Study of AT-527 in Healthy and HCV-Infected Subjects

• Status: Completed
• Trial end date: 2018-06-20
• Target enrollment: 0
• Participant gender: All

Summary

This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.

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

Details

• Lead Sponsor: Atea Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

All subjects (healthy and HCV-infected subjects):

• Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug

• Must have a negative pregnancy test at Screening and prior to dosing

• Minimum body weight of 50 kg

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

Additional inclusion criteria for HCV-infected subjects:

• Must have not received prior treatment for HCV infection

• Documented clinical history compatible with chronic HCV infection

• Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.

Exclusion Criteria:

All subjects (healthy and HCV-infected subjects):

• Pregnant or breastfeeding

• Infected with hepatitis B virus or HIV

• Abuse of alcohol or drugs

• Use of other investigational drugs within 28 days of dosing

• Other clinically significant medical conditions or laboratory abnormalities