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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose 1 | Experimental | 0.0025%(0.025 mg/mL) |
|
| Single Dose 2 | Experimental | 0.005%（于0.05 mg/mL） |
|
| Single Dose 3 | Experimental | 0.01%（0.1 mg/mL） |
|
| Single Dose 4 | Experimental | 0.02%（0.2 mg/mL） |
|
| Multiple Dose 1 | Experimental | 0.05%（0.05 mg/mL） |
|
| Multiple Dose 2 | Experimental | 0.01%（0.01 mg/mL） |
|
| Multiple Dose 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CU-40101 | Drug | CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02% |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Zhejiang | Hangzhou | 310052 | China |
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0.02%（0.02 mg/mL） |
|
| Placebo | Placebo Comparator | Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400 |
|
| 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 |