Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal

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

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2022-08-23

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy Volunteer Study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AT-527

Group Type EXPERIMENTAL

AT-527 fasted

Intervention Type DRUG

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

AT-527 fed

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Comparator fasted

Intervention Type OTHER

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

Placebo Comparator fed

Intervention Type OTHER

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

AT-527 BID

Group Type EXPERIMENTAL

AT-527

Intervention Type DRUG

AT-527 administered twice daily (BID)

AT-527 single dose fasted/fed

Group Type EXPERIMENTAL

AT-527 single dose

Intervention Type DRUG

AT-527 single dose fasted/fed cross-over

Interventions

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AT-527 fasted

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

Intervention Type DRUG

Placebo Comparator fasted

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

Intervention Type OTHER

AT-527 fed

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

Intervention Type DRUG

Placebo Comparator fed

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

Intervention Type OTHER

AT-527

AT-527 administered twice daily (BID)

Intervention Type DRUG

AT-527 single dose

AT-527 single dose fasted/fed cross-over

Intervention Type DRUG

Other Intervention Names

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Bemnifosbuvir Bemnifosbuvir Bemnifosbuvir Bemnifosbuvir

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

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes