Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

• Status: Suspended
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atea Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

All:

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

• Must agree to use protocol-specified methods of contraception

• Negative pregnancy test

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

Additional for Part A:

-18-55 years of age

Additional for Part B:

• 18-65 years of age

• HCV genotype 1, 2 or 3

• Documented history compatible with chronic hepatitis C

• HCV RNA ≥ 10,000 IU/mL at Screening

Exclusion Criteria:

All:

• Pregnant or breastfeeding

• Abuse of alcohol or drugs

• Use of other investigational drugs within 30 days of dosing

• Other clinically significant medical conditions

Additional for Part B:

• Prior exposure to any HCV NS5A inhibitor

• Cirrhosis

• Co-infection with hepatitis B virus or HIV