A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of Kylo-0603 Capsules in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- incidence of adverse events
研究概览
简要总结
This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.
详细描述
The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 55 years old, inclusive;
- •Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive；
- •Having no clinically significant disorder, condition or disease at screening and before first dosing;
- •Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
- •Willing to comply with protocol required visits and assessments, and provide written informed consent.
排除标准
- •History of cardiovascular, respiratory, digestive, liver, urinary, hematological, endocrine, metabolic, immune, cutaneous, or psychoneurotic diseases；
- •History of evidence of malignant tumor or Gilbert syndrome;
- •Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
- •History of tuberculosis infection;
- •History of alcohol abuse within 12 months before dosing;
- •History of drug abuse within 3 months before screening;
- •History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
- •Pregnant or breast-feeding women;
- •Other exclusion criteria applied per protocol.
研究组 & 干预措施
Kylo-0603
In part 1, subjects will receive single dose Kylo-0603 orally at dose levels of 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg, 4.6 mg, 8.6 mg, 12 mg, 16 mg and 20 mg on Day 1. In part 2, subjects will receive Kylo-0603 4.6 mg on Day 1 in fasted state and on Day 4 after a standard high-fat meal. In part 3, subject will receive Kylo-0603 orally once daily for 14 days at dose levels of 1.2 mg, 2 mg, 4 mg, 8 mg, 12 mg, and 16 mg.
干预措施: Kylo-0603 capsule (Drug)
Placebo
Subjects will receive matching placebo in part 1, part 2 and part 3.
干预措施: Placebo (Drug)
结局指标
主要结局
incidence of adverse events
时间窗: up to 3 weeks
次要结局
- PK parameter of area under the concentration time curve (AUC)(up to 3 weeks)
- Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)(up to 3 weeks)
- PK parameter of time of maximum observed concentration (Tmax)(up to 3 weeks)