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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05366439
Recruitment Status : Terminated (Sponsor decision to deprioritize the dengue program)
First Posted : May 9, 2022
Last Update Posted : April 21, 2023
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Dengue Drug: AT-752 Drug: Placebo Comparator Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 22, 2022
Actual Primary Completion Date : March 16, 2023
Actual Study Completion Date : March 16, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05366439


Locations
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United States, New York
Atea Study Site
Syracuse, New York, United States, 13215
Sponsors and Collaborators
Atea Pharmaceuticals, Inc.
More Information
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Responsible Party: Atea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05366439    
Other Study ID Numbers: AT-02A-003
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: April 21, 2023
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dengue
Arbovirus Infections
Vector Borne Diseases
Infections
Virus Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral