Study of AT-527 in Healthy Subjects (R07496998)

• Sponsor: Atea Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04711187
• Collaborator: Hoffmann-La Roche (Industry)
• Enrollment: 81
• Location: 1
• Arms: 7
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 7.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer Study	Drug: AT-527 Formulation 1; Other: Placebo Comparator; Drug: AT-527 Formulation 2	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase I Study Assessing the Safety and Pharmacokinetics of Multiple Doses of AT-527 in Healthy Subjects
• Actual Study Start Date: Nov 2, 2020
• Actual Primary Completion Date: Sep 15, 2021
• Actual Study Completion Date: Sep 15, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Pharmacokinetics (PK) of AT-527 [Days 1 and 5]

   Maximum plasma concentration (Cmax)

2. Pharmacokinetics (PK) of AT-527 [Days 1 and 5]

   Area under the concentration-time curve (AUC)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atea Study Site	Montréal	Quebec	Canada

Sponsors and Collaborators

• Atea Pharmaceuticals, Inc.
• Hoffmann-La Roche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Atea Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04711187
• Other Study ID Numbers: AT-03A-002
• First Posted: Jan 15, 2021
• Last Update Posted: Feb 25, 2022
• Last Verified: Jul 1, 2021

• 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

Study Results

No Results Posted as of Feb 25, 2022