Study of AT-752 in Healthy Subjects in a Dengue Human Challenge Model
Sponsor
Atea Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05366439
Collaborator
(none)
12
1
2
6
2
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Type:
Interventional
Anticipated Enrollment
:
12 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
Anticipated Study Start Date
:
May 1, 2022
Anticipated Primary Completion Date
:
Nov 1, 2022
Anticipated Study Completion Date
:
Nov 1, 2022
Arms and Interventions
| 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
Primary Outcome Measures
- Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC]) [Day 2 until 28 days post virus inoculation]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atea Study Site | Syracuse | New York | United States | 13215 |
Sponsors and Collaborators
- Atea Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Atea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT05366439
Other Study ID Numbers:
- AT-02A-003
First Posted:
May 9, 2022
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: