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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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AGA

Intervention / Treatment
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* Drug: CU-40101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose 1<br>0.0025%(0.025 mg/mL) | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|
| Experimental: Single Dose 2<br>0.005%（于0.05 mg/mL） | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|
| Experimental: Single Dose 3<br>0.01%（0.1 mg/mL） | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|
| Experimental: Single Dose 4<br>0.02%（0.2 mg/mL） | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|
| Experimental: Multiple Dose 1<br>0.05%（0.05 mg/mL） | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|
| Experimental: Multiple Dose 2<br>0.01%（0.01 mg/mL） | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|
| Experimental: Multiple Dose 3<br>0.02%（0.02 mg/mL） | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|
| Placebo Comparator: Placebo<br>Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400 | Drug: CU-40101<br>* CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE and SAE | 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. | Single dose 29 days; Multiple dose 39 days | 
| Vital signs | Descriptive statistics summarizing changes in heart rate will be compared between baseline levels at each predetermined point in time. | Single dose 29 days; Multiple dose 39 days | 
| Vital signs | Descriptive statistics summarizing changes in sitting blood pressure (systolic and diastolic) will be compared between baseline levels at each predetermined point in time. | Single dose 29 days; Multiple dose 39 days | 
| Vital signs | Descriptive statistics summarizing changes in body temperature will be compared between baseline levels at each predetermined point in time. | Single dose 29 days; Multiple dose 39 days | 
| 12-lead ECG | 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. | Single dose 29 days; Multiple dose 39 days | 
| Laboratory inspection | 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. | Single dose 29 days; Multiple dose 39 days | 
| Vital signs | Descriptive statistics summarizing changes in respiration will be compared between baseline levels at each predetermined point in time. | Single dose 29 days; Multiple dose 39 days | 
| Assessment of topical skin tolerance | The number of erythema, burning/tingling, dryness, pruritus, desquamation of skin and hyperpigmentation after dosing. | Single dose 29 days; Multiple dose 39 days |