Clinical trial NCT05380427: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AGA
Lead sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: AE and SAE
timeFrame: Single dose 29 days; Multiple dose 39 days
measure: Vital signs
timeFrame: Single dose 29 days; Multiple dose 39 days
measure: Vital signs
timeFrame: Single dose 29 days; Multiple dose 39 days
measure: Vital signs
timeFrame: Single dose 29 days; Multiple dose 39 days
measure: 12-lead ECG
timeFrame: Single dose 29 days; Multiple dose 39 days
measure: Laboratory inspection
timeFrame: Single dose 29 days; Multiple dose 39 days
measure: Vital signs
timeFrame: Single dose 29 days; Multiple dose 39 days
measure: Assessment of topical skin tolerance
timeFrame: Single dose 29 days; Multiple dose 39 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Hangzhou
Study officials:
References: