NCT02309008已完成1 期
A Randomized, Double-blind, Placebo-controlled Multiple Dosing Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream After Transdermal Administration in Healthy Volunteers
适应症
干预措施
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
- Safety/Tolerability (adverse events, abnormal vital signs, ECG test, clinical lab tests, Numerical pain recording scale)
研究概览
简要总结
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of PAC-14028 cream after transdermal administration in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men aged 19 to 65 years at the time of screening
- •Whose weight is 50 kg or more, but less than 90 kg, and whose body mass index (BMI) is 18.0 kg/m^2 or more but less than 27 kg/m^2
- •BMI (kg/m^2) = weight(kg) /{height(m)}^2
- •Who doesn't have skin disease, skin damage (including tatoos or scars), or excessive hair in application area which can affect drug absorption
- •Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception
排除标准
- •Who has clinically significant medical history or diseases involving liver, kidney, neurological system, respiratory system, endocrine system, urinary system, cardiovascular system,skin, psychical disorders or blood tumor
- •Who has a history of hypersensitivity or allergies to any drug (aspirin, antibiotics, etc)
- •Who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration, or who has taken any over-the-counter (OTC) drugs or vitamins within 1 week before the study drug initiation (Investigators will determine his eligibility by considering the effect of the drug on his safety or pharmacokinetic results in case other inclusion/exclusion criteria is satisfied.)
- •Who has drug abuse history or positive result at urine screening tests (cannabinoid, opioid, amphetamine, cocaine, barbiturate, benzodiazepine)
- •Who has smoked within 3 months before study drug administration (Smoker who has stopped smoking for more than 3 months before study drug administration is eligible to participate)
- •Who has confirmed positive at serological tests (HBs antigen, HCV antibody and HIV antibody)
- •Who consistently consumes alcohol
- •Who has participated in other clinical study within 8 weeks before study drug administration (however, the last dosing day is considered as the end of clinical study.)
- •Who has had bleeding or blood collection and donation over 400 mL within 8 weeks before study drug administration
- •Who donated whole blood within 2 months before study drug administration, who donated via plasmapheresis/plateletpheresis within 1 month before study drug administration, or who received a blood transfusion within 1 month before study drug administration
- •Whose vital sign measured at sitting position after resting at least 3 minutes is as following
- •Low blood pressure (Systolic pressure: less than 90 mmHg, Diastolic pressure: less than 60 mmHg)
- •High blood pressure (Systolic pressure: higher than 150 mmHg, Diastolic pressure: higher than 100 mmHg)
- •Who is determined ineligible for study participation by investigators for any reason including clinical lab test and ECG results.
研究组 & 干预措施
placebo
Placebo Comparator
vehicle cream, dermal administration, multiple dosing
干预措施: Vehicle (Other)
drug
Experimental
PAC-14028 cream, dermal administration, multiple dosing, dose escalation
干预措施: PAC-14028 (Drug)
结局指标
主要结局
Safety/Tolerability (adverse events, abnormal vital signs, ECG test, clinical lab tests, Numerical pain recording scale)
时间窗: Day 1~9, at specified time for each tests
AE incidence pattern, abnormal findings in vital sign, ECG test, and clinical lab tests, Numerical pain recording scale
次要结局
- Pharmacokinetics (Concentration of PAC-14028 in Blood; Cmax, AUC)(Day 1: 0 ~ 16h ; Day 2~8: 0h ; Day 9: 0 ~ 96h)
研究者
研究点 (1)
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