Study of AT-527 in Combination With Daclatasvir in Subjects With Hepatitis C Virus (HCV) Infection

• Status: Completed
• Trial end date: 2020-03-23
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atea Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Body mass index (BMI) of 18-35 kg/m2

• Must agree to use protocol-specified methods of contraception

• Negative pregnancy test

• HCV genotype 1

• Documented history compatible with chronic hepatitis C

• HCV RNA ≥ 10,000 IU/mL at Screening.

• Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

• Pregnant or breastfeeding

• Infected with hepatitis B virus or HIV

• Abuse of alcohol or drugs

• Prior exposure to any HCV NS5A inhibitor

• Cirrhosis

• Use of other investigational drugs within 30 days of dosing

• Other clinically significant medical conditions or contraindications to daclatasvir