A Dose Blocked-Randomized, Single-Blind, Placebo-Controlled and Dose-Escalation Phase I Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011 After Intramuscular Administration in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of subjects with treatment-emergent adverse event or adverse drug reaction
研究概览
简要总结
This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •A male whose age is between 19 and 55 years of age
- •A person whose body mass index is between 18.5 and 27 kg/m2 at screening
- •A person who has the ability and willingness to participate in the clinical trial
- •A person who voluntarily agrees with the clinical trial after hearing and fully understanding the detailed explanation of this clinical trial
排除标准
- •A person who has a clinically significant disease or history of liver, kidney, neuropsychiatry, immune system, respiratory system, endocrine system, hematology*oncology system, cardiovascular system, etc.(In the case of liver disease items, it includes subjects who have hepatitis virus)
- •A person who has clinical history of hypersensitivity reactions to the major components or constituents of investigational product or other clinically significant hypersensitivity reactions to drugs or foods, or those with allergic diseases requiring treatment
- •A person with infectious disease or severe trauma within 21 days of the randomization date
- •A person whose serum AST, ALT or γ-GT levels exceed 1.5 times the upper limit of the reference range at screening
- •A person whose QTcF on the electrocardiogram exceeds 430 msec or who has a clinically significant abnormal rhythm at screening
- •A person with a glomerular filtration rate less than 60 mL/min/1.73 m2 calculated from serum creatinine at screening
- •A person with a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 60 mmHg, or greater than 100 mmHg at screening
- •A person with thrombocytopenia or coagulopathy which should not be given intramuscular injection
- •A person whose weekly average drinking amount exceeds 140g of alcohol per week
- •A person whose daily average smoking amount exceeds 10 per day
- •A person who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the investigational product within 14 days of the injection
- •A person who has the history of substance abuse or positive urine screening test
- •A person who have received a investigational product or a bioequivalence study drug within at least 90 days prior to the randomization
- •A person who donated whole blood within 60 days before the randomization, or donated components of blood within 30 days
- •A person who dose not have a medically approved contraceptive during the trial and has a plan to provide sperm
- •A person who has clinically significant abnormalities from clinical laboratory test
- •A person who is deemed ineligible for clinical trials by the investigator
研究组 & 干预措施
KMRC011 5μg or Placebo
Cohort 1
干预措施: KMRC011 5μg or Placebo (Drug)
KMRC011 10μg or Placebo
Cohort 2
干预措施: KMRC011 10μg or Placebo (Drug)
KMRC011 15μg or Placebo
Cohort 3
干预措施: KMRC011 15μg or Placebo (Drug)
KMRC011 20μg or Placebo
Cohort 4
干预措施: KMRC011 20μg or Placebo (Drug)
KMRC011 25μg or Placebo
Cohort 5
干预措施: KMRC011 25μg or Placebo (Drug)
结局指标
主要结局
Number of subjects with treatment-emergent adverse event or adverse drug reaction
时间窗: Up to 7±1 days after injection
Number of subjects with clinically significant changes in hematology test result after injection
时间窗: Up to 7±1 days after injection
Number of subjects with clinically significant changes in blood chemistry test result after injection
时间窗: Up to 7±1 days after injection
Number of subjects with clinically significant changes in urinalysis test result after injection
时间窗: Up to 7±1 days after injection
Number of subjects with clinically significant changes in blood coagulation test result after injection
时间窗: Up to 7±1 days after injection
Number of subjects with clinically significant changes in ECG (Electrocardiogram) after injection
时间窗: Up to 7±1 days after injection
Number of subjects with clinically significant changes in vital sign after injection
时间窗: Up to 7±1 days after injection
Number of subjects with clinically significant physical abnormality after injection
时间窗: Up to 7±1 days after injection
Maximum serum concentration (Cmax) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Time of the maximum serum concentration (Tmax) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Area under the serum concentration versus time curve, from time 0 to the last measurable concentration (AUC0-t) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Percentage of AUCinf due to extrapolation from time of last measurable concentration to infinity (AUCextra) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Apparent clearance (CL/F) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Apparent volume of distribution (Vd/F) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Terminal half-life (t1/2) of KMRC011
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 hours post-dose
Maximum effect over the time span specified (Emax) of G-CSF
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Maximum effect over the time span specified (Emax) of IL-6
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of G-CSF
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
Area under the effect versus time curve, from time 0 to the last measurable concentration (AUEC0-t) of IL-6
时间窗: Pre-dose(0 hours) and 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48 hours post-dose
次要结局
- Maximum Tolerated Dose (MTD) of KMRC011(Until the study completion, approximately up to 35 weeks)