Phase I open label study to determine safety, tolerability and pharmacokinetics of single and repeated doses of F351
Phase of Trial: Phase I
Latest Information Update: 10 Oct 2017
At a glance
- Drugs Hydronidone (Primary)
- Indications Hepatic fibrosis
- Focus Adverse reactions; Pharmacokinetics
- 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.