Study of AT-752 in Patients With Dengue Infection

Dengue Fever Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05466240
• Other study ID #: AT-02A-002
• Status: Terminated
• Phase: Phase 2
• Start date: April 29, 2022
• Est. completion date: January 19, 2023

Study information

• Verified date: February 2024
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dengue
• Dengue Fever
• Infections

Intervention

Drug:
• AT-752
AT-752 for 5 days
• Placebo
Placebo for 5 days

Locations

Country	Name	City	State
Brazil	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
Colombia	Atea Study Site	Aguazul
Colombia	Atea Study Site	Antioquia
Colombia	Atea Study Site	Cali
Colombia	Atea Study Site	Girardot
Colombia	Atea Study Site	Yopal
Ecuador	Atea Study Site	Machala
India	Atea Study Site	Guwahati
India	Atea Study Site	Kanpur
India	Atea Study Site	Lucknow
India	Atea Study Site	Surat
Malaysia	Atea Study Site	Kuala Terengganu
Malaysia	Atea Study Site	Perai
Peru	Atea Study Site	Ica
Peru	Atea Study Site	Iquitos
Philippines	Atea Study Site	Iloilo City
Philippines	Atea Study Site	Las Piñas
Philippines	Atea Study Site	Quezon City
Taiwan	Atea Study Site	Kaohsiung City
Thailand	Atea Study Site	Bangkok
Thailand	Atea Study Site	Khon Kaen
Vietnam	Atea Study Site	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Brazil,  Colombia,  Ecuador,  India,  Malaysia,  Peru,  Philippines,  Taiwan,  Thailand,  Vietnam, 

Outcome

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