A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-305 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-305 Pharmacokinetics in Healthy Subjects, and of Multiple Ascending Doses (MAD) in Subjects With Presumptive NAFLD
Phase of Trial: Phase I
Latest Information Update: 23 Aug 2017
At a glance
- Drugs EDP 305 (Primary)
- Indications Non-alcoholic fatty liver disease
- Focus Adverse reactions; First in man
- Sponsors Enanta Pharmaceuticals
- 16 Aug 2017 Status changed from recruiting to completed.
- 16 May 2017 Planned number of patients changed from 150 to 146.
- 19 Apr 2017 According to an Enanta Pharmaceuticals media release, the study will enroll approximately 150 subjects and is planned to evaluate at least 5 single and multiple dose cohorts.