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

April 20, 2023 updated by: Atea Pharmaceuticals, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13215
        • Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AT-752
AT-752 administered orally for 14 days
Drug: AT-752
Parallel Assignment
Placebo Comparator: Placebo
Matching placebo administered orally for 14 days
Drug: Placebo Comparator
Parallel Assignment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Actual)

March 16, 2023

Study Completion (Actual)

March 16, 2023

Study Registration Dates

First Submitted

May 5, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-02A-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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