A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of KLA578-1 for Injection in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single and multiple doses of KLA578-1 for injection in healthy volunteers
详细描述
"The study will be carried out in 2 parts. Part 1: This is a open-label, single ascending dose (SAD) escalation study with a total of 3 dose groups, i.e., Groups 1 to 3. There are a total of 12 volunteers in each group with a similar male to female ratio. Groups 1 and 3 are single-arm study, all volunteers will receive the experimental drug ""KLA578-1 for Injection"" ; Group 2 is a randomized, two-treatment, two-period, crossover study, 12 volunteers will be randomized to TR sequence or RT sequence with 6 volunteers in each sequence. The experimental drug ""KLA578-1 for injection"" will be administered in the TR sequence of Period 1, the control drug ""Etopcoxib Tablets"" will be administered to the RT sequence. After 7 days of washing, the control drug ""Etocoxib Tablets"" will be administered in the TR sequence, and the experimental drug ""KLA578-1 for Injection"" will be administered in the RT sequence.
Part 2: This is a open-label, single-arm multiple dose study. A dose group is temporarily set up, with a total of 12 volunteers enrolled, and the male-to-female ratio will be similar. Volunteers will receive the experimental drug ""KLA578-1 for Injection"" 120 mg once daily (every 24 h ± 2 min with reference to the dosing time on D1) under fasting conditions (fasting for at least 10 hours) from D1 to D5; Drinking water is prohibited from 1 h before each dose to 1 h postdose, and fasted within 4 hours after dosing on D1 and D5."
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health Volunteers (Age: 18~45 years);
- •Body Weight: Male≥50.0kg, Female≥45.0kg; 19.0 ≤BMI≤ 26.0;
- •There were no abnormalities in clinically significant physical examination, vital signs, 12-lead electrocardiogram, laboratory tests;
- •Heart rate ≥ 60 bpm and pulse ≥ 60 beats/min.
排除标准
- •Allergy or Drug hypersensitivity;
- •Clinically significant Medical History;
- •Gastrointestinal ulcers or gastrointestinal bleeding;
- •History of any surgery within 4 weeks;
- •History of any Medication within 14 days;
- •History of any inducers or inhibitors of major CYP450 enzymes within 30 days;
- •History of any clinical study within 3 months;
- •History of any vaccine within 1 month;
- •History of any drug abuse;
- •Tablet dysphagia;
- •Needle sickness, Hematosickness;
- •Massive blood loss (> 200 mL) in the past 3 months;
- •Female volunteers are pregnant or lactating;
- •History of unprotected sex within 2 weeks;
- •Special requirements for diet;
- •Heavy smoker ( more than 3 cigarettes/day) within 3 months;
- •History of alcohol abuse,or heavy alcohol intake (more than 14 units a week) within 6 months;
- •Heavy caffeine intake;
- •History of grapefruit, xanthine-rich foods intake within 7 days;
- •Positive alcohol test;
- •Positive drugs of abuse test result.
研究组 & 干预措施
KLA578-1 60mg
12 volunteers receive KLA578-1 for injection 60mg
干预措施: KLA578-1 for injection (Drug)
KLA578-1 240mg
12 volunteers receive KLA578-1 for injection 240mg
干预措施: KLA578-1 for injection (Drug)
KLA578-1 120mg
Period 1, 6 volunteers receive KLA578-1 for injection 120mg → 6 volunteers receive Etopcoxib Tablets 120mg; Period 2, 6 volunteers receive Etopcoxib Tablets 120mg → 6 volunteers receive KLA578-1 for injection 120mg
干预措施: KLA578-1 for injection (Drug)
KLA578-1 120mg
Period 1, 6 volunteers receive KLA578-1 for injection 120mg → 6 volunteers receive Etopcoxib Tablets 120mg; Period 2, 6 volunteers receive Etopcoxib Tablets 120mg → 6 volunteers receive KLA578-1 for injection 120mg
干预措施: Etopcoxib Tablets (Drug)
multiple doses of KLA578-1 for injection
12 volunteers receive KLA578-1 for injection 120mg over 5 consecutive days.
干预措施: KLA578-1 for injection (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: Up to day 13
次要结局
- PK parameter Cmax(single dose：up to Day 6 ; multiple doses: up to Day 8)
- PK parameter Tmax(single dose：up to Day 6 ; multiple doses: up to Day 8)
- PK parameter Cmin,ss(multiple doses: up to Day 1)
- PK parameter AUC0-t(single dose：up to Day 6 ; multiple doses: up to Day 8)
- PK parameter AUC0-∞(single dose：up to Day 6 ; multiple doses: up to Day 8)
- PK parameter AUCtau,ss(multiple doses: up to Day 1)
- PK parameter t1/2(single dose：up to Day 6 ; multiple doses: up to Day 8)