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

NCT ID: NCT04309734

Last Updated: 2022-06-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2022-09-30

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-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part A - 60 mg AT-777 single dose

Group Type: EXPERIMENTAL

AT-777

Intervention Type: DRUG

Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.

Part A - 120 mg AT-777 single dose

Group Type: EXPERIMENTAL

AT-777

Intervention Type: DRUG

Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.

Part A - Placebo single dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered orally, as one or two placebo capsules, depending on the arm.

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

Group Type: EXPERIMENTAL

AT-777

Intervention Type: DRUG

Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.

AT-527

Intervention Type: DRUG

Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.

Interventions

AT-777

Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.

Intervention Type: DRUG

Placebo

Administered orally, as one or two placebo capsules, depending on the arm.

Intervention Type: DRUG

AT-527

Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao-Jian Zhou

Role: STUDY_DIRECTOR

Atea Pharmaceuticals

Locations

Clinical Trial Site

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2019-004997-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AT-01C-001

Identifier Type: -

Identifier Source: org_study_id