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Sponsor decision to deprioritize the dengue program
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AT-752 750-mg TID for 5 days | Active Comparator | Tablet; 750-mg, Three (3) times a day for 5-days |
|
| AT-752 Dose A for 5 days | Active Comparator | Tablet; Dose A, for 5-days |
|
| AT-752 Dose B for 5 days | Active Comparator | Tablet; Dose B, for 5-days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT-752 | Drug | AT-752 for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Endpoint | Maximum plasma concentration (Cmax) of AT-281 | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atea Study Site | Belo Horizonte | Brazil | ||||
| Atea Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | AT-752 750-mg TID for 5 Days | Tablet; 750-mg, Three (3) times a day for 5-days AT-752: AT-752 for 5 days |
| FG001 | Placebo TID for 5 Days | Tablet; Placebo, Three (3) times a day for 5-days Placebo: Placebo for 5 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original Protocol | Sep 20, 2021 |
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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
| Placebo | Drug | Placebo for 5 days |
|
| Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose |
| 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 | Brazil |
| Atea Study Site | Aguazul | Colombia |
| Atea Study Site | Antioquia | Colombia |
| Atea Study Site | Cali | Colombia |
| Atea Study Site | Girardot | Colombia |
| Atea Study Site | Yopal | Colombia |
| Atea Study Site | Machala | Ecuador |
| Atea Study Site | Guwahati | India |
| Atea Study Site | Kanpur | India |
| Atea Study Site | Lucknow | India |
| Atea Study Site | Sūrat | India |
| Atea Study Site | Kuala Terengganu | Malaysia |
| Atea Study Site | Perai | Malaysia |
| Atea Study Site | Ica | Peru |
| Atea Study Site | Iquitos | Peru |
| Atea Study Site | Iloilo City | Philippines |
| Atea Study Site | Las Piñas | Philippines |
| Atea Study Site | Quezon City | Philippines |
| Atea Study Site | Kaohsiung City | Taiwan |
| Atea Study Site | Bangkok | Thailand |
| Atea Study Site | Khon Kaen | Thailand |
| Atea Study Site | Hanoi | Vietnam |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AT-752 750-mg TID for 5 Days | Tablet; 750-mg, Three (3) times a day for 5-days AT-752: AT-752 for 5 days |
| BG001 | Placebo TID for 5 Days | Tablet; Placebo, Three (3) times a day for 5-days Placebo: Placebo for 5 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Number of subjects with available viral load for baseline and the particular post-baseline timepoint. | Posted | Mean | Standard Deviation | log10 copies/mL | Baseline, Day 2, Day 3, Day 4, Day 5, Day 6, Day 8, Day 14, Day 28 |
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| Secondary | Pharmacokinetic (PK) Endpoint | Maximum plasma concentration (Cmax) of AT-281 | PK Population | Posted | Mean | Standard Deviation | ng/mL | Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose |
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| Secondary | Pharmacokinetic (PK) Endpoint | Area under the concentration-time curve (AUCtau) of AT-281 | PK Population | Posted | Mean | Standard Deviation | h*ng/mL | Day 3: 0, 0.5, 1, 2, 4, 6 hours post-dose |
|
|
Day 28
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AT-752 750-mg TID for 5 Days | Tablet; 750-mg, Three (3) times a day for 5-days AT-752: AT-752 for 5 days | 0 | 14 | 1 | 14 | 10 | 14 |
| EG001 | Placebo TID for 5 Days | Tablet; Placebo, Three (3) times a day for 5-days Placebo: Placebo for 5 days | 0 | 7 | 1 | 7 | 6 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gingival bleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Euglycaemic diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| Hematocrit increased | Investigations | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Transfusion reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Phlebitis | Vascular disorders | Systematic Assessment |
|
Early discontinuation leading to small numbers of subjects analyzed.
Principal Investigator may publish or present results pertaining to the PI's activities after the first publication of the multicentre clinical trial results. Publications must be submitted for review by Sponsor before submission. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Atea Clinical Trials | Atea Pharmaceuticals, Inc. | 1-857-284-8891 | ateaclinicaltrials@ateapharma.com |
| Jan 16, 2024 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Jul 29, 2022 | Jan 16, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2022 | Jan 16, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D006482 | Hemorrhagic Fevers, Viral |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D001102 | Arbovirus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000728630 | AT-752 |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Thailand |
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| India |
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| Day 8 |
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| Day 14 |
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| Day 28 |
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