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Bronchopulmonary PK of AT-527 (R07496998)

A Phase 1, Open-label, Randomized Study in Healthy Subjects to Assess the Bronchopulmonary Pharmacokinetics, Safety and Tolerability of AT-527, a Potential Treatment for COVID-19

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04877769
Enrollment
24
Registered
2021-05-07
Start date
2021-04-25
Completion date
2021-08-31
Last updated
2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer Study

Brief summary

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

Interventions

DRUGAT-527

administered twice daily (BID) for 2.5 days (5 doses in total)

Sponsors

Hoffmann-La Roche
CollaboratorINDUSTRY
Atea Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Concentrations of AT-527 in epithelial lining fluid4-5 hours after last dose and 11-12 hours after last dose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026