NCT04971512

A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP-721 in Healthy Subjects (Part 1) and the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of EDP-721 in Combination With EDP-514 in Patients With Chronic Hepatitis B Virus Infection (Part 2)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of EDP-721 in combination with EDP-514 in patients with chronic hepatitis B virus infection.

Conditions

• Chronic Hepatitis B Virus Infection

Interventions

Type	Name	Description
DRUG	EDP-721	Oral administration (Part 1)
DRUG	Placebo (Part 1)	Placebo to match EDP-721, oral administration (Part 1)
DRUG	EDP-721 (Part 2)	Oral administration (Part 2)
DRUG	Placebo (Part 2)	Placebo to match EDP-721 (Part 2)
DRUG	EDP-514	Oral administration
DRUG	Placebo (Part 2)	Placebo to match EDP-514

Timeline

• Start date: 2021-08-02
• Primary completion: 2021-12-20
• Completion: 2021-12-20
• First posted: 2021-07-21
• Last updated: 2022-02-14

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated drug study