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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, Hangzhou, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Single dose 29 days; Multiple dose 39 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vital signs
Descriptive statistics summarizing changes in respiration will be compared between baseline levels at each predetermined point in time.
Time frame: 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.
Time frame: Single dose 29 days; Multiple dose 39 days