Phase 1 Study to Evaluate Safety and Dosing of INI-822 in Healthy Adults and Adults with Metabolic Dysfunction-Associated Steatohepatitis MASH

What this Trial Is About

Researchers are conducting a Phase 1 trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug INI-822 in healthy volunteers and participants with Metabolic Dysfunction-Associated Steatohepatitis MASH or presumed MASH. The study includes multiple parts involving different groups, including healthy adults and those diagnosed with MASH, to understand the drugs effects and behavior in the body. The trial consists of six parts, enrolling approximately 168 participants divided into cohorts. Participants will receive oral doses of INI-822 or matching placebo once daily. The study includes single ascending dose SAD and multiple ascending dose MAD phases, crossover assessments for food effects, and pharmacodynamic evaluations in participants with MASH or presumed MASH. Study durations for participants vary from 5 to 18 weeks depending on the part. Participants will attend screening visits and receive study drug or placebo as assigned. Researchers will monitor safety through adverse event tracking and laboratory tests, assess drug levels in the blood, and evaluate pharmacodynamic responses. The study is randomized and double-blinded, with close monitoring throughout each part. Total participation time depends on the cohort but may last up to 18 weeks including screening.

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