Health Condition 1: A90- Dengue fever [classical dengue]
Conditions
Interventions
Intervention1: AT-752: Route of administration :
Cohort 1: 750 m g AT-752/placebo TID for 5 days
Cohort 2: up to 1000 m g AT-752/placebo BID or TID for 5 days
Cohort 3: up to 1500 mg AT-752/placebo
Sponsors
Atea Pharmaceuticals Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. 18 to 55 years of age at time of screening 2. Fever =38°C (or feeling feverish) with onset during the previous 48 hours 3. Live or work in or recent travel to dengue endemic area 4. Positive test confirming DENV on a NS1 antigen test or reverse transcription-polymerase chain reaction (RT-PCR) assay 5. Negative rapid diagnostic test result for SARS-CoV-2 and Influenza A and B 6. Body mass index (BMI) of 18 to 30 kg/m2 7. Provides written informed consent prior to initiation of any study procedures 8. Able to understand and agrees to comply with planned study procedures and be available for all study visits 9. Males and females of childbearing potential must agree to use protocol-specified methods of contraception as described in Protocol Section 4.1.1 10. Male subjects must agree to not donate sperm from the first dose through 90 days after the last dose of study drug
Exclusion criteria
Exclusion criteria: 1. Pregnant at screening or plans to become pregnant within 90 days of screening 2. Female patient who is breastfeeding or plans to breastfeed during the study period 3. Has previously received any investigational or approved vaccine for dengue 4. Previous history of HIV, chronic hepatitis B infection, or current hepatitis C infection 5. Use of any antiviral drug within 30 days or within 5 half-lives of the active drug or metabolite 6. Currently enrolled in or plans to participate in another clinical trial with an investigational agent or device that will be received during the study-reporting period 7. Exposure to another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to study drug administration 8. Use of herbal or dietary supplements or grapefruit juice within 7 days of screening 9. Patients with chronic medical conditions that put them at risk for severe dengue, including uncontrolled diabetes mellitus, severe asthma requiring oral steroids, or admission to the hospital in the previous 6 months for cardiac disease. 10. Current use of anticoagulant or antiplatelet drugs or documented medical history of bleeding disorders 11. Current use of medications for treatment of inflammatory bowel disease or documented medical history of chronic gastrointestinal disease including inflammatory bowel disease 12. Immunocompromised due to use of immunosuppressive drugs including systemic corticosteroids or any current disease or condition 13. Evidence of severe dengue disease including severe plasma leakage leading to shock or fluid accumulation with respiratory distress, severe bleeding, severe organ impairment 14. Suspected or confirmed acute illness thought to be caused by a pathogen other than DENV 15. Confirmed or suspected SARS-CoV-2 infection or contact with patients with confirmed SARS-CoV2 infection within 7 days prior to screening 16. ALT or AST > 5x upper limit of normal or total bilirubin > 1.5x ULN or platelet count 17. Has any other medical disease or condition that in the opinion of the site principal investigator or appropriate sub-investigator, precludes study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 infectionTimepoint: Change in DENV viral load from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety objective of this study is: • To evaluate safety of AT-752 versus placebo assessed by TEAEs, serious adverse events (SAEs), physical exams, vital signs, clinical laboratory assessments (including serum chemistry, coagulation, hematology), and ECG results in adult subjects with confirmed DENV infectionTimepoint: 1. Incidence and grade of any TEAEs from first dose through Day 28 or withdrawal from the study 2. Incidence and grade of any SAEs through Day 28 or withdrawal from the study 3. Vital sign measurements 4. Physical examination findings 5. Clinical laboratory (serum chemistry, hematology, coagulation, and urinalysis findings) 6. ECG;To evaluate the PK of AT-752 (AT-281) and metabolites in adult subjects with confirmed DENV infection. Timepoint: PK endpoints will be characterized as subject numbers and PK data permit. • Plasma concentrations of AT-281 and metabolites at Day 1 at time 0, 24 hours after Dose 1, A day of intensive PK sampling • For TID dosing, samples obtained before Dose 7 and 0.5, 1, 2, 4, and 6 hours after Dose 7. • For BID dosing, samples obtained before Dose 5 and 0.5, 1, 2, 4, 6, and 8 hours after Dose 5. | — |
Countries
Brazil, Colombia, Ecuador, India, Malaysia, Peru, Philippines, Taiwan, Thailand, Viet Nam
Contacts
Public ContactRashmi Chitgupi
PPD Pharmaceutical Development India Private Limited
Outcome results
None listed