A Phase I, Open-label Study to Assess the Pharmacokinetics of KY1005 After Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the concentration time curve from time 0 to last observation (AUC 0-t)
研究概览
简要总结
Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration, with i.v. KY1005 as a reference treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18-45 years at screening
- •Body weight 60-120 kg
- •Body mass index (BMI) in the range 18.0-30.0 kg/m^2 (inclusive)
- •Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs and laboratory tests of blood and urine
排除标准
- •Clinically relevant abnormal findings at the screening assessment; acute or chronic illness; clinically relevant abnormal medical history or concurrent medical condition; positive tests for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)
- •Drug or alcohol abuse
- •Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
- •Participation in other clinical trials of unlicensed medicines within the 3 months or 5 half-lives, whichever is longer, before admission to this study
- •Loss of more than 400 mL blood, within the previous 3 months
研究组 & 干预措施
Group 1
Single dose of KY1005 by i.v. infusion
干预措施: KY1005 (Drug)
Group 2
Single lower dose KY1005 by s.c. injection
干预措施: KY1005 (Drug)
Group 3
Single higher dose KY1005 by s.c. injections
干预措施: KY1005 (Drug)
结局指标
主要结局
Area under the concentration time curve from time 0 to last observation (AUC 0-t)
时间窗: Baseline to day 92
Area under the concentration time curve from time 0 to infinity (AUC0-inf)
时间窗: Baseline to day 92
Systemic clearance after i.v. infusion (CL)
时间窗: Baseline to day 92
Steady-state volume of distribution after i.v. infusion (Vss)
时间窗: Baseline to day 92
Half-life t½
时间窗: Baseline to day 92
Volume of distribution during the terminal phase after i.v. infusion (Vz)
时间窗: Baseline to day 92
Apparent volume of distribution after s.c. injection (Vz/F)
时间窗: Baseline to day 92
Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration
时间窗: Baseline to day 92
Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration
时间窗: Baseline to day 92
Apparent systemic clearance after s.c. injection (CL/F)
时间窗: Baseline to day 92
Maximum observed concentration (Cmax) after infusion
时间窗: Baseline to day 92
Time at which Cmax is observed after infusion (tmax)
时间窗: Baseline to day 92
Weight-normalised Vss and Vz
时间窗: Baseline to day 92
Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion
时间窗: Baseline to day 92
次要结局
- Changes in heart rate bpm (as a measure of safety and tolerability)(Baseline to day 92)
- Changes in tympanic temperature °C (as a measure of safety and tolerability)(Baseline to day 92)
- Occurrence of local injection site reactions(Baseline to day 92)
- Changes in blood pressure mmHg (as a measure of safety and tolerability)(Baseline to day 92)
- Occurrence of TESAE(Baseline to day 92)
- Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)(Baseline to day 92)
- Occurrence of TEAE(Baseline to day 92)
- Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)(Baseline to day 92)