Dengue FeverPhase 2NCT05466240

Study of AT-752 in Patients With Dengue Infection

A Phase 2 study testing AT-752 in people with Dengue Fever, run by Atea Pharmaceuticals, Inc. at 32 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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 Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Dengue Fever
What is being tested?: AT-752
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 32 sitesin 10 countries
Study dates: 29 Apr 2022to 19 Jan 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

32 sites in 10 countries.

Country

City, postcode or hospital

32 sites in 10 countries

Brazil11 sites

Atea Study Site
Belo Horizonte
Atea Study Site
Campo Grande
Atea Study Site
Cuiabá
Atea Study Site
Manaus
Atea Study Site
Natal
Atea Study Site
Porto Velho
Atea Study Site
Recife
Atea Study Site
Ribeirão Preto
Atea Study Site
Rio de Janeiro
Atea Study Site
São José do Rio Preto
Atea Study Site
São Paulo

Other trials in Brazil

Colombia5 sites

Atea Study Site
Aguazul
Atea Study Site
Antioquia
Atea Study Site
Cali
Atea Study Site
Girardot
Atea Study Site
Yopal

Other trials in Colombia

India4 sites

Atea Study Site
Guwahati
Atea Study Site
Kanpur
Atea Study Site
Lucknow
Atea Study Site
Sūrat

Other trials in India

Philippines3 sites

Atea Study Site
Iloilo City
Atea Study Site
Las Piñas
Atea Study Site
Quezon City

Other trials in Philippines

Malaysia2 sites

Atea Study Site
Kuala Terengganu
Atea Study Site
Perai

Other trials in Malaysia

Peru2 sites

Atea Study Site
Ica
Atea Study Site
Iquitos

Other trials in Peru

Thailand2 sites

Atea Study Site
Bangkok
Atea Study Site
Khon Kaen

Other trials in Thailand

Ecuador1 site

Atea Study Site
Machala

Other trials in Ecuador

Taiwan1 site

Atea Study Site
Kaohsiung City

Other trials in Taiwan

Vietnam1 site

Atea Study Site
Hanoi

Other trials in Vietnam

About this study

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

Conditions: Dengue Fever
Being tested: AT-752, Placebo
Keywords: Dengue, Vector borne disease, Infections, Virus disease, Viral, RNA virus, Hemorrhagic fevers
Medical subject headings: Dengue, Vector Borne Diseases, Infections, Virus Diseases, Hemorrhagic Fevers, Viral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AT-752Drug
AT-752 for 5 days
PlaceboDrug
Placebo for 5 days

Study groups in NCT05466240
Study group	Role	What they receive
AT-752 750-mg TID for 5 days	Active comparator	Tablet; 750-mg, Three (3) times a day for 5-days Receives: Drug: AT-752; Drug: Placebo
AT-752 Dose A for 5 days	Active comparator	Tablet; Dose A, for 5-days Receives: Drug: AT-752; Drug: Placebo
AT-752 Dose B for 5 days	Active comparator	Tablet; Dose B, for 5-days Receives: Drug: AT-752; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Apr 202219 Jan 2023

First posted20 Jul 2022
Study start29 Apr 2022
Primary completion19 Jan 2023
Study completion19 Jan 2023

Why it stopped: Sponsor decision to deprioritize the dengue program

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dengue FeverStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05466240
Sponsor's protocol ID: AT-02A-002
Status last verified: Feb 2024
First submitted: 21 Jun 2022
Last updated: 5 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs

All Dengue Fever trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05466240
Acronym / sponsor ID: AT-02A-002
Conditions: Dengue Fever
Keywords: Dengue, Vector borne disease, Infections, Virus disease, Viral, RNA virus, Hemorrhagic fevers
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision to deprioritize the dengue program
Enrolment: 21 participants (actual)
Lead sponsor: Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 29 Apr 2022 (actual)
Primary completion: 19 Jan 2023 (actual)
Study completion: 19 Jan 2023 (actual)
First posted: 20 Jul 2022 (actual)
Results: Posted 5 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
AT-752 750-mg TID for 5 days	Active comparator	Drug: AT-752, Drug: PlaceboTablet; 750-mg, Three (3) times a day for 5-days
AT-752 Dose A for 5 days	Active comparator	Drug: AT-752, Drug: PlaceboTablet; Dose A, for 5-days
AT-752 Dose B for 5 days	Active comparator	Drug: AT-752, Drug: PlaceboTablet; Dose B, for 5-days

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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 (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AT-752AT-752 for 5 days	Drug	AT-752 750-mg TID for 5 days, AT-752 Dose A for 5 days, AT-752 Dose B for 5 days
PlaceboPlacebo for 5 days	Drug	AT-752 750-mg TID for 5 days, AT-752 Dose A for 5 days, AT-752 Dose B for 5 days

Primary outcome

Change in Dengue (DENV) Viral Load From Baseline
Time frame: 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

2 secondary outcomes

Pharmacokinetic (PK) Endpoint
Time frame: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose
Pharmacokinetic (PK) Endpoint
Time frame: Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose

Results and safety

Results posted to the registry on 5 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AT-752 750-mg TID for 5 Days	14	12
Placebo TID for 5 Days	7	7

Primary outcome: Change in Dengue (DENV) Viral Load From Baseline

Time frame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28. Mean (Standard Deviation). Unit: log10 copies/mL

Measure	AT-752 750-mg TID for 5 Days n = 13	Placebo TID for 5 Days n = 7
Baseline Viral Load	5.8 (2.0)	4.6 (2.5)
Day 2	-1.3 (1.1)	-0.8 (0.9)
Day 3	-2.8 (1.3)	-1.2 (1.3)
Day 4	-3.3 (1.8)	-1.2 (1.7)
Day 5	-3.3 (1.8)	-1.8 (2.6)
Day 6	-3.3 (1.8)	-1.9 (2.5)
Day 8	-3.4 (1.8)	-1.9 (2.5)
Day 14	-3.3 (1.9)	-1.9 (2.5)

AT-752 750-mg TID for 5 Days vs Placebo TID for 5 Days: p <0.95, ANCOVA

Population analysed: Number of subjects with available viral load for baseline and the particular post-baseline timepoint.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 28. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AT-752 750-mg TID for 5 Days	1 of 14 (7.1%)	10 of 14 (71.4%)	0 of 14
Placebo TID for 5 Days	1 of 7 (14.3%)	6 of 7 (85.7%)	0 of 7

Limitations and caveats (from the sponsor): Early discontinuation leading to small numbers of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dengue Fever

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

32 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AT-752 in people with Dengue Fever, run by Atea Pharmaceuticals, Inc. at 32 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Brazil, Colombia, India, Philippines, Malaysia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dengue (DENV) Viral Load From Baseline (time frame: Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05466240.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.