Clinical trial NCT05466240: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dengue Fever
Keywords: Dengue
Vector borne disease
Infections
Virus disease
Viral
RNA virus
Hemorrhagic fevers
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in Dengue (DENV) Viral Load From Baseline
timeFrame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28
Secondary outcomes:
measure: Pharmacokinetic (PK) Endpoint
timeFrame: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
measure: Pharmacokinetic (PK) Endpoint
timeFrame: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Atea Study Site
city: Campo Grande
country: Brazil
facility: Atea Study Site
city: Cuiabá
country: Brazil
facility: Atea Study Site
city: Manaus
country: Brazil
facility: Atea Study Site
city: Natal
country: Brazil
facility: Atea Study Site
city: Porto Velho
country: Brazil
facility: Atea Study Site
city: Recife
country: Brazil
facility: Atea Study Site
city: Ribeirão Preto
country: Brazil
facility: Atea Study Site
city: Rio de Janeiro
country: Brazil
facility: Atea Study Site
city: São José Do Rio Preto
country: Brazil
facility: Atea Study Site
city: São Paulo
country: Brazil
facility: Atea Study Site
city: Aguazul
country: Colombia
facility: Atea Study Site
city: Antioquia
country: Colombia
facility: Atea Study Site
city: Cali
country: Colombia
facility: Atea Study Site
city: Girardot
country: Colombia
facility: Atea Study Site
city: Yopal
country: Colombia
facility: Atea Study Site
city: Machala
country: Ecuador
facility: Atea Study Site
city: Guwahati
country: India
facility: Atea Study Site
city: Kanpur
country: India
facility: Atea Study Site
city: Lucknow
country: India
facility: Atea Study Site
city: Sūrat
country: India
facility: Atea Study Site
city: Kuala Terengganu
country: Malaysia
facility: Atea Study Site
city: Perai
country: Malaysia
facility: Atea Study Site
city: Ica
country: Peru
facility: Atea Study Site
city: Iquitos
country: Peru
facility: Atea Study Site
city: Iloilo City
country: Philippines
facility: Atea Study Site
city: Las Piñas
country: Philippines
facility: Atea Study Site
city: Quezon City
country: Philippines
facility: Atea Study Site
city: Kaohsiung City
country: Taiwan
facility: Atea Study Site
city: Bangkok
country: Thailand
facility: Atea Study Site
city: Khon Kaen
country: Thailand
facility: Atea Study Site
city: Hanoi
country: Vietnam
facility: Atea Study Site
Study officials:
References: