NCT07038941已完成1 期
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of Single and Multiple Doses of CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia
Beijing Dayspring Pharmaceutical Technology Co., Ltd1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年3月19日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
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:
- Whether single and repeated daily doses of CG2001 are safe and well-tolerated
- How much of the drug, if any, enters the bloodstream (pharmacokinetics)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all of the following criteria to be included:
- •Voluntarily sign the informed consent form approved by the ethics committee before any research procedures begin;
- •Be able to understand and comply with the requirements of the protocol, and agree to cooperate in completing all research procedures for research visits;
- •Male, aged 18-65 years (including critical values);
- •Body mass index is 18-28 kg/m2 (including critical values), and weight must not be less than 50 kg;
- •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;
- •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.
排除标准
- •Participants who meet any of the following conditions are not eligible to participate in this study:
- •Allergic to minoxidil, finasteride or any component of the excipients, or allergic constitution;
- •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;
- •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;
- •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.
- •Participated in other interventional drug clinical trials and received the trial drugs within 3 months before the start of the trial;
- •Difficulty in venous blood collection (such as needle phobia, blood phobia, etc.);
- •The researcher believes that there are any other reasons that make the participant unsuitable for participation in this study.
研究组 & 干预措施
Arm 1
Experimental
5% minoxidil and 0.025% finasteride, 1 gram Only once on Day 1
干预措施: CG2001 (Drug)
Arm 2
Experimental
5% minoxidil and 0.05% finasteride, 1 gram Once a day from Day 1 to Day 7
干预措施: CG2001 (Drug)
Arm 3
Experimental
5% minoxidil and 0.075% finasteride, 1 gram Once a day from Day 1 to Day 7
干预措施: CG2001 (Drug)
Arm 4
Experimental
5% minoxidil and 0.1% finasteride, 1 gram Once a day from Day 1 to Day 7
干预措施: CG2001 (Drug)
Arm 5
Experimental
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
干预措施: CG2001 (Drug)
Arm 6
Placebo Comparator
Placebo foam, 1 gram Once a day from Day 1 to Day 7
干预措施: Placebo foam (Drug)
Arm 7
Placebo Comparator
Placebo foam, 1 gram Once a day on Day 1, twice daily on Day 2 to Day 6, once a day on Day 7
干预措施: Placebo foam (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: From baseline to 4 days post last administration
Incidence and severity of adverse events, vital signs, physical examination, laboratory tests, electrocardiogram, etc.
次要结局
- Single dose: Area under the plasma concentration versus time curve(Within 1 hour before and 24 hours after intervention administration)
- Single dose: Peak Plasma Concentration(Within 1 hour before and 24 hours after intervention administration)
- Single dose: Time to first peak drug concentration(Within 1 hour before and 24 hours after intervention administration)
- Single dose: Terminal elimination half-life(Within 1 hour before and 24 hours after intervention administration)
- Single dose: Volume of Distribution(Within 1 hour before and 24 hours after intervention administration)
- Single dose: Clearance rate(Within 1 hour before and 24 hours after intervention administration)
- Single dose: Elimination rate(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Area under the plasma drug concentration versus time curve at steady state(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Peak Plasma Concentration;(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Trough Plasma Concentration(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Accumulation index(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Average steady-state plasma drug concentration(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Apparent volume of distribution at steady state(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Apparent clearance rate at steady state(Within 1 hour before and 24 hours after intervention administration)
- Multiple dose: Half-life at steady state(Within 1 hour before and 24 hours after intervention administration)
研究者
研究点 (1)
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