A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KLA318-2 Nanocrystal Injection in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 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,tolerability and pharmacokinetics properties of KLA318-2 Nanocrystal Injection after a single intravenous injection in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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 participants (Age: 18~45 years);
- •Body Weight: Male≥50.0kg, Female≥45.0kg; 18.5 ≤BMI≤ 28.0;
- •Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
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 drug interactions with celecoxib within 30 days;
- •History of any clinical study within 3 months;
- •History of any vaccine within 1 month;
- •History of any drug abuse, or positive drugs of abuse test result;
- •Subjects with difficult venous blood collection/intolerance to venipuncture, or with a history of needle phobia/blood phobia;
- •Massive blood loss (> 200 mL) in the past 3 months;
- •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, or positive alcohol test;
- •Heavy caffeine intake;
- •History of grapefruit, xanthine-rich foods intake within 7 days;
- •Female participants are pregnant or lactating;
- •History of unprotected sex within 2 weeks.
研究组 & 干预措施
KLA318-2 Nanocrystal Injection 60mg
12 participants receive KLA318-2 60mg
干预措施: KLA318-2 Nanocrystal Injection (Drug)
KLA318-2 Nanocrystal Injection 120mg
Period 1, 6 participants receive KLA318-2 120mg → 6 participants receive Celebrex Capsule 200mg; Period 2, 6 participants receive Celebrex Capsule 200mg → 6 participants receive KLA318-2 120mg
干预措施: KLA318-2 Nanocrystal Injection (Drug)
KLA318-2 Nanocrystal Injection 180mg
Period 1, 6 participants receive KLA318-2 180mg → 6 participants receive Celebrex Capsules 400mg; Period 2, 6 participants receive Celebrex Capsules 400mg → 6 participants receive KLA318-2 180mg
干预措施: KLA318-2 Nanocrystal Injection (Drug)
KLA318-2 Nanocrystal Injection 240mg
12 participants receive KLA318-2 240mg
干预措施: KLA318-2 Nanocrystal Injection (Drug)
KLA318-2 Nanocrystal Injection 120mg
Period 1, 6 participants receive KLA318-2 120mg → 6 participants receive Celebrex Capsule 200mg; Period 2, 6 participants receive Celebrex Capsule 200mg → 6 participants receive KLA318-2 120mg
干预措施: Celebrex Capsule (Drug)
KLA318-2 Nanocrystal Injection 180mg
Period 1, 6 participants receive KLA318-2 180mg → 6 participants receive Celebrex Capsules 400mg; Period 2, 6 participants receive Celebrex Capsules 400mg → 6 participants receive KLA318-2 180mg
干预措施: Celebrex Capsule (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: UP to Day 14
次要结局
- PK parameter Cmax(UP to Day 3)
- PK parameter Tmax(UP to Day 3)
- PK parameter AUC0-t(UP to Day 3)
- PK parameter AUC0-∞(UP to Day 3)
- PK parameter t1/2(UP to Day 3)