Back to resultsStudy of AT-752 in Healthy Subjects in a Dengue Human Challenge Model
Primary Purpose
Dengue
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AT-752
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Dengue
Eligibility 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
Sites / Locations
- Atea Study Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AT-752
Placebo
Arm Description
AT-752 administered orally for 14 days
Matching placebo administered orally for 14 days
Outcomes
Primary Outcome Measures
Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC])
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05366439
Brief Title
Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to deprioritize the dengue program
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
March 16, 2023 (Actual)
Study Completion Date
March 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atea Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AT-752
Arm Type
Experimental
Arm Description
AT-752 administered orally for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo administered orally for 14 days
Intervention Type
Drug
Intervention Name(s)
AT-752
Intervention Description
Parallel Assignment
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Parallel Assignment
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Atea Study Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model
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