Skip to main content
OpenTrials
Completed

NCT Number: NCT04711187

Study of AT-527 in Healthy Subjects (R07496998)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer Study

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Montreal, Quebec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT-527 Formulation 1

Drug

AT-527 Formulation 1 (R07496998)

Placebo Comparator

Other

Placebo Comparator

AT-527 Formulation 2

Drug

AT-527 Formulation 2 (R07496998)

Primary outcomes

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

    Time frame: Day 10

Secondary outcomes

  1. Pharmacokinetics (PK) of AT-527

    Time frame: Days 1 and 5

    Maximum plasma concentration (Cmax)

  2. Pharmacokinetics (PK) of AT-527

    Time frame: Days 1 and 5

    Area under the concentration-time curve (AUC)

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

A Phase I Study Assessing the Safety and Pharmacokinetics of Multiple Doses of AT-527 in Healthy Subjects

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2021
Registry last updated
Feb 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.