The Study of Bemnifosbuvir in Healthy Japanese Subjects

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Bemnifosbuvir (BEM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05905497

AT-03A-018

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Bemnifosbuvir (BEM)

Experimental group

Description:

oral tablet

Treatment:

Drug: Bemnifosbuvir (BEM)