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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: AT-527 Formulation 1; Other: Placebo Comparator; Drug: AT-527 Formulation 2

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AT-527 Formulation 1 Dose 1	Drug: AT-527 Formulation 1; AT-527 Formulation 1 (R07496998); Other: Placebo Comparator; Placebo Comparator
Experimental: AT-527 Formulation 2 Dose 1	Drug: AT-527 Formulation 2; AT-527 Formulation 2 (R07496998)
Experimental: AT-527 Formulation 2 Dose 2	Other: Placebo Comparator; Placebo Comparator; Drug: AT-527 Formulation 2; AT-527 Formulation 2 (R07496998)
Experimental: AT-527 Formulation 1 Dose 3	Drug: AT-527 Formulation 1; AT-527 Formulation 1 (R07496998); Other: Placebo Comparator; Placebo Comparator
Experimental: AT-527 Formulation 2 Dose 3	Other: Placebo Comparator; Placebo Comparator; Drug: AT-527 Formulation 2; AT-527 Formulation 2 (R07496998)
Experimental: AT-527 Formulation 2 Dose 1 Fast/Fed	Drug: AT-527 Formulation 2; AT-527 Formulation 2 (R07496998)
Experimental: AT-527 Formulation 2 Dose 3 Fast/Fed	Drug: AT-527 Formulation 2; AT-527 Formulation 2 (R07496998)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of AT-527	Maximum plasma concentration (Cmax)	Days 1 and 5
Pharmacokinetics (PK) of AT-527	Area under the concentration-time curve (AUC)	Days 1 and 5

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AT-03A-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes