Study of AT-752 in Patients With Dengue Infection

Atea Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Dengue Fever

Treatments: Drug: AT-752; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05466240

AT-02A-002

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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21 participants in 3 patient groups

AT-752 750-mg TID for 5 days

Active Comparator group

Description:

Tablet; 750-mg, Three (3) times a day for 5-days

Treatment:

Drug: AT-752

Drug: Placebo

AT-752 Dose A for 5 days

Active Comparator group

Description:

Tablet; Dose A, for 5-days

Treatment:

Drug: AT-752

Drug: Placebo

AT-752 Dose B for 5 days

Active Comparator group

Description:

Tablet; Dose B, for 5-days

Treatment:

Drug: AT-752

Drug: Placebo