A Randomized, Single-blind, Placebo-controlled, Single/Multiple Dose, Dose Escalation, Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of CKR-051 After Transdermal Administration in Healthy Male Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- SAD : Safety and tolerability (Numeric pain rating scale)
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of CKR-051 in healthy participants.
This study aiming to develop an agent for skin regeneration; potential treatments include acute and chronic wounds (c.f. Diabetic foot ulcers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 19 years to 60 years (Healthy male)
- •Body weight 55 kg to 90 kg and BMI 19 kg/m^2 to 29 kg/m^2
- •Do not have skin disease or skin damage (including scars or tattoos) or excessive body hair at the drug application site
- •Must be suitable by a subject by medical evaluation including physical examination, laboratory tests, questionnaire, etc.
排除标准
- •History of clinically significant hepatobiliary, kidney, nervous, immune, respiratory, digestive, endocrine, blood/tumor, cardiovascular, urinary, mental, dermatological diseases, etc.
- •With tattoos, dermatitis, pigmentation, dermatitis, etc., or damaged skin at the site of clinical trial drug administration
- •Drug hypersensitivity reactions and history (Aspirin, antibiotics, etc.)
- •History of drug abuse and positive urine screening test
- •eGFR (CKD-EPI) < 60 mL/min/1.73m^2
- •AST/ALT > 1.5 UNL
- •Alcohol > 21 units/week
- •Eating food containing a grapefruit
- •Caffeine > 5 units/day
研究组 & 干预措施
CKR-051 SAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.
干预措施: CKR-051 Dose 1 (Drug)
CKR-051 SAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.
干预措施: CKR-051 Dose 2 (Drug)
CKR-051 SAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.
干预措施: CKR-051 Dose 3 (Drug)
CKR-051 SAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.
干预措施: CKR-051 Dose 4 (Drug)
CKR-051 SAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 1 day.
干预措施: Placebo (Drug)
CKR-051 MAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.
干预措施: CKR-051 Dose 2 (Drug)
CKR-051 MAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.
干预措施: CKR-051 Dose 3 (Drug)
CKR-051 MAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.
干预措施: CKR-051 Dose 4 (Drug)
CKR-051 MAD
Participants will be administrated a single dermal dose of CKR-051 at various ascending dose levels or matching placebo for 21 day.
干预措施: Placebo (Drug)
结局指标
主要结局
SAD : Safety and tolerability (Numeric pain rating scale)
时间窗: Day 1
Score 0 to 7. Higher scores mean a worse outcome. 0 (No irritation); 1 (Minimal erythema); 2 (Erythema and papule); 3 (Palpable erythema and papule); 4 (Palpable edema); 5 (Edema, erythema and papule); 6 (Vesicular eruption); 7 (Spreading beyond the test area).
MAD : Safety and tolerability (Numeric pain rating scale)
时间窗: Day 1 to Day 21 (Everyday)
Score 0 to 7. Higher scores mean a worse outcome. 0 (No irritation); 1 (Minimal erythema); 2 (Erythema and papule); 3 (Palpable erythema and papule); 4 (Palpable edema); 5 (Edema, erythema and papule); 6 (Vesicular eruption); 7 (Spreading beyond the test area).
次要结局
- SAD : Pharmacokinetics (Cmax)(Day 1)
- SAD : Pharmacokinetics (AUC)(Day 1)
- SAD : Pharmacokinetics (Tmax)(Day 1)
- SAD : Pharmacokinetics (t1/2)(Day 1)
- SAD : Pharmacokinetics (Vz/F)(Day 1)
- SAD : Pharmacokinetics (CL/F)(Day 1)
- MAD : Pharmacokinetics (Cmax)(Day 1, 7, 14, 18, 19, 20 and 21)
- MAD : Pharmacokinetics (AUC)(Day 1, 7, 14, 18, 19, 20 and 21)
- MAD : Pharmacokinetics (Tmax)(Day 1, 7, 14, 18, 19, 20 and 21)
- MAD : Pharmacokinetics (t1/2)(Day 1, 7, 14, 18, 19, 20 and 21)
- MAD : Pharmacokinetics (Vz/F)(Day 1, 7, 14, 18, 19, 20 and 21)
- MAD : Pharmacokinetics (CL/F)(Day 1, 7, 14, 18, 19, 20 and 21)