NCT05587699已完成1 期
A Randomized, Open-label, Multiple-dose and Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A in Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- AUC0 to Day 271
研究概览
简要总结
A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male 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
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Those who aged between 19 to 50
- •(Part 1) Those who are diagnosed to androgenic alopecia and meet criteria BASP grade
- •M2~M3 or C2~C3 grade with V1~V3 or F1~F3
- •M1 or C1 grade with V2~V3 or F2~F3
- •(Part 1) Those who consent to the condition write below
- •Scalp tattoo & to cutting hair for hair evaluation
- •Maintaining hair style & color
- •(Part 2) Those who are healthy male (Regardless of alopecia)
- •Those who has body weight ≥ 55kg
- •Those who has calculated body mass index(BMI) of 18.5 ≤ ~ < 27.0 kg/m2
- •Body Mass Index, kg/m2= Body weight(kg)/[Height(m)2]
- •Those who consent to proper contraception and do not donate sperm until 6 months after the last administration of investigational product
- •Those who understanding the detailed description of this clinical trial and voluntarily decide to participate
排除标准
- •Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Hemato-oncology disorder, Cardiovascular disorder or Psychical disorder
- •(Part 1) Those who meets the conditions write below
- •alopecia areata, telogen alopecia
- •Those who has psoriasis or folliculitis or scar on hair evaluation area
- •Those who has experience of platelet-enriched plasma treatment to scarp within 24 weeks before the first administration of investigational product
- •Those who has experience of light or laser treatment to scarp within 12 weeks before the first administration of investigational product
- •Those who has experience of prophylaxis or medication of hair loss within 14 days before the first administration of investigational product
- •Those who take dutasteride or finasteride within 6 month before the first administration of investigational product
- •Those who has hypersensitivity to dutasteride or other 5-alpha reductase related inhibitors.
- •(Part 1) Those who has hypersensitivity to tatto ink.
- •Those who have the screening(D-28~D-2) test results write below
- •AST, ALT > 1.5 times higher than upper normal level
- •Total bilirubin > 1.5 times higher than upper normal level
- •eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
- •"Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR
- •Under 5 min resting condition, systolic blood pressure >150 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
- •Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
- •Those who receive following drugs, which may affect results of clinical trial and safety Ethical-the-counter (ETC) drugs and herbal medicines within 14 days before the first administration and Over-the-counter (OTC) drugs, health foods and vitamin preparations within 7 days before the first administration of the investigational product.
- •Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 30 days before the first administration of investigational product.
- •Those who exceeding smoke & alcohol consumption criteria.
- •Smoke: > 10 cigarettes/day
- •Caffeine: > 5 cups/day
- •Alcohol > 210 g/week
- •Those who take grapefruit within 7 days before the first administration of investigational product.
- •Those who receive investigational product by participating in other clinical trial within 180 days before the first administration of investigational product.
- •Those who donate whole blood within 60 days or apheresis within 30 days before the first administration of investigational product.
- •Those who receive transfusion within 30 days before the first administration of investigational product.
- •Those who are deemed inappropriate to participate in clinical trial by investigators.
研究组 & 干预措施
Group - A1(Part 1)
Experimental
CKD-843 A 45mg
干预措施: CKD-843 A 45mg(Multiple dose) (Drug)
Group - A2(Part 2)
Experimental
CKD-843 A 45mg
干预措施: CKD-843 A 45mg (Drug)
Group - B1(Part 1)
Experimental
CKD-843 A 55mg
干预措施: CKD-843 A 55mg(Multiple dose) (Drug)
Group - B2(Part 2)
Experimental
CKD-843 A 55mg
干预措施: CKD-843 A 55mg (Drug)
Group - R(Part 1)
Active Comparator
CKD-843-R
干预措施: CKD-843-R (Drug)
结局指标
主要结局
AUC0 to Day 271
时间窗: Pre-dose(Day 1 - 0 hour), Day 1 - 4 hours, Day 2, Day 8, Day 15, Day 30, Day 46, Day 61, Day 91, Day 91 - 4 hours, Day 92, Day 98, Day 105, Day 121, Day 136, Day 151, Day 181, Day 181 4 hours, Day 182, Day 188, Day 195, Day 211, Day 226, Day 241, Day 271
Area under the concentration-time curve from time Day 1(Pre-dose) to Day 271
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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