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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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