Phase I Clinical Trial of CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia (NCT07038941) | Clinical Trial Compass
CompletedPhase 1
Phase I Clinical Trial of CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia
China44 participantsStarted 2024-03-19
Plain-language summary
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)
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and tolerability
Timeframe: From baseline to 4 days post last administration
. 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:
. 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.
. 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.