Phase I open label study to determine safety, tolerability and pharmacokinetics of single and repeated doses of F351

Trial Profile

Phase I open label study to determine safety, tolerability and pharmacokinetics of single and repeated doses of F351

Planning
Phase of Trial: Phase I

Latest Information Update: 10 Oct 2017

At a glance

  • Drugs Hydronidone (Primary)
  • Indications Hepatic fibrosis
  • Focus Adverse reactions; Pharmacokinetics
  • Most Recent Events

    • 10 Oct 2017 New trial record
    • 09 Oct 2017 According to GNI media release, GNI USA intends to initiate necessary procedures to start this trial in early 2018. Preliminary results are expected within 2018.
    • 29 Sep 2017 According to GNI media release, GNI USA, Inc. (GNI USA), the wholly-owned subsidiary of GNI Group, had received U.S. FDA clearance on September 29 for the Investigational New Drug application (IND) for F351 (chemical name: Hydronidone) for U.S. clinical trials in the treatment of liver fibrosis.
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