Status:
WITHDRAWN
Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Lead Sponsor:
Atea Pharmaceuticals, Inc.
Conditions:
Hepatitis C
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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-7...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04309734
Start Date
October 1 2021
End Date
September 1 2022
Last Update
June 8 2022
Active Locations (1)
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1
Clinical Trial Site
Antwerp, Belgium