Study of AT-752 in Patients With Dengue Infection

NCT ID: NCT05466240

Last Updated: 2024-03-05

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-29

Study Completion Date

2023-01-19

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

Detailed Description

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Conditions

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Dengue Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Eligible subjects will be randomized to receive either AT-752 or matching placebo orally 3 times a day (TID) for 5 days in Cohort 1 of the study.

Subsequent cohorts will receive AT-752/placebo either twice a day (BID) or TID

Study Groups

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AT-752 750-mg TID for 5 days

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

Group Type ACTIVE_COMPARATOR

AT-752

Intervention Type DRUG

AT-752 for 5 days

Placebo

Intervention Type DRUG

Placebo for 5 days

AT-752 Dose A for 5 days

Tablet; Dose A, for 5-days

Group Type ACTIVE_COMPARATOR

AT-752

Intervention Type DRUG

AT-752 for 5 days

Placebo

Intervention Type DRUG

Placebo for 5 days

AT-752 Dose B for 5 days

Tablet; Dose B, for 5-days

Group Type ACTIVE_COMPARATOR

AT-752

Intervention Type DRUG

AT-752 for 5 days

Placebo

Intervention Type DRUG

Placebo for 5 days

Interventions

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AT-752

AT-752 for 5 days

Intervention Type DRUG

Placebo

Placebo for 5 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Belo Horizonte, , Brazil

Site Status

Atea Study Site

Campo Grande, , Brazil

Site Status

Atea Study Site

Cuiabá, , Brazil

Site Status

Atea Study Site

Manaus, , Brazil

Site Status

Atea Study Site

Natal, , Brazil

Site Status

Atea Study Site

Porto Velho, , Brazil

Site Status

Atea Study Site

Recife, , Brazil

Site Status

Atea Study Site

Ribeirão Preto, , Brazil

Site Status

Atea Study Site

Rio de Janeiro, , Brazil

Site Status

Atea Study Site

São José do Rio Preto, , Brazil

Site Status

Atea Study Site

São Paulo, , Brazil

Site Status

Atea Study Site

Aguazul, , Colombia

Site Status

Atea Study Site

Antioquia, , Colombia

Site Status

Atea Study Site

Cali, , Colombia

Site Status

Atea Study Site

Girardot, , Colombia

Site Status

Atea Study Site

Yopal, , Colombia

Site Status

Atea Study Site

Machala, , Ecuador

Site Status

Atea Study Site

Guwahati, , India

Site Status

Atea Study Site

Kanpur, , India

Site Status

Atea Study Site

Lucknow, , India

Site Status

Atea Study Site

Sūrat, , India

Site Status

Atea Study Site

Kuala Terengganu, , Malaysia

Site Status

Atea Study Site

Perai, , Malaysia

Site Status

Atea Study Site

Ica, , Peru

Site Status

Atea Study Site

Iquitos, , Peru

Site Status

Atea Study Site

Iloilo City, , Philippines

Site Status

Atea Study Site

Las Piñas, , Philippines

Site Status

Atea Study Site

Quezon City, , Philippines

Site Status

Atea Study Site

Kaohsiung City, , Taiwan

Site Status

Atea Study Site

Bangkok, , Thailand

Site Status

Atea Study Site

Khon Kaen, , Thailand

Site Status

Atea Study Site

Hanoi, , Vietnam

Site Status

Countries

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Brazil Colombia Ecuador India Malaysia Peru Philippines Taiwan Thailand Vietnam

Provided Documents

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Document Type: Study Protocol: Original Protocol

View Document

Document Type: Study Protocol: Amendment 1

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AT-02A-002

Identifier Type: -

Identifier Source: org_study_id

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