CTRI/2022/04/042131进行中（未招募）2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
- •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 <80,000/mm3 at the time of screening
- •17. Has any other medical disease or condition that in the opinion of the site principal investigator or appropriate sub-investigator, precludes study participation.
研究者
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