Study Stopped
Sponsor decision to deprioritize the dengue program
Study of AT-752 in Patients With Dengue Infection
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
1 other identifier
interventional
21
10 countries
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2022
Shorter than P25 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 29, 2022
CompletedFirst Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2023
CompletedResults Posted
Study results publicly available
March 5, 2024
CompletedMarch 5, 2024
February 1, 2024
9 months
June 21, 2022
January 16, 2024
February 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Dengue (DENV) Viral Load From Baseline
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 Outcomes (2)
Pharmacokinetic (PK) Endpoint
Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
Pharmacokinetic (PK) Endpoint
Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
Study Arms (3)
AT-752 750-mg TID for 5 days
ACTIVE COMPARATORTablet; 750-mg, Three (3) times a day for 5-days
AT-752 Dose A for 5 days
ACTIVE COMPARATORTablet; Dose A, for 5-days
AT-752 Dose B for 5 days
ACTIVE COMPARATORTablet; Dose B, for 5-days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Atea Study Site
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
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
Machala, Ecuador
Atea Study Site
Guwahati, India
Atea Study Site
Kanpur, India
Atea Study Site
Lucknow, India
Atea Study Site
Sūrat, India
Atea Study Site
Kuala Terengganu, Malaysia
Atea Study Site
Perai, Malaysia
Atea Study Site
Ica, Peru
Atea Study Site
Iquitos, Peru
Atea Study Site
Iloilo City, Philippines
Atea Study Site
Las Piñas, Philippines
Atea Study Site
Quezon City, Philippines
Atea Study Site
Kaohsiung City, Taiwan
Atea Study Site
Bangkok, Thailand
Atea Study Site
Khon Kaen, Thailand
Atea Study Site
Hanoi, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early discontinuation leading to small numbers of subjects analyzed.
Results Point of Contact
- Title
- Atea Clinical Trials
- Organization
- Atea Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- 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
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2022
First Posted
July 20, 2022
Study Start
April 29, 2022
Primary Completion
January 19, 2023
Study Completion
January 19, 2023
Last Updated
March 5, 2024
Results First Posted
March 5, 2024
Record last verified: 2024-02