AGAPhase 1NCT05380427
A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of CU-40101 Liniment in Single and Multiple Doses in Adult Male Androgenic Alopecia Subjects
A Phase 1 study testing CU-40101 in people with AGA, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 1 site in China.
Trial summary
1. To evaluate the safety and tolerability of CU-40101 liniment as a single and multiple topical application in adult male androgenic alopecia subjects； 2. To evaluate the pharmacokinetic (PK) characteristics of CU-40101 liniment administered as a single and multiple topical skin application in adult male subjects… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- AGA
- What is being tested?
- CU-40101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2022to 22 Feb 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 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subject has provided written informaed consent.
- Subject is male, 18-55 years old.
- Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, Ⅲ to Ⅶ on the Modified Norwood-Hamilton Scale.
- Subject has a body mass index(BMI) of 19 to 28 kg/㎡ inclusive and body weight not less than 50kg.
- According to the history, physical examination, vital signs, 12-lead electrocardiogram and laboratory examination results, the patient was in good health with no clinically significant abnormalities
- Subjects (including partners) are willing to take effective contraceptive measures voluntarily within 3 months from signing the informed consent to the last dose.
Who cannot join
- Allergic to the study drug or any ingredient in the study drug
- Skin damage or abnormality at the administration site may affect drug absorption or evaluation, such as dermatitis, scar, tattoo, sunburn, etc
- Subjects who currently have thyroid disease (including hyperthyroidism, hypothyroidism, etc.) or are currently receiving thyroxine replacement therapy. Thyroid function abnormalities on blood tests at the screening stage or thyroid ultrasound that the investigator judged to be clinically significant must be excluded
- Any surgical procedures performed within 3 months prior to screening, or planned during the study and within 1 month after the subject completed all study visits
- A history of clinically significant heart, liver, neurological, respiratory, hematological, digestive, immune, renal, or psychiatric disorders that the investigator believes may confound study results or affect drug absorption, distribution, metabolism, and excretion or place the subject at inappropriate risk
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, Hangzhou, 310052
About this study
- To evaluate the safety and tolerability of CU-40101 liniment as a single and multiple topical application in adult male androgenic alopecia subjects；
- To evaluate the pharmacokinetic (PK) characteristics of CU-40101 liniment administered as a single and multiple topical skin application in adult male subjects with androgenic alopecia.
- Conditions
- AGA
- Being tested
- CU-40101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CU-40101Drug
CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%
| Study group | Role | What they receive |
|---|---|---|
| Single Dose 1 | Experimental | 0.0025%(0.025 mg/mL) Receives: Drug: CU-40101 |
| Single Dose 2 | Experimental | 0.005%（于0.05 mg/mL） Receives: Drug: CU-40101 |
| Single Dose 3 | Experimental | 0.01%（0.1 mg/mL） Receives: Drug: CU-40101 |
| Single Dose 4 | Experimental | 0.02%（0.2 mg/mL） Receives: Drug: CU-40101 |
| Multiple Dose 1 | Experimental | 0.05%（0.05 mg/mL） Receives: Drug: CU-40101 |
| Multiple Dose 2 | Experimental | 0.01%（0.01 mg/mL） Receives: Drug: CU-40101 |
| Multiple Dose 3 | Experimental | 0.02%（0.02 mg/mL） Receives: Drug: CU-40101 |
| Placebo | Placebo comparator | Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400 Receives: Drug: CU-40101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and SAE
TEAE and SAE will be summarized by dose grouping based on systematic organ Classification (SOC), preferred term (PT) and severity, as well as their relationship to the study drug. Subjects who reported multiple adverse events within the same SOC and PT could only be counted once, according to the highest severity level.
Measured: Single dose 29 days; Multiple dose 39 days
Vital signs
Descriptive statistics summarizing changes in heart rate will be compared between baseline levels at each predetermined point in time.
Measured: Single dose 29 days; Multiple dose 39 days
Vital signs
Descriptive statistics summarizing changes in sitting blood pressure (systolic and diastolic) will be compared between baseline levels at each predetermined point in time.
Measured: Single dose 29 days; Multiple dose 39 days
Vital signs
Descriptive statistics summarizing changes in body temperature will be compared between baseline levels at each predetermined point in time.
Measured: Single dose 29 days; Multiple dose 39 days
12-lead ECG
The number of results of heart rate, QT, QTcF and PR interval will be collected.
Descriptive statistics summarizing changes of parameters above will be compared between baseline levels at each predetermined point in time.
Measured: Single dose 29 days; Multiple dose 39 days
Laboratory inspection
The number of results of blood routine examination, Blood Biochemical and routine urine examination will be collected Descriptive statistics summarizing changes of parameters above will be compared with baseline levels at each predetermined point in time.
Measured: Single dose 29 days; Multiple dose 39 days
Vital signs
Descriptive statistics summarizing changes in respiration will be compared between baseline levels at each predetermined point in time.
Measured: Single dose 29 days; Multiple dose 39 days
Assessment of topical skin tolerance
The number of erythema, burning/tingling, dryness, pruritus, desquamation of skin and hyperpigmentation after dosing.
