Clinical trial

Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects

Name

AT-03A-015

Description

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects

Trial arms

Trial start

2022-02-22

Estimated PCD

2022-08-23

Trial end

2022-08-23

Status

Completed

Phase

Early phase I

Treatment

AT-527 fasted

AT-527 administered twice daily (BID) for 5 days fasted

Arms:

AT-527

Other names:

Bemnifosbuvir

Placebo Comparator fasted

Matching placebo administered twice daily (BID) for 5 days fasted

Arms:

Placebo

AT-527 fed

AT-527 administered twice daily (BID) for 5 days fed

Arms:

AT-527

Other names:

Bemnifosbuvir

Placebo Comparator fed

Matching placebo administered twice daily (BID) for 5 days fed

Arms:

Placebo

AT-527

AT-527 administered twice daily (BID)

Arms:

AT-527 BID

Other names:

Bemnifosbuvir

AT-527 single dose

AT-527 single dose fasted/fed cross-over

Arms:

AT-527 single dose fasted/fed

Other names:

Bemnifosbuvir

Size

136

Primary endpoint

Pharmacokinetics (PK) of AT-527

Day 1

Pharmacokinetics (PK) of AT-527

Day 1

Pharmacokinetics (PK) of AT-527

Day 1

Proportions of subjects experiencing treatment-emergent adverse events

Day 1-10

Eligibility criteria

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 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 136, 'type': 'ACTUAL'}}

Updated at

2022-10-18

1 organization

1 product

1 indication

Product

AT-527

Indication

Healthy Volunteer Study

Organization

Atea Pharmaceuticals