NCT05256732

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	AT-527 fasted	AT-527 administered twice daily (BID) for 5 days fasted
OTHER	Placebo Comparator fasted	Matching placebo administered twice daily (BID) for 5 days fasted
DRUG	AT-527 fed	AT-527 administered twice daily (BID) for 5 days fed
OTHER	Placebo Comparator fed	Matching placebo administered twice daily (BID) for 5 days fed
DRUG	AT-527	AT-527 administered twice daily (BID)
DRUG	AT-527 single dose	AT-527 single dose fasted/fed cross-over

Timeline

• Start date: 2022-02-22
• Primary completion: 2022-08-23
• Completion: 2022-08-23
• First posted: 2022-02-25
• Last updated: 2022-10-18

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study