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

Beijing Dayspring Pharmaceutical Technology Co., Ltd

Status and phase: Completed; Phase 1

Conditions: Male Pattern of Hair Loss, Androgenic Alopecia; Androgenetic Alopecia (AGA)

Treatments: Drug: Placebo foam; Drug: CG2001

Study type: Interventional

Funder types: Industry

Identifiers

NCT07038941

CG2001-C-1

Details and patient eligibility

About

This study is testing CG2001, a new medicine that is applied as a light foam to the scalp and is being developed to treat male-pattern hair loss (androgenetic alopecia). The main goals are to find out:

1. Whether single and repeated daily doses of CG2001 are safe and well-tolerated
2. How much of the drug, if any, enters the bloodstream (pharmacokinetics)

Enrollment: 44 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Participants must meet all of the following criteria to be included:

1. Voluntarily sign the informed consent form approved by the ethics committee before any research procedures begin;
2. Be able to understand and comply with the requirements of the protocol, and agree to cooperate in completing all research procedures for research visits;
3. Male, aged 18-65 years (including critical values);
4. Body mass index is 18-28 kg/m2 (including critical values), and weight must not be less than 50 kg;
5. Diagnosed with androgenic alopecia in accordance with the "Guidelines for the Diagnosis and Treatment of Androgenic Alopecia in Chinese" (2019), and manifested as frontal hairline recession or hair loss in the top scalp area, and meet the standards of grade III top type, grade IV and grade V of the Hamilton-Norwood classification;
6. Agree to use appropriate medical contraceptive methods to avoid pregnancy in female partners from the signing of the informed consent form until 28 days after the last dose.

Exclusion criteria

Participants who meet any of the following conditions are not eligible to participate in this study:

1. Allergic to minoxidil, finasteride or any component of the excipients, or allergic constitution;

2. Participants with any of the following conditions regarding past medical history, current medical history and treatment history of the skin (including the head skin) are not eligible to participate in this study; A. Participants who the investigator believes have scalp skin abnormalities or a history of scalp skin diseases that may interfere with the study evaluation; B. Participants with secondary alopecia such as malnutrition, drugs, endocrine (hypothyroidism or hyperthyroidism, hypoparathyroidism or hypopituitarism), iron deficiency anemia and systemic lupus erythematosus causing alopecia; C. Participants with alopecia areata, scarring alopecia or trichotillomania; D. Participants who have undergone hair transplantation, hair extensions, or need to wear a wig for a long time during the study treatment; E. Participants who have used systemic or topical corticosteroids or synthetic steroids for scalp within 3 months before screening; F. Participants who have received scalp radiation, phototherapy/laser, local injection of autologous platelet-rich plasma (PRP) or surgical treatment within 6 months before screening;

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 7 patient groups, including a placebo group

Arm 1

Experimental group

Description:

5% minoxidil and 0.025% finasteride, 1 gram Only once on Day 1

Treatment:

Drug: CG2001

Arm 2

Experimental group

Description:

5% minoxidil and 0.05% finasteride, 1 gram Once a day from Day 1 to Day 7

Treatment:

Drug: CG2001

Arm 3

Experimental group

Description:

5% minoxidil and 0.075% finasteride, 1 gram Once a day from Day 1 to Day 7

Treatment:

Drug: CG2001

Arm 4

Experimental group

Description:

5% minoxidil and 0.1% finasteride, 1 gram Once a day from Day 1 to Day 7

Treatment:

Drug: CG2001

Arm 5

Experimental group

Description:

5% minoxidil and 0.1% finasteride, 1 gram Once a day on Day 1, twice daily on Day 2 to Day 6, once a day on Day 7

Treatment:

Drug: CG2001

Arm 6

Placebo Comparator group

Description:

Placebo foam, 1 gram Once a day from Day 1 to Day 7

Treatment:

Drug: Placebo foam

Arm 7

Placebo Comparator group

Description:

Placebo foam, 1 gram Once a day on Day 1, twice daily on Day 2 to Day 6, once a day on Day 7

Treatment:

Drug: Placebo foam