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

Cutia Therapeutics

Status and phase: Completed; Phase 1

Conditions: AGA

Treatments: Drug: CU-40101

Study type: Interventional

Funder types: Industry

Identifiers

NCT05380427

CU-40101-101

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 8 patient groups, including a placebo group

Single Dose 1

Experimental group

Description:

0.0025%(0.025 mg/mL)

Treatment:

Drug: CU-40101

Single Dose 2

Experimental group

Description:

0.005%（于0.05 mg/mL）

Treatment:

Drug: CU-40101

Single Dose 3

Experimental group

Description:

0.01%（0.1 mg/mL）

Treatment:

Drug: CU-40101

Single Dose 4

Experimental group

Description:

0.02%（0.2 mg/mL）

Treatment:

Drug: CU-40101

Multiple Dose 1

Experimental group

Description:

0.05%（0.05 mg/mL）

Treatment:

Drug: CU-40101

Multiple Dose 2

Experimental group

Description:

0.01%（0.01 mg/mL）

Treatment:

Drug: CU-40101

Multiple Dose 3

Experimental group

Description:

0.02%（0.02 mg/mL）

Treatment:

Drug: CU-40101

Placebo

Placebo Comparator group

Description:

Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400

Treatment:

Drug: CU-40101