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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer Study
• Intervention / Treatment: Drug: AT-527 fasted; Drug: AT-527 fed; Other: Placebo Comparator fasted; Other: Placebo Comparator fed; Drug: AT-527; Drug: AT-527 single dose

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Montreal, Quebec
    • Québec, Montreal, Quebec, Canada
      • Atea Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo Comparator fasted; Matching placebo administered twice daily (BID) for 5 days fasted; Other: Placebo Comparator fed; Matching placebo administered twice daily (BID) for 5 days fed
Experimental: AT-527	Drug: AT-527 fasted; AT-527 administered twice daily (BID) for 5 days fasted; Other Names: Bemnifosbuvir; Drug: AT-527 fed; AT-527 administered twice daily (BID) for 5 days fed; Other Names: Bemnifosbuvir
Experimental: AT-527 BID	Drug: AT-527; AT-527 administered twice daily (BID); Other Names: Bemnifosbuvir
Experimental: AT-527 single dose fasted/fed	Drug: AT-527 single dose; AT-527 single dose fasted/fed cross-over; Other Names: Bemnifosbuvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) of AT-527	Maximum plasma concentration (Cmax)	Day 1
Pharmacokinetics (PK) of AT-527	Area under the concentration-time curve (AUC)	Day 1
Pharmacokinetics (PK) of AT-527	Trough plasma concentration (Ctrough)	Day 1
Proportions of subjects experiencing treatment-emergent adverse events		Day 1-10

Collaborators and Investigators

• Sponsor: Atea Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AT-03A-015

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