NCT05366439

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2023

Completed
Last Updated

April 21, 2023

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

May 5, 2022

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean quantitative RNAemia (peak and duration and area under the plasma concentration versus time curve [AUC])

    Day 2 until 28 days post virus inoculation

Study Arms (2)

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

AT-752DRUG

Parallel Assignment

AT-752

Parallel Assignment

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or breastfeeding
  • Abuse of drugs
  • Other clinically significant medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

Syracuse, New York, 13215, United States

Location

MeSH Terms

Conditions

Dengue

Interventions

AT-752

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 9, 2022

Study Start

April 22, 2022

Primary Completion

March 16, 2023

Study Completion

March 16, 2023

Last Updated

April 21, 2023

Record last verified: 2022-05

Locations