Status:
COMPLETED
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
Lead Sponsor:
Cutia Therapeutics（Wuxi）Co.,Ltd
Conditions:
AGA
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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) charact...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05380427
Start Date
August 15 2022
End Date
February 22 2024
Last Update
September 19 2024
Active Locations (1)
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1
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, Hangzhou, China, 310052