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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04711187
Other study ID # AT-03A-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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