Bronchopulmonary PK of AT-527 (R07496998)

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: AT-527

Study type: Interventional

Funder types: Industry

Identifiers

NCT04877769

AT-03A-007

Details and patient eligibility

About

This study will assess the safety, tolerability and bronchopulmonary pharmacokinetics (PK) of AT-527 (R07496998)

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must agree to use birth control, as required by the protocol.
• Females must have a negative pregnancy test at Screening and prior to dosing
• Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
• Willing to comply with the study requirements and to provide written informed consent

Exclusion criteria

• Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
• Abuse of alcohol or drugs
• Use of other investigational drugs within 28 days of dosing
• Concomitant use of prescription medications, or systemic over-the-counter medications
• Other clinically significant medical conditions or laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

AT-527 Group A

Experimental group

Description:

n=8

Treatment:

Drug: AT-527

AT-527 Group B

Experimental group

Description:

n=8

Treatment:

Drug: AT-527

AT-527 Group C

Experimental group

Description:

n=8

Treatment:

Drug: AT-527