Study of AT-527 in Healthy Subjects (R07496998)

Healthy Volunteer Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711187
• Other study ID #: AT-03A-002
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: July 2021
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• AT-527 Formulation 1
AT-527 Formulation 1 (R07496998)

Other:
• Placebo Comparator
Placebo Comparator

Drug:
• AT-527 Formulation 2
AT-527 Formulation 2 (R07496998)

Locations

Country	Name	City	State
Canada	Atea Study Site	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events.		Day 10
Secondary	Pharmacokinetics (PK) of AT-527	Maximum plasma concentration (Cmax)	Days 1 and 5
Secondary	Pharmacokinetics (PK) of AT-527	Area under the concentration-time curve (AUC)	Days 1 and 5