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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic; Hepatitis C; Chronic Hepatitis C

Treatments: Drug: AT-527; Other: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03219957

AT-01B-001

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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88 participants in 2 patient groups, including a placebo group

AT-527

Experimental group

Treatment:

Drug: AT-527

Placebo

Placebo Comparator group

Treatment:

Other: Placebo Comparator