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

Atea Pharmaceuticals

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Hepatitis C, Chronic; Hepatitis C; HCV Infection; Hepatitis C Virus Infection; Chronic Hepatitis C

Treatments: Drug: AT-777; Drug: Placebo; Drug: AT-527

Study type: Interventional

Funder types: Industry

Identifiers

NCT04309734

AT-01C-001

2019-004997-24 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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0 participants in 4 patient groups, including a placebo group

Part A - 60 mg AT-777 single dose

Experimental group

Treatment:

Drug: AT-777

Part A - 120 mg AT-777 single dose

Experimental group

Treatment:

Drug: AT-777

Part A - Placebo single dose

Placebo Comparator group

Treatment:

Drug: Placebo

Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks

Experimental group

Treatment:

Drug: AT-527

Drug: AT-777