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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05256732

Enrollment

136

Registered

2022-02-25

Start date

2022-02-22

Completion date

2022-08-23

Last updated

2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer Study

Brief summary

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

Interventions

OTHERPlacebo Comparator fed

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

DRUGAT-527

AT-527 administered twice daily (BID)

DRUGAT-527 fasted

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

OTHERPlacebo Comparator fasted

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

DRUGAT-527 fed

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

DRUGAT-527 single dose

AT-527 single dose fasted/fed cross-over

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK) of AT-527	Day 1	Maximum plasma concentration (Cmax)
Proportions of subjects experiencing treatment-emergent adverse events	Day 1-10	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026