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

Atea Pharmaceuticals, Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

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

Interventions

AT-777DRUG

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

PlaceboDRUG

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

AT-527DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinical Trial Site

Antwerp, Belgium

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Number of subjects experiencing treatment-emergent adverse events

Time frame: Through Day 6 for subjects in Part A

Incidence of Treatment-Emergent Adverse Events

Number of subjects experiencing treatment-emergent adverse events

Time frame: Through 4 weeks after end of treatment for subjects in Part B

Antiviral Activity of AT-777 and AT-527

Number of subjects who achieve plasma HCV RNA \< lower limit of quantitation (LLOQ) and target not detected (TND)

Time frame: Through 2 weeks of treatment for subjects in Part B

Secondary Outcomes

AT-777 maximum plasma concentration (Cmax)

Time frame: Day 1 for subjects in Part A

AT-777 area under the concentration-time curve (AUC)

Time frame: Day 1 for subjects in Part A

Proportion of subjects achieving sustained virologic response (SVR)

SVR defined as the HCV RNA \< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment

Time frame: 12 weeks after end of treatment for subjects in Part B

Data from ClinicalTrials.gov

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