Study of AT-752 in Healthy Subjects in a Dengue Human Cha... | NCT05366439

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

NCT05366439

Sponsor

Atea Pharmaceuticals, Inc.

Status

Terminated

Last Update Posted

Apr 21, 2023Actual

Enrollment

5Actual

Phase

Phase 1

Conditions

Dengue

Interventions

AT-752
Placebo Comparator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision to deprioritize the dengue program

Expanded Access Info

Start Date

Apr 22, 2022Actual

Primary Completion Date

Mar 16, 2023Actual

Completion Date

Mar 16, 2023Actual

First Submitted Date

May 5, 2022

First Submission Date that Met QC Criteria

May 5, 2022

First Posted Date

May 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2023

Last Update Posted Date

Apr 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AT-752	Experimental	AT-752 administered orally for 14 days	Drug: AT-752
Placebo	Placebo Comparator	Matching placebo administered orally for 14 days	Drug: Placebo Comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AT-752	Drug	Parallel Assignment	AT-752
Placebo Comparator

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Atea Study Site		Syracuse	New York	13215	United States

Condition Browse Module

MeSH Terms

ID	Term
D003715	Dengue

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000728630	AT-752

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided