Study of AT-752 in Patients With Dengue Infection

Sponsor

Atea Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05466240

Collaborator

(none)

Enrollment

Locations

Arms

8.1

Anticipated Duration (Months)

1.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Dengue Fever	Drug: AT-752 750-mg Drug: AT-752 Dose A Drug: AT-752 Dose B Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

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

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 29, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AT-752 750-mg TID for 5 days	Drug: AT-752 750-mg AT-752 750-mg TID for 5 days Drug: Placebo Placebo for 5 days
Active Comparator: AT-752 Dose A for 5 days	Drug: AT-752 Dose A AT-752 Dose A for 5 days Drug: Placebo Placebo for 5 days
Active Comparator: AT-752 Dose B for 5 days	Drug: AT-752 Dose B AT-752 for 5 days Drug: Placebo Placebo for 5 days
Active Comparator: Placebo for 5 days	Drug: AT-752 750-mg AT-752 750-mg TID for 5 days Drug: AT-752 Dose A AT-752 Dose A for 5 days Drug: AT-752 Dose B AT-752 for 5 days

Outcome Measures

Primary Outcome Measures

Change in DENV viral load from Baseline [Day 1 thru 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

Pharmacokinetic (PK) endpoint [Day 1 thru day 5]
Maximum plasma concentration (Cmax)
Pharmacokinetic (PK) endpoint [Day 1 thru day 5]
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) [Day 1 thru day 28]
Proportion of Participants with Treatment Emergent Adverse Events (TEAEs) Proportion of Participants with Serious Adverse Events (SAEs)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 DENV on a NS1 antigen test or reverse transcription-polymerase chain reaction (RT-PCR) assay
Negative rapid diagnostic test result for 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 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.

Contacts and Locations

Locations

	Site	City	Country
1	Atea Study Site	Belo Horizonte	Brazil
2	Atea Study Site	Campo Grande	Brazil
3	Atea Study Site	Cuiabá	Brazil
4	Atea Study Site	Manaus	Brazil
5	Atea Study Site	Natal	Brazil
6	Atea Study Site	Porto Velho	Brazil
7	Atea Study Site	Recife	Brazil
8	Atea Study Site	Ribeirão Preto	Brazil
9	Atea Study Site	Rio de Janeiro	Brazil
10	Atea Study Site	São José Do Rio Preto	Brazil
11	Atea Study Site	São Paulo	Brazil
12	Atea Study Site	Aguazul	Colombia
13	Atea Study Site	Antioquia	Colombia
14	Atea Study Site	Cali	Colombia
15	Atea Study Site	Girardot	Colombia
16	Atea Study Site	Yopal	Colombia
17	Atea Study Site	Machala	Ecuador
18	Atea Study Site	Guwahati	India
19	Atea Study Site	Kanpur	India
20	Atea Study Site	Lucknow	India
21	Atea Study Site	Sūrat	India
22	Atea Study Site	Kuala Terengganu	Malaysia
23	Atea Study Site	Perai	Malaysia
24	Atea Study Site	Ica	Peru
25	Atea Study Site	Iquitos	Peru
26	Atea Study Site	Iloilo City	Philippines
27	Atea Study Site	Las Piñas	Philippines
28	Atea Study Site	Quezon City	Philippines
29	Atea Study Site	Kaohsiung City	Taiwan
30	Atea Study Site	Bangkok	Thailand
31	Atea Study Site	Khon Kaen	Thailand
32	Atea Study Site	Hanoi	Vietnam