Study of AT-752 in Patients With Dengue Infection

Study Overview
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Brief Summary
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The Phase 2 study will be conducted in adult patients with confirmed Dengue infection and will investigate safety, PK, and pharmacodynamics (PD) in this population. The study will be conducted in several dosing cohorts to enable dose selection for subsequent trials

Official Title
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A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate Pharmacokinetics, Pharmacodynamics, and Safety of AT-752 in Patients With Dengue Infection

Conditions
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Dengue Fever

Intervention / Treatment
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* Drug: AT-752
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 18-55 years of age at time of screening Fever ≥38°C (or feeling feverish) with onset during the previous 48 hours Live/work in or recent travel to dengue endemic area Positive test confirming Dengue (DENV) on a NS1 antigen test or reverse transcription-polymerase chain reaction (RT-PCR) assay Negative rapid diagnostic test result for Coronavirus (SARS-CoV-2) and Influenza A and B Key Exclusion Criteria: Pregnant, plans to become pregnant within 90 days of screening, or breast feeding. Has previously received any investigational or approved vaccine for dengue Previous history of HIV, chronic hepatitis B infection, or current hepatitis C infection (from medical history) Use of any antiviral drug within 30 days or within 5 half-lives of the active drug or metabolite (for long-acting antivirals) Current use of anticoagulant or antiplatelet drugs or documented medical history of bleeding disorders Current use of medications for treatment of inflammatory bowel disease or documented medical history of chronic gastrointestinal disease including inflammatory bowel disease Immunocompromised due to use of immunosuppressive drugs including systemic corticosteroids (inhaled or topical corticosteroids are allowed) or any current disease or condition Evidence of severe dengue disease Confirmed or suspected Coronavirus (SARS-CoV-2) infection or contact with patients with confirmed SARS-CoV2 infection within 7 days prior to screening Other clinically significant medical conditions or laboratory abnormalities, as described in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AT-752 750-mg TID for 5 days<br>Tablet; 750-mg, Three (3) times a day for 5-days | Drug: AT-752<br>* AT-752 for 5 days<br>Drug: Placebo<br>* Placebo for 5 days<br>|
| Active Comparator: AT-752 Dose A for 5 days<br>Tablet; Dose A, for 5-days | Drug: AT-752<br>* AT-752 for 5 days<br>Drug: Placebo<br>* Placebo for 5 days<br>|
| Active Comparator: AT-752 Dose B for 5 days<br>Tablet; Dose B, for 5-days | Drug: AT-752<br>* AT-752 for 5 days<br>Drug: Placebo<br>* Placebo for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Dengue (DENV) viral load from Baseline | To investigate the antiviral activity of AT-752 versus placebo in terms of reduction of DENV RNA from baseline in adult subjects with confirmed DENV infection | Day 1 thru day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) endpoint | Maximum plasma concentration (Cmax) | Day 1 thru day 5 | 
| Pharmacokinetic (PK) endpoint | Area under the concentration-time curve (AUC) | Day 1 thru day 5 | 
| Evaluate safety of AT-752 versus placebo assessed by Treatment Emergent Adverse Events (TEAEs), serious adverse events (SAEs) | Proportion of Participants with Treatment Emergent Adverse Events (TEAEs) Proportion of Participants with Serious Adverse Events (SAEs) | Day 1 thru day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dengue, Vector borne disease, Infections, Virus disease, Viral, RNA virus, Hemorrhagic fevers