Clinical trial

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

Name

AT-02A-003

Description

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

Trial arms

Trial start

2022-04-22

Estimated PCD

2023-03-16

Trial end

2023-03-16

Status

Terminated

Phase

Early phase I

Treatment

AT-752

Parallel Assignment

Arms:

AT-752

Placebo Comparator

Parallel Assignment

Arms:

Placebo

Size

Primary endpoint

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

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

Updated at

2023-04-21

1 organization

2 products

1 indication

Organization

Product

Indication

Product