Measured: Single dose 29 days; Multiple dose 39 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start15 Aug 2022
- Primary completion15 Nov 2023
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AGAStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380427
- Sponsor's protocol ID
- CU-40101-101
- Status last verified
- Sep 2024
- First submitted
- 28 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of CU-40101 Liniment in Single and Multiple Doses in Adult Male Androgenic Alopecia Subjects
- ClinicalTrials.gov ID
- NCT05380427
- Acronym / sponsor ID
- CU-40101-101
- Conditions
- AGA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 18 May 2022 (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.
- To evaluate the safety and tolerability of CU-40101 liniment as a single and multiple topical application in adult male androgenic alopecia subjects；
- To evaluate the pharmacokinetic (PK) characteristics of CU-40101 liniment administered as a single and multiple topical skin application in adult male subjects with androgenic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Single Dose 1 | Experimental | Drug: CU-401010.0025%(0.025 mg/mL) |
| Single Dose 2 | Experimental | Drug: CU-401010.005%（于0.05 mg/mL） |
| Single Dose 3 | Experimental | Drug: CU-401010.01%（0.1 mg/mL） |
| Single Dose 4 | Experimental | Drug: CU-401010.02%（0.2 mg/mL） |
| Multiple Dose 1 | Experimental | Drug: CU-401010.05%（0.05 mg/mL） |
| Multiple Dose 2 | Experimental | Drug: CU-401010.01%（0.01 mg/mL） |
| Multiple Dose 3 | Experimental | Drug: CU-401010.02%（0.02 mg/mL） |
| Placebo | Placebo comparator | Drug: CU-40101Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject has provided written informaed consent.
- Subject is male, 18-55 years old.
- Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, Ⅲ to Ⅶ on the Modified Norwood-Hamilton Scale.
- Subject has a body mass index(BMI) of 19 to 28 kg/㎡ inclusive and body weight not less than 50kg.
- According to the history, physical examination, vital signs, 12-lead electrocardiogram and laboratory examination results, the patient was in good health with no clinically significant abnormalities
Key exclusion criteria (5 listed)
- Allergic to the study drug or any ingredient in the study drug
- Skin damage or abnormality at the administration site may affect drug absorption or evaluation, such as dermatitis, scar, tattoo, sunburn, etc
- Subjects who currently have thyroid disease (including hyperthyroidism, hypothyroidism, etc.) or are currently receiving thyroxine replacement therapy. Thyroid function abnormalities on blood tests at the screening stage or thyroid ultrasound that the investigator judged to be clinically significant must be excluded
- Any surgical procedures performed within 3 months prior to screening, or planned during the study and within 1 month after the subject completed all study visits
- A history of clinically significant heart, liver, neurological, respiratory, hematological, digestive, immune, renal, or psychiatric disorders that the investigator believes may confound study results or affect drug absorption, distribution, metabolism, and excretion or place the subject at inappropriate risk
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 |
|---|---|---|
| CU-40101CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02% | Drug | Multiple Dose 1, Multiple Dose 2, Multiple Dose 3, Placebo, Single Dose 1, Single Dose 2, Single Dose 3, Single Dose 4 |
Primary outcome
AE and SAE
Time frame: Single dose 29 days; Multiple dose 39 days
TEAE and SAE will be summarized by dose grouping based on systematic organ Classification (SOC), preferred term (PT) and severity, as well as their relationship to the study drug. Subjects who reported multiple adverse events within the same SOC and PT could only be counted once, according to the highest severity level.
Vital signs
Time frame: Single dose 29 days; Multiple dose 39 days
Descriptive statistics summarizing changes in heart rate will be compared between baseline levels at each predetermined point in time.
Vital signs
Time frame: Single dose 29 days; Multiple dose 39 days
Descriptive statistics summarizing changes in sitting blood pressure (systolic and diastolic) will be compared between baseline levels at each predetermined point in time.
Vital signs
Time frame: Single dose 29 days; Multiple dose 39 days
Descriptive statistics summarizing changes in body temperature will be compared between baseline levels at each predetermined point in time.
12-lead ECG
Time frame: Single dose 29 days; Multiple dose 39 days
The number of results of heart rate, QT, QTcF and PR interval will be collected. Descriptive statistics summarizing changes of parameters above will be compared between baseline levels at each predetermined point in time.
Laboratory inspection
Time frame: Single dose 29 days; Multiple dose 39 days
The number of results of blood routine examination, Blood Biochemical and routine urine examination will be collected Descriptive statistics summarizing changes of parameters above will be compared with baseline levels at each predetermined point in time.
Vital signs
Time frame: Single dose 29 days; Multiple dose 39 days
Descriptive statistics summarizing changes in respiration will be compared between baseline levels at each predetermined point in time.
Assessment of topical skin tolerance
Time frame: Single dose 29 days; Multiple dose 39 days
The number of erythema, burning/tingling, dryness, pruritus, desquamation of skin and hyperpigmentation after dosing.
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 19 Sep 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CU-40101 in people with AGA, run by Cutia Therapeutics（Wuxi）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 6 inclusion and 5 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 19 Sep 2024. 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?
AE and SAE (time frame: Single dose 29 days; Multiple dose 39 days). The study lists 8 primary outcomes in all. 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 19 Sep 2024.