ISRCTN10496020已完成1 期
A randomized, double-blind, placebo-controlled dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single (intravenous infusion) and multiple (continuous intravenous infusion over 7 days) doses of KNS366 in healthy adult participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
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
- 性别
- All
入选标准
- •1. Male or female volunteers aged 18-55 years
- •2. Body mass index (BMI) of 18.5 to 32 kg/m²
- •3. Body weight >50 kg
- •4. Deemed healthy on the basis of medical history, clinical laboratory test results, vital sign measurements, ECG, and physical examination
- •5. Agree to follow the contraception requirements of the trial
- •6. Male participants must refrain from donating sperm during the treatment period and for at least 90 days following the last dose
- •7. Able to give fully informed consent
排除标准
- •1. Not healthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine)
- •2. A current or chronic history of liver disease or known hepatic or biliary abnormalities; history of or current evidence of cardiac arrhythmia, structural or mechanical heart disease, or cardiac conduction defect; a history or current evidence of depression, bipolar, suicidal ideation and behaviour; positive tests for hepatitis B and/or C, or human immunodeficiency virus (HIV)
- •3. Have used any prescription or over-the-counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 7 days (or 14 days if the medication is a potential enzyme inducer) before the first dose of study medicine; consumed grapefruit or grapefruit juice, Seville oranges or Seville orange-containing products (e.g., marmalade), exotic citrus fruits, red wine, or fruit juices from 7 days before the first dose of study medicine; consumed caffeine- or xanthine-containing products within 24 hours before the first dose of study medicine.
- •4. Have had a serious reaction to any medicine or have certain food allergies
- •5. Current smoker or used nicotine containing products within 6 months of screening; a history of alcohol abuse or drug addiction; strenuous activity within 48 hours of the first dose
- •6. Donated blood or have taken part in a study of an experimental medicine in the 3 months before first admission to the unit, or plan to do so in the 3 months after this study
- •7. Pregnant or lactating
研究者
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