Study of AT-752 in Patients With Dengue Infection

Phase 2

Terminated

• Conditions: Dengue Fever
• Interventions: Drug: AT-752; Drug: Placebo

• Registration Number: NCT05466240
• Lead Sponsor: Atea Pharmaceuticals, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-29
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Results First Submitted: 2024-01-16
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Results First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AT-752 Dose A for 5 days	AT-752	Tablet; Dose A, for 5-days
AT-752 Dose A for 5 days	Placebo	Tablet; Dose A, for 5-days
AT-752 Dose B for 5 days	AT-752	Tablet; Dose B, for 5-days
AT-752 Dose B for 5 days	Placebo	Tablet; Dose B, for 5-days
AT-752 750-mg TID for 5 days	Placebo	Tablet; 750-mg, Three (3) times a day for 5-days
AT-752 750-mg TID for 5 days	AT-752	Tablet; 750-mg, Three (3) times a day for 5-days

Primary Outcome Measures

Name	Time	Method
Change in Dengue (DENV) Viral Load From Baseline	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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Endpoint	Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose	Area under the concentration-time curve (AUCtau) of AT-281

Trial Locations

Locations (1)

Atea Study Site; 🇻🇳 Hanoi, Vietnam