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Bronchopulmonary PK of AT-527 (R07496998)

Sponsor
Atea Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04877769
Collaborator
Hoffmann-La Roche (Industry)
24
Enrollment
1
Location
3
Arms
4.2
Actual Duration (Months)
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Apr 25, 2021
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: AT-527 Group A

n=8

Drug: AT-527
administered twice daily (BID) for 2.5 days (5 doses in total)
Other Names:
  • RO7496998

    		•
    Experimental: AT-527 Group B

    n=8

    Drug: AT-527
    administered twice daily (BID) for 2.5 days (5 doses in total)
    Other Names:
  • RO7496998

    		•
    Experimental: AT-527 Group C

    n=8

    Drug: AT-527
    administered twice daily (BID) for 2.5 days (5 doses in total)
    Other Names:
  • RO7496998

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Concentrations of AT-527 in epithelial lining fluid [4-5 hours after last dose and 11-12 hours after last dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Atea Study Site London United Kingdom NW10 7EW

    Sponsors and Collaborators

    • Atea Pharmaceuticals, Inc.
    • Hoffmann-La Roche

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Atea Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04877769
    Other Study ID Numbers:
    • AT-03A-007
    First Posted:
    May 7, 2021
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes

    Study Results

    No Results Posted as of Feb 25, 2022