A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, First-in-human, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Safety and Tolerability Assessment
研究概览
简要总结
A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects.
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
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects aged 19 - 45 years at the time of screening visit procedure.
- •The subject weighs in the range of 50.0 - 90.0 kg and has a body mass index (BMI) in the range 18-27 kg/m
- •Sufficient ability to understand the study after being informed about the study and provide written informed consent.
- •Based on physical examination, vital sign, 12-lead ECG and laboratory test etc. and in the opinion of the investigator, the subject is suitable for the study.
排除标准
- •A subject with clinically significant hepatobiliary, renal, neurologic, respiratory, endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a history
- •A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin etc.)
- •A subject who has hypersensitivity to the drugs of the drugs containing the same class, or other drugs, or a history of clinically significant hypersensitivity
- •A subject who has ventricular tachycardia, ventricular tachycardia, ventricular flutter or confirmed other ventricular flutter and QTc interval: > 450 ms or the other clinically significant medical findings
- •A subject with the following results in the screening test:
- •Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5
- •Blood CPK > Normal range upper × 1.5
- •eGFR (CKD-EPI equation) < 60 mL/min/1.73 m2
- •Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
- •A subject with the following results in the screening test:
- •systolic blood pressure < 80 mmHg or > 140 mmHg
- •diastolic blood pressure < 50 mmHg or > 90 mmHg
- •A subject with a history of drug abuse or positive urine screening test for drug abuse
- •A subject who administered any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or any over-the-counter drug (OTC drug) or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator).
- •A subject who participated in other clinical trial and administered investigational drug within 6 months prior to the expected date of the first dose
- •A subject who donated whole blood within 2 months or the component blood within 1 month prior to the expected date of the first dose, or received blood transfusion within 1 month prior to the expected date of the first dose
- •Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening day.
- •A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking from 3 days before the expected date of the first dose until the last discharge
- •A male subject who has plan to have a baby or to donate sperm. A female subject who is pregnant or lactating or has plan to lactate within 3 months after administration of IP
- •A subject who is intending to become pregnant during this study or with inability to use a medically acceptable contraception method(ex. sterilization operation, intrauterine device etc. for Subject or subject's partner
- •※ medically acceptable contraception method
- •Use of intrauterine device which is proven pregnancy failure rates in spouses (or partners).
- •Use combined blocking contraceptives (for male or female) and antiseptic drugs
- •Subject or partner's operation(vasectomized, bilateral tubal occlusion, hysterectomy)
- •Subject who is considered inadequate to participation in the study due to other reason under investigator's discretion
研究组 & 干预措施
C1K 600mg or placebo
Subcutaneous Administration C1K 600mg or placebo single or multi dose
干预措施: Placebo with the same volume of C1K 600mg (Drug)
C1K 900mg or placebo
Subcutaneous Administration C1K 900mg or placebo single or multi dose
干预措施: C1K 900mg (Drug)
C1K 150mg
Subcutaneous Administration C1K 150mg single or multi dose
干预措施: C1K 150mg (Drug)
C1K 300mg or placebo
Subcutaneous Administration C1K 300mg or placebo single or multi dose
干预措施: C1K 300mg (Drug)
C1K 300mg or placebo
Subcutaneous Administration C1K 300mg or placebo single or multi dose
干预措施: Placebo with the same volume of C1K 300mg (Drug)
C1K 600mg or placebo
Subcutaneous Administration C1K 600mg or placebo single or multi dose
干预措施: C1K 600mg (Drug)
C1K 900mg or placebo
Subcutaneous Administration C1K 900mg or placebo single or multi dose
干预措施: Placebo with the same volume of C1K 900mg (Drug)
C1K 1200mg or placebo
Subcutaneous Administration C1K 1200mg or placebo single or multi dose
干预措施: C1K 1200mg (Drug)
C1K 1200mg or placebo
Subcutaneous Administration C1K 1200mg or placebo single or multi dose
干预措施: Placebo with the same volume of C1K 1200mg (Drug)
结局指标
主要结局
Safety and Tolerability Assessment
时间窗: Day -1 to Day 23
Percentage of occurrences observed Adverse Event in each group.
Safety and Tolerability Assessment by Value Changes in Physical Examination
时间窗: Day -1 to Day 23
physical examination changes from baseline.
Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram
时间窗: Day -1 to Day 23
12-Lead Electrocardiogram(ECG) changes from baseline.
Pharmacokinetic Assessment by Minimum concentration of C1K in plasma
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Minimum concentration of C1K in plasma(Cmin,ss)
Safety and Tolerability Assessment by Value Changes in Laboratory Test
时间窗: Day -1 to Day 23
laboratory test changes from baseline assessed through hematology, blood biochemistry, urinalysis and blood coagulation.
Safety and Tolerability Assessment by Response Change of Injection site.
时间窗: Day 1 to Day 23
Percentage of occurrences observed response change of injection site.
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of C1K from Time Zero to the Last Measurable Point
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Area under the plasma C1K concentration-time curve from 0 to last(AUClast)
Pharmacokinetic Assessment by Apparent Clearance of C1K
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Apparent Clearance(CL/F)
Safety and Tolerability Assessment by Value Changes in Vital Signs
时间窗: Day -1 to Day 23
Vital Signs including blood pressure and heart rate changes from baseline.
Pharmacokinetic Assessment by Area under the plasma C1K concentration-time curve from 0 to infinity
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Area under the plasma C1K concentration-time curve from 0 to last(AUCinf)
Pharmacokinetic Assessment by Accumulation Ratio of C1K
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Accumulation Ratio(Rac)
Pharmacokinetic Assessment by The time of peak concentration of C1K
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
The time of peak concentration(Tmax)
Pharmacokinetic Assessment by Peak to trough fluctuation ratio
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Peak to trough fluctuation ratio(PTF)
Pharmacokinetic Assessment by Maximum concentration of C1K in plasma
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Maximum concentration of C1K in plasma (Cmax)
Pharmacokinetic Assessment by Elimination half-life of C1K
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Elimination half-life(t1/2)
Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Apparent Volume of Distribution After extravascular administration(Vz/F)
Pharmacokinetic Assessment by Average concentration of C1K in plasma
时间窗: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Average concentration of C1K in plasma(Cav)
次要结局
未报告次要终点