Phase II Study Evaluating the Efficacy and Safety of KX-826

Based on the results of the Phase I studies of KX-826 in Androgenetic Alopecia and the pre-clinical PD studies, the investigational product will be administered at 2.5 mg BID (0.25%), 5 mg QD (0.5%), and 5 mg BID (0.5%) in treatment groups A, B, and C, respectively, with 30 patients/group; a total of 30 patients will be administered in the placebo QD group (10) and placebo BID group (20). The investigational product will be administered in the evening once daily for all QD dose groups, and once in the morning and once in the evening for the BID dose groups.

Inclusion criteria

• Agreeing to follow the study treatment regimen and visit plan, voluntarily enroll the study, and sign the informed consent form (ICF) in writing;
• Male, aged ≥ 18 years, in good general health;
• Clinical diagnosis of AGA;
• Stage IIIv, IV and V according to Hamilton-Norwood scale.

Exclusion criteria

• Patients who have used external topical drugs for alopecia sites within 3 months prior to screening;
• Patients who have taken androgen replacement therapy； immunosuppressants, corticosteroids and other drugs that may interfere with the efficacy evaluation within 3 months prior to screening;
• Minoxidil use within 6 months prior to screening;
• Treatment with finasteride or dutasteride within 12 months prior to screening; Scalp radiation and/or laser or surgical therapy within 12 months prior to screening; History of malignancy;
• Other conditions that may affect compliance or ineligibility for participation of the study.