A Phase I Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of NTP42:KVA4 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers.
研究概览
简要总结
A Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of NTP42:KVA4 following oral administration in a randomized, double-blind, placebo-controlled trial. The trial will involve of 2 phases, a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. The SAD phase will incorporate a food effect arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A body mass index (BMI) in the range 18.0-30.
- •Ability & willingness to provide written consent.
排除标准
- •Clinically relevant abnormal medical history, physical findings, laboratory values at pre-trial screening.
- •History of bleeding disorders, coagulation variables or abnormal blood cell count.
- •History of chronic illness.
- •Impaired endocrine, thyroid, hepatic, renal or respiratory function, diabetes mellitus, coronary heart disease or history of any psychotic mental illness.
- •History of adverse reaction or allergy to any drug.
- •Use of aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any other medicine that affects platelet function or coagulation, or any prescription medicine, during the 28 days before the first dose of trial medication.
- •History of drug or alcohol abuse
- •Smoker or use of nicotine-containing products
- •Blood pressure or heart rate at screening outside normal ranges.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the safety and tolerability of single and repeated doses of NTP42:KVA4 in healthy volunteers.
时间窗: Up to 48-hour post-dose.
Adverse events (AEs)
Evaluation of the effect of food on the pharmacokinetics of NTP42:KVA4 in healthy volunteers.
时间窗: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
Pharmacokinetic parameter: Area under the Curve (AUC)
Evaluation of the pharmacokinetics of single and repeated doses of NTP42:KVA4 in healthy volunteers.
时间窗: Predose, 0.16, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 18, 24, 36 & 48 hours post-dosing.
Pharmacokinetic parameter: Area under the Curve (AUC)
次要结局
- Evaluation of the pharmacodynamics effects of NTP42:KVA4 in healthy volunteers.(Predose, 0.75, 2, 4, 8, 12 & 24 hours post-dosing)