A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of CU-40101 Liniment in Single and Multiple Doses in Adult Male Androgenic Alopecia Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- AE and SAE
研究概览
简要总结
- To evaluate the safety and tolerability of CU-40101 liniment as a single and multiple topical application in adult male androgenic alopecia subjects；
- To evaluate the pharmacokinetic (PK) characteristics of CU-40101 liniment administered as a single and multiple topical skin application in adult male subjects with androgenic alopecia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has provided written informaed consent.
- •Subject is male, 18-55 years old.
- •Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, Ⅲ to Ⅶ on the Modified Norwood-Hamilton Scale.
- •Subject has a body mass index(BMI) of 19 to 28 kg/㎡ inclusive and body weight not less than 50kg.
- •According to the history, physical examination, vital signs, 12-lead electrocardiogram and laboratory examination results, the patient was in good health with no clinically significant abnormalities
- •Subjects (including partners) are willing to take effective contraceptive measures voluntarily within 3 months from signing the informed consent to the last dose.
排除标准
- •Allergic to the study drug or any ingredient in the study drug
- •Skin damage or abnormality at the administration site may affect drug absorption or evaluation, such as dermatitis, scar, tattoo, sunburn, etc
- •Subjects who currently have thyroid disease (including hyperthyroidism, hypothyroidism, etc.) or are currently receiving thyroxine replacement therapy. Thyroid function abnormalities on blood tests at the screening stage or thyroid ultrasound that the investigator judged to be clinically significant must be excluded
- •Any surgical procedures performed within 3 months prior to screening, or planned during the study and within 1 month after the subject completed all study visits
- •A history of clinically significant heart, liver, neurological, respiratory, hematological, digestive, immune, renal, or psychiatric disorders that the investigator believes may confound study results or affect drug absorption, distribution, metabolism, and excretion or place the subject at inappropriate risk
研究组 & 干预措施
Single Dose 2
0.005%（于 0.05 mg/mL）
干预措施: CU-40101 (Drug)
Multiple Dose 2
0.01%（0.01 mg/mL）
干预措施: CU-40101 (Drug)
Single Dose 1
0.0025%(0.025 mg/mL)
干预措施: CU-40101 (Drug)
Single Dose 3
0.01%（0.1 mg/mL）
干预措施: CU-40101 (Drug)
Single Dose 4
0.02%（0.2 mg/mL）
干预措施: CU-40101 (Drug)
Multiple Dose 1
0.05%（0.05 mg/mL）
干预措施: CU-40101 (Drug)
Multiple Dose 3
0.02%（0.02 mg/mL）
干预措施: CU-40101 (Drug)
Placebo
Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400
干预措施: CU-40101 (Drug)
结局指标
主要结局
AE and SAE
时间窗: Single dose 29 days; Multiple dose 39 days
TEAE and SAE will be summarized by dose grouping based on systematic organ Classification (SOC), preferred term (PT) and severity, as well as their relationship to the study drug. Subjects who reported multiple adverse events within the same SOC and PT could only be counted once, according to the highest severity level.
12-lead ECG
时间窗: Single dose 29 days; Multiple dose 39 days
The number of results of heart rate, QT, QTcF and PR interval will be collected. Descriptive statistics summarizing changes of parameters above will be compared between baseline levels at each predetermined point in time.
Vital signs
时间窗: Single dose 29 days; Multiple dose 39 days
Descriptive statistics summarizing changes in respiration will be compared between baseline levels at each predetermined point in time.
Assessment of topical skin tolerance
时间窗: Single dose 29 days; Multiple dose 39 days
The number of erythema, burning/tingling, dryness, pruritus, desquamation of skin and hyperpigmentation after dosing.
Laboratory inspection
时间窗: Single dose 29 days; Multiple dose 39 days
The number of results of blood routine examination, Blood Biochemical and routine urine examination will be collected Descriptive statistics summarizing changes of parameters above will be compared with baseline levels at each predetermined point in time.
次要结局
未报告次要终点