AGA
Conditions
Brief summary
1. To evaluate the safety and tolerability of CU-40101 liniment as a single and multiple topical application in adult male androgenic alopecia subjects； 2. 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.
Interventions
DRUGCU-40101
CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%
Sponsors
Cutia Therapeutics（Wuxi）Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has provided written informaed consent. 2. Subject is male, 18-55 years old. 3. Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, Ⅲ to Ⅶ on the Modified Norwood-Hamilton Scale. 4. Subject has a body mass index(BMI) of 19 to 28 kg/㎡ inclusive and body weight not less than 50kg. 5. 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 6. 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
1. Allergic to the study drug or any ingredient in the study drug 2. Skin damage or abnormality at the administration site may affect drug absorption or evaluation, such as dermatitis, scar, tattoo, sunburn, etc 3. 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 4. 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 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE and SAE | 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. |
| Vital signs | Single dose 29 days; Multiple dose 39 days | Descriptive statistics summarizing changes in heart rate will be compared between baseline levels at each predetermined point in time. |
| 12-lead ECG | 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. |
| Laboratory inspection | 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. |
| Assessment of topical skin tolerance | Single dose 29 days; Multiple dose 39 days | The number of erythema, burning/tingling, dryness, pruritus, desquamation of skin and hyperpigmentation after dosing. |
Countries
China
Outcome results
None listed