Study of AT-752 in Patients With Dengue Infection

February 7, 2024 updated by: Atea Pharmaceuticals, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Belo Horizonte, Brazil
        • Atea Study Site
      • Campo Grande, Brazil
        • Atea Study Site
      • Cuiabá, Brazil
        • Atea Study Site
      • Manaus, Brazil
        • Atea Study Site
      • Natal, Brazil
        • Atea Study Site
      • Porto Velho, Brazil
        • Atea Study Site
      • Recife, Brazil
        • Atea Study Site
      • Ribeirão Preto, Brazil
        • Atea Study Site
      • Rio de Janeiro, Brazil
        • Atea Study Site
      • São José Do Rio Preto, Brazil
        • Atea Study Site
      • São Paulo, Brazil
        • Atea Study Site
  • Colombia
      • Aguazul, Colombia
        • Atea Study Site
      • Antioquia, Colombia
        • Atea Study Site
      • Cali, Colombia
        • Atea Study Site
      • Girardot, Colombia
        • Atea Study Site
      • Yopal, Colombia
        • Atea Study Site
  • Ecuador
      • Machala, Ecuador
        • Atea Study Site
  • India
      • Guwahati, India
        • Atea Study Site
      • Kanpur, India
        • Atea Study Site
      • Lucknow, India
        • Atea Study Site
      • Sūrat, India
        • Atea Study Site
  • Malaysia
      • Kuala Terengganu, Malaysia
        • Atea Study Site
      • Perai, Malaysia
        • Atea Study Site
  • Peru
      • Ica, Peru
        • Atea Study Site
      • Iquitos, Peru
        • Atea Study Site
  • Philippines
      • Iloilo City, Philippines
        • Atea Study Site
      • Las Piñas, Philippines
        • Atea Study Site
      • Quezon City, Philippines
        • Atea Study Site
  • Taiwan
      • Kaohsiung City, Taiwan
        • Atea Study Site
  • Thailand
      • Bangkok, Thailand
        • Atea Study Site
      • Khon Kaen, Thailand
        • Atea Study Site
  • Vietnam
      • Hanoi, Vietnam
        • Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) Endpoint
Time Frame: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
Maximum plasma concentration (Cmax) of AT-281
Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
Pharmacokinetic (PK) Endpoint
Time Frame: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
Area under the concentration-time curve (AUCtau) of AT-281
Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2022

Primary Completion (Actual)

January 19, 2023

Study Completion (Actual)

January 19, 2023

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-02A-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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