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A Study of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH) or Presumed NASH
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 and B and in participants with a history of NASH or presumed NASH in Part C.
Study details:
The study will consist of 3 parts:. Approximately 96 participants are planned to be enroled into the study. * In Part A (SAD), approximately 48 healthy adult participants are planned to be enroled in 6 cohorts of 8 participants each (Cohorts A1 to A6, 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 NASH or presumed NASH are planned to be enroled in 2 cohorts of 12 participants each (Cohorts C1 to C2).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-09-08
Primary completion: 2024-11-15
Study completion finish: 2024-12-15
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05945537
Intervention or treatment
No interventions found
Conditions
- • Non-alcoholic Steatohepatitis
Find a site
Closest Location:
Royal Prince Alfred Hospital
Research sites nearby
Select from list below to view details:
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Nepean Hospital
Kingswood, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
CMAX Clinical Research
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: A (INI-822)
| Not specified |
PLACEBO_COMPARATOR: B (Placebo)
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of adverse events (AEs). | AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Part A: Up to 5 Weeks |
Incidence of adverse events (AEs). | AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Part A fasted fed crossover cohort: Up to 8 weeks |
Incidence of adverse events (AEs). | AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Part B: Up to 7 weeks |
Incidence of adverse events (AEs). | AEs will be graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Part C: Up to 9 weeks |
Number of participants with clinical laboratory abnormalities | Not Specified | Part A: Up to 5 Weeks |
Number of participants with clinical laboratory abnormalities | Not Specified | Part A fasted fed crossover cohort: Up to 8 weeks |
Number of participants with clinical laboratory abnormalities | Not Specified | Part B: Up to 7 weeks |
Number of participants with clinical laboratory abnormalities | Not Specified | Part C: Up to 9 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Plasma area under the curve (AUC) from time 0 to t (AUC0-t) | Not Specified | 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 |
AUC from time 0 to infinity (AUC0-inf) | Not Specified | 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 |
Maximum concentration (Cmax) | Not Specified | 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 |
Frequently Asked Questions
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