NCT05466240
Terminated
Phase 2
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
ConditionsDengue Fever
Overview
- Phase
- Phase 2
- Intervention
- AT-752
- Conditions
- Dengue Fever
- Sponsor
- Atea Pharmaceuticals, Inc.
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in Dengue (DENV) Viral Load From Baseline
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
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.
Arms & Interventions
AT-752 750-mg TID for 5 days
Tablet; 750-mg, Three (3) times a day for 5-days
Intervention: AT-752
AT-752 750-mg TID for 5 days
Tablet; 750-mg, Three (3) times a day for 5-days
Intervention: Placebo
AT-752 Dose A for 5 days
Tablet; Dose A, for 5-days
Intervention: AT-752
AT-752 Dose A for 5 days
Tablet; Dose A, for 5-days
Intervention: Placebo
AT-752 Dose B for 5 days
Tablet; Dose B, for 5-days
Intervention: AT-752
AT-752 Dose B for 5 days
Tablet; Dose B, for 5-days
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Dengue (DENV) Viral Load From Baseline
Time Frame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28
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
Secondary Outcomes
- Pharmacokinetic (PK) Endpoint(Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose)
Study Sites (1)
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