Study of AT-752 in Patients With Dengue Infection
Primary Purpose
Dengue Fever
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AT-752
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dengue Fever focused on measuring Dengue, Vector borne disease, Infections, Virus disease, Viral, RNA virus, Hemorrhagic fevers
Eligibility Criteria
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.
Sites / Locations
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
- Atea Study Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
AT-752 750-mg TID for 5 days
AT-752 Dose A for 5 days
AT-752 Dose B for 5 days
Arm Description
Tablet; 750-mg, Three (3) times a day for 5-days
Tablet; Dose A, for 5-days
Tablet; Dose B, for 5-days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Pharmacokinetic (PK) endpoint
Maximum plasma concentration (Cmax)
Pharmacokinetic (PK) endpoint
Area under the concentration-time curve (AUC)
Evaluate safety of AT-752 versus placebo assessed by Treatment Emergent Adverse Events (TEAEs), serious adverse events (SAEs)
Proportion of Participants with Treatment Emergent Adverse Events (TEAEs) Proportion of Participants with Serious Adverse Events (SAEs)
Full Information
NCT ID
NCT05466240
First Posted
June 21, 2022
Last Updated
March 17, 2023
Sponsor
Atea Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05466240
Brief Title
Study of AT-752 in Patients With Dengue Infection
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to deprioritize the dengue program
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atea Pharmaceuticals, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever
Keywords
Dengue, Vector borne disease, Infections, Virus disease, Viral, RNA virus, Hemorrhagic fevers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AT-752 750-mg TID for 5 days
Arm Type
Active Comparator
Arm Description
Tablet; 750-mg, Three (3) times a day for 5-days
Arm Title
AT-752 Dose A for 5 days
Arm Type
Active Comparator
Arm Description
Tablet; Dose A, for 5-days
Arm Title
AT-752 Dose B for 5 days
Arm Type
Active Comparator
Arm Description
Tablet; Dose B, for 5-days
Intervention Type
Drug
Intervention Name(s)
AT-752
Intervention Description
AT-752 for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for 5 days
Primary Outcome Measure Information:
Title
Change in Dengue (DENV) viral load from Baseline
Description
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
Time Frame
Day 1 thru day 28
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) endpoint
Description
Maximum plasma concentration (Cmax)
Time Frame
Day 1 thru day 5
Title
Pharmacokinetic (PK) endpoint
Description
Area under the concentration-time curve (AUC)
Time Frame
Day 1 thru day 5
Title
Evaluate safety of AT-752 versus placebo assessed by Treatment Emergent Adverse Events (TEAEs), serious adverse events (SAEs)
Description
Proportion of Participants with Treatment Emergent Adverse Events (TEAEs) Proportion of Participants with Serious Adverse Events (SAEs)
Time Frame
Day 1 thru day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Atea Study Site
City
Belo Horizonte
Country
Brazil
Facility Name
Atea Study Site
City
Campo Grande
Country
Brazil
Facility Name
Atea Study Site
City
Cuiabá
Country
Brazil
Facility Name
Atea Study Site
City
Manaus
Country
Brazil
Facility Name
Atea Study Site
City
Natal
Country
Brazil
Facility Name
Atea Study Site
City
Porto Velho
Country
Brazil
Facility Name
Atea Study Site
City
Recife
Country
Brazil
Facility Name
Atea Study Site
City
Ribeirão Preto
Country
Brazil
Facility Name
Atea Study Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Atea Study Site
City
São José Do Rio Preto
Country
Brazil
Facility Name
Atea Study Site
City
São Paulo
Country
Brazil
Facility Name
Atea Study Site
City
Aguazul
Country
Colombia
Facility Name
Atea Study Site
City
Antioquia
Country
Colombia
Facility Name
Atea Study Site
City
Cali
Country
Colombia
Facility Name
Atea Study Site
City
Girardot
Country
Colombia
Facility Name
Atea Study Site
City
Yopal
Country
Colombia
Facility Name
Atea Study Site
City
Machala
Country
Ecuador
Facility Name
Atea Study Site
City
Guwahati
Country
India
Facility Name
Atea Study Site
City
Kanpur
Country
India
Facility Name
Atea Study Site
City
Lucknow
Country
India
Facility Name
Atea Study Site
City
Sūrat
Country
India
Facility Name
Atea Study Site
City
Kuala Terengganu
Country
Malaysia
Facility Name
Atea Study Site
City
Perai
Country
Malaysia
Facility Name
Atea Study Site
City
Ica
Country
Peru
Facility Name
Atea Study Site
City
Iquitos
Country
Peru
Facility Name
Atea Study Site
City
Iloilo City
Country
Philippines
Facility Name
Atea Study Site
City
Las Piñas
Country
Philippines
Facility Name
Atea Study Site
City
Quezon City
Country
Philippines
Facility Name
Atea Study Site
City
Kaohsiung City
Country
Taiwan
Facility Name
Atea Study Site
City
Bangkok
Country
Thailand
Facility Name
Atea Study Site
City
Khon Kaen
Country
Thailand
Facility Name
Atea Study Site
City
Hanoi
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Study of AT-752 in Patients With Dengue Infection
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