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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 07 Feb 2025

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At a glance

  • Drugs INI 822 (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Adverse reactions
  • Sponsors Inipharm

    • Most Recent Events

    • 05 Feb 2025 Planned number of patients changed from 96 to 104.
    • 05 Feb 2025 Planned End Date changed from 15 Dec 2024 to 15 Jun 2025.
    • 05 Feb 2025 Planned primary completion date changed from 15 Nov 2024 to 15 May 2025.

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