Male Pattern of Hair Loss, Androgenic AlopeciaPhase 1NCT07038941
Phase I Clinical Trial of CG2001 in Chinese Adult Male Participants With Androgenetic Alopecia
A Phase 1 study testing CG2001 in people with Male Pattern of Hair Loss, Androgenic Alopecia and Androgenetic Alopecia (AGA), run by Beijing Dayspring Pharmaceutical Technology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Pattern of Hair Loss, Androgenic Alopecia, Androgenetic Alopecia (AGA)
- What is being tested?
- CG2001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2024to 2 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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)
- Being tested
- CG2001, Placebo foam
- Keywords
- minoxidil, finasteride
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG2001Drug
combination of minoxidil and finasteride
Placebo foamDrug
Placebo foam
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 5% minoxidil and 0.025% finasteride, 1 gram Only once on Day 1 Receives: Drug: CG2001 |
| Arm 2 | Experimental | 5% minoxidil and 0.05% finasteride, 1 gram Once a day from Day 1 to Day 7 Receives: Drug: CG2001 |
| Arm 3 | Experimental | 5% minoxidil and 0.075% finasteride, 1 gram Once a day from Day 1 to Day 7 Receives: Drug: CG2001 |
| Arm 4 | Experimental | 5% minoxidil and 0.1% finasteride, 1 gram Once a day from Day 1 to Day 7 Receives: Drug: CG2001 |
| 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 Receives: Drug: CG2001 |
| Arm 6 | Placebo comparator | Placebo foam, 1 gram Once a day from Day 1 to Day 7 Receives: Drug: Placebo foam |
| 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 Receives: Drug: Placebo foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Incidence and severity of adverse events, vital signs, physical examination, laboratory tests, electrocardiogram, etc.
Measured: From baseline to 4 days post last administration
Secondary outcomes (15)
Single dose: Area under the plasma concentration versus time curve
Measured: Within 1 hour before and 24 hours after intervention administration
Single dose: Peak Plasma Concentration
Measured: Within 1 hour before and 24 hours after intervention administration
Single dose: Time to first peak drug concentration
Measured: Within 1 hour before and 24 hours after intervention administration
Single dose: Terminal elimination half-life
Measured: Within 1 hour before and 24 hours after intervention administration
Single dose: Volume of Distribution
Measured: Within 1 hour before and 24 hours after intervention administration
Single dose: Clearance rate
Measured: Within 1 hour before and 24 hours after intervention administration
Single dose: Elimination rate
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Area under the plasma drug concentration versus time curve at steady state
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Peak Plasma Concentration;
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Trough Plasma Concentration
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Accumulation index
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Average steady-state plasma drug concentration
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Apparent volume of distribution at steady state
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Apparent clearance rate at steady state
Measured: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Half-life at steady state
Measured: Within 1 hour before and 24 hours after intervention administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start19 Mar 2024
- Primary completion2 Jun 2024
- Study completion2 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Pattern of Hair Loss, Androgenic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Dayspring Pharmaceutical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Fang, MD, PhD, Principal investigator, Peking University People's HospitalJianzhong Zhang, MD, PhD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038941
- Sponsor's protocol ID
- CG2001-C-1
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07038941
- Acronym / sponsor ID
- CG2001-C-1
- Keywords
- minoxidil, finasteride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Beijing Dayspring Pharmaceutical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 2 Jun 2024 (actual)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: CG20015% minoxidil and 0.025% finasteride, 1 gram Only once on Day 1 |
| Arm 2 | Experimental | Drug: CG20015% minoxidil and 0.05% finasteride, 1 gram Once a day from Day 1 to Day 7 |
| Arm 3 | Experimental | Drug: CG20015% minoxidil and 0.075% finasteride, 1 gram Once a day from Day 1 to Day 7 |
| Arm 4 | Experimental | Drug: CG20015% minoxidil and 0.1% finasteride, 1 gram Once a day from Day 1 to Day 7 |
| Arm 5 | Experimental | Drug: CG20015% 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 |
| Arm 6 | Placebo comparator | Drug: Placebo foamPlacebo foam, 1 gram Once a day from Day 1 to Day 7 |
| Arm 7 | Placebo comparator | Drug: Placebo foamPlacebo foam, 1 gram Once a day on Day 1, twice daily on Day 2 to Day 6, once a day on Day 7 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG2001combination of minoxidil and finasteride | Drug | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5 |
| Placebo foamPlacebo foam | Drug | Arm 6, Arm 7 |
Primary outcome
Safety and tolerability
Time frame: From baseline to 4 days post last administration
Incidence and severity of adverse events, vital signs, physical examination, laboratory tests, electrocardiogram, etc.
15 secondary outcomes
Single dose: Area under the plasma concentration versus time curve
Time frame: Within 1 hour before and 24 hours after intervention administration
Single dose: Peak Plasma Concentration
Time frame: Within 1 hour before and 24 hours after intervention administration
Single dose: Time to first peak drug concentration
Time frame: Within 1 hour before and 24 hours after intervention administration
Single dose: Terminal elimination half-life
Time frame: Within 1 hour before and 24 hours after intervention administration
Single dose: Volume of Distribution
Time frame: Within 1 hour before and 24 hours after intervention administration
Single dose: Clearance rate
Time frame: Within 1 hour before and 24 hours after intervention administration
Single dose: Elimination rate
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Area under the plasma drug concentration versus time curve at steady state
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Peak Plasma Concentration;
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Trough Plasma Concentration
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Accumulation index
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Average steady-state plasma drug concentration
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Apparent volume of distribution at steady state
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Apparent clearance rate at steady state
Time frame: Within 1 hour before and 24 hours after intervention administration
Multiple dose: Half-life at steady state
Time frame: Within 1 hour before and 24 hours after intervention administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Fang, MD, PhD principal investigator
Peking University People's Hospital
Jianzhong Zhang, MD, PhD principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG2001 in people with Male Pattern of Hair Loss, Androgenic Alopecia and Androgenetic Alopecia (AGA), run by Beijing Dayspring Pharmaceutical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: From baseline to 4 days post last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025; AzTrials last refreshed its copy on 8 Nov 2026.