Phase I Clinical Trial of CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia

Exclusion Criteria

• •1. Allergic to minoxidil, finasteride or any component of the excipients, or allergic constitution;
• •3. For other systemic past medical history, current medical history and treatment history, those with any of the following conditions cannot participate in this study:
• •A. Underwent major surgery 2 months before screening, or lost blood or donated blood \> 500mL within 3 months before the first dose; B. Had a history of drug abuse; C. Used any drug that inhibits or induces liver drug metabolizing enzymes within 14 days before the first medication, or used any drug that inhibits or induces liver drug metabolizing enzymes and the last medication time was less than 5 half-lives of the drug, whichever is the longest; D. Used any prescription drugs, over-the-counter drugs, Chinese patent medicines, any herbal products and health products within 14 days before the first medication; E. Has a history of varicocele, sexual dysfunction or infertility; F. Participant with severe respiratory, digestive, urinary, immune, blood, endocrine, metabolic, neurological and psychiatric diseases in the past or currently, or poor disease control, which the investigators assess will significantly affect the safety and/or compliance of the participants in participating in this study; G. Participant with a history of malignant tumors but clinically cured for 5 years, or participant with completely resected carcinoma in situ, localized prostate cancer that has received radical treatment and has no disease recurrence, and completely resected basal cell or squamous cell skin cancer can participate in this study;
• •4. Regarding laboratory examinations, participant who meet any of the following criteria are excluded; A. Complete blood count: hemoglobin \<9 g/dL, platelets \<90×109/L, white blood cells \<3.0×109/L; B. Liver function: alanine aminotransferase or aspartate aminotransferase or total bilirubin \>2 times the upper limit of normal value; C. Renal function: eGFR \<60 mL/min/1.73m2; or abnormal blood creatinine and determined by the investigators to be clinically significant.
• •D. Infectious disease examination: participant with active hepatitis B (positive hepatitis B surface antigen and hepatitis B virus deoxyribonucleic acid HBV DNA ≥ upper limit of normal value), or positive hepatitis C virus antibody (HCV-Ab) and positive hepatitis C virus (HCV) RNA result, or positive Treponema pallidum antibody, or positive human immunodeficiency virus (HIV) antibody test result; E. 12-lead electrocardiogram examination: the average value of QT interval (QTcF) after QT interval correction using Fridericia formula, QTcF\>450 ms; F. Any result of breath alcohol test and urine drug screening is positive.
• •5. Participated in other interventional drug clinical trials and received the trial drugs within 3 months before the start of the trial;
• •6. Difficulty in venous blood collection (such as needle phobia, blood phobia, etc.);
• •7. The researcher believes that there are any other reasons that make the participant unsuitable for participation in this study.