CU-40101-101 Following a Fixed-volume Topical Single Administration in Healthy Male Subjects With Androgenetic Alopecia

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: Male

Summary

1. To evaluate the safety and tolerability of TDM-105795 administered topically in healthy male subjects with androgenetic alopecia(AGA ).

2. To evaluate the pharmacokinetics (PK)/Pharmacodynamics (PD) of TDM-105795 following administration of a single dose.

Fixed volume, randomized, double-blinded, vehicle-controlled, parallel group, dose escalation comparison

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd

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