Study of AT-527 in Healthy Subjects (R07496998)

A Phase I Study Assessing the Safety and Pharmacokinetics of Multiple Doses of AT-527 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04711187

Enrollment

Registered

2021-01-15

Start date

2020-11-02

Completion date

2021-09-15

Last updated

2022-02-25

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 in healthy subjects.

Interventions

DRUGAT-527 Formulation 1

AT-527 Formulation 1 (R07496998)

OTHERPlacebo Comparator

Placebo Comparator

DRUGAT-527 Formulation 2

AT-527 Formulation 2 (R07496998)

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
Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.	Day 10

Secondary

Measure	Time frame	Description
Pharmacokinetics (PK) of AT-527	Days 1 and 5	Maximum plasma concentration (Cmax)

Countries

Canada

Outcome results

None listed

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