Bronchopulmonary PK of AT-527 (R07496998)

NCT ID: NCT04877769

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-25

Study Completion Date

2021-08-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AT-527 Group A

n=8

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

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

AT-527 Group B

n=8

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

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

AT-527 Group C

n=8

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

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

Interventions

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AT-527

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

Intervention Type DRUG

Other Intervention Names

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RO7496998

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AT-03A-007

Identifier Type: -

Identifier Source: org_study_id

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