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NCT05366439 Clinical Trial

Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model

Dengue Clinical Trial

Official title:
A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Assess the Antiviral Activity and Safety of AT-752 in a Dengue Human Challenge Model

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05366439
Other study ID # AT-02A-003
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date April 22, 2022
Est. completion date March 16, 2023

Study information
Verified date May 2022
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 and antiviral activity of AT-752 in healthy subjects in a Dengue Human Challenge Model

Description:

A Phase 1, double-blind, randomized, placebo-controlled study to assess the antiviral activity and safety of AT-752 in a Dengue Human Challenge Model

Recruitment information / eligibility
Status Terminated
Enrollment 5
Est. completion date March 16, 2023
Est. primary completion date March 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Must agree to use protocol-specified methods of contraception - Negative pregnancy test - Willing to comply with the study requirements and to provide written informed consent Exclusion Criteria: - Pregnant or breastfeeding - Abuse of drugs - Other clinically significant medical conditions

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AT-752
Parallel Assignment
• Placebo Comparator
Parallel Assignment

Locations
Country Name City State
United States Atea Study Site Syracuse New York

Sponsors (1)
Lead Sponsor Collaborator
Atea Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC]) Day 2 until 28 days post virus inoculation
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