Study of AT-527 in Healthy Subjects (R07496998)

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: AT-527 Formulation 1; Drug: AT-527 Formulation 2; Other: Placebo Comparator

• Registration Number: NCT04711187
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-02
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Status Verified: 2021-07
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AT-527 Formulation 2 Dose 2	AT-527 Formulation 2	-
AT-527 Formulation 1 Dose 1	AT-527 Formulation 1	-
AT-527 Formulation 2 Dose 3	AT-527 Formulation 2	-
AT-527 Formulation 2 Dose 3 Fast/Fed	AT-527 Formulation 2	-
AT-527 Formulation 1 Dose 3	AT-527 Formulation 1	-
AT-527 Formulation 2 Dose 1 Fast/Fed	AT-527 Formulation 2	-
AT-527 Formulation 2 Dose 1	AT-527 Formulation 2	-
AT-527 Formulation 1 Dose 3	Placebo Comparator	-
AT-527 Formulation 2 Dose 2	Placebo Comparator	-
AT-527 Formulation 1 Dose 1	Placebo Comparator	-
AT-527 Formulation 2 Dose 3	Placebo Comparator	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of AT-527	Days 1 and 5	Area under the concentration-time curve (AUC)

Trial Locations

Locations (1)

Atea Study Site; 🇨🇦 Montréal, Quebec, Canada