Bronchopulmonary PK of AT-527 (R07496998)

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: AT-527

• Registration Number: NCT04877769
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04-25
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-07
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AT-527 Group C	AT-527	n=8
AT-527 Group A	AT-527	n=8
AT-527 Group B	AT-527	n=8

Primary Outcome Measures

Name	Time	Method
Concentrations of AT-527 in epithelial lining fluid	4-5 hours after last dose and 11-12 hours after last dose

Trial Locations

Locations (1)

Atea Study Site; 🇬🇧 London, United Kingdom