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

Phase 1

Terminated

• Conditions: Dengue
• Interventions: Drug: Placebo Comparator; Drug: AT-752

• Registration Number: NCT05366439
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

This study will assess the safety and antiviral activity of AT-752 in healthy subjects in a Dengue Human Challenge Model

Detailed 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

Study Timeline

• Study Start: 2022-04-22
• Status Verified: 2022-05
• Study First Submitted: 2022-05-05
• Study First Submitted QC: 2022-05-05
• Study First Posted: 2022-05-09
• Primary Completion: 2023-03-16
• Study Completion: 2023-03-16
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparator	Matching placebo administered orally for 14 days
AT-752	AT-752	AT-752 administered orally for 14 days

Primary Outcome Measures

Name	Time	Method
Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC])	Day 2 until 28 days post virus inoculation

Trial Locations

Locations (1)

Atea Study Site; 🇺🇸 Syracuse, New York, United States