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 range18 Years – 65 Years
SexMALE
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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.
Exclusion criteria
✕. 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;
What they're measuring
1
Safety and tolerability
Timeframe: From baseline to 4 days post last administration
✕. 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.