Clinical Trials Logo
  1. Home
  2. Non-Alcoholic Steatohepatitis
  3. NCT05945537

A Study of INI-822 in Healthy Volunteers and Participants With Non-alcoholic Steatohepatitis (NASH) or Presumed NASH

Non-alcoholic Steatohepatitis Clinical Trial

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 Non-alcoholic Steatohepatitis (NASH) or Presumed NASH

Clinical 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 and B and in participants with a history of NASH or presumed NASH in Part C.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05945537
Study type Interventional
Source Inipharm Australia Pty Ltd
Contact Katelyn Patterson
Phone +1 209-402-1568
Email kpatterson@inipharm.com
Status Recruiting
Phase Phase 1
Start date September 8, 2023
Completion date July 28, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Recruiting NCT05065593 - The Effect of Aerobic and Resistant Exercise Training in Patients With Non-Alcoholic Steatohepatitis N/A
Terminated NCT04171765 - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis Phase 2
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Active, not recruiting NCT02912260 - Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT06054815 - Study to Evaluate the Efficacy and Safety of DA-1241 in Subjects With Presumed NASH Phase 2
Completed NCT02784444 - A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH Phase 2
Not yet recruiting NCT06160271 - Study of Liver Fibrosis Stage Assessment by Fibroblast Activation Protein Imaging in Patients With Biopsy for Suspected or Proven Nonalcoholic Steatohepatitis Phase 2
Active, not recruiting NCT05573204 - Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients With Non-alcoholic Steatohepatitis Phase 2
Completed NCT04042142 - Glucagon Resistance in Patients With NAFLD N/A
Completed NCT04657523 - Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study N/A
Completed NCT04142424 - A Study to Understand the Safety, Tolerability, and Activity of Drug in Body Over a Period of Time of AZD2693, in Subjects of Non-Childbearing Potential in Overweight But Otherwise Healthy Subjects, and Healthy Chinese and Japanese Subjects Phase 1
Terminated NCT02787304 - Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) Phase 2
Recruiting NCT04666402 - Integrated Diagnostics for Early Diagnosis of Liver Disease
Completed NCT02528305 - The Effect of HIT in Patients With Non-alcoholic Fatty Liver Disease/Steatohepatitis N/A
Recruiting NCT01056133 - Effect of Fish-oil on Non-alcoholic Steatohepatitis (NASH) Phase 2
Completed NCT04806750 - Emricasan, an Oral Caspase Inhibitor, in Subjects With Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension Phase 2
Completed NCT02960204 - Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension Phase 2
Recruiting NCT05751720 - Effect on Non-Alcoholic Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus With Gastric Inhibitory Polypeptide/Glucagon Like Peptide-1 Analogue Phase 1/Phase 2
Completed NCT02571192 - A Study to Investigate How the Study Drug SHP626 is Eliminated From the Body After One Dose Phase 1