The Study of Bemnifosbuvir in Healthy Japanese Subjects

NCT ID: NCT05905497

Last Updated: 2023-06-15

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

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-26

Study Completion Date

2023-05-19

Brief Summary

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This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects

Detailed Description

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Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bemnifosbuvir (BEM)

oral tablet

Group Type EXPERIMENTAL

Bemnifosbuvir (BEM)

Intervention Type DRUG

BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)

Interventions

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Bemnifosbuvir (BEM)

BEM administered BID for 4 days and QD on Day 5 (9 consecutive doses)

Intervention Type DRUG

Other Intervention Names

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AT-527

Eligibility Criteria

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Inclusion Criteria

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* 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 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent
* The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent
* The subject must have lived outside of Japan for no more than 10 years

Exclusion Criteria

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Cypress, California, United States

Site Status

Countries

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United States

Other Identifiers

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AT-03A-018

Identifier Type: -

Identifier Source: org_study_id

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