: Part A: Up to 5 Weeks
6
Number of participants with clinical laboratory abnormalities
Timeframe: Part A fasted fed crossover cohort: Up to 8 weeks
7
Number of participants with clinical laboratory abnormalities
. 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.
. 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.
Exclusion criteria
. 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).
Number of participants with clinical laboratory abnormalities
Timeframe: Part C: Up to 9 weeks
9
Incidence of adverse events (AEs)
Timeframe: Part E: Up to 12 weeks
10
Incidence of adverse events (AEs)
Timeframe: Part F: Up to 2 weeks
11
Number of participants with clinical laboratory abnormalities
Timeframe: Part E: Up to 12Weeks
12
Number of participants with clinical laboratory abnormalities