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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05380427
Recruitment Status : Not yet recruiting
First Posted : May 18, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Cutia Therapeutics(Wuxi)Co.,Ltd

Brief 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 with androgenic alopecia.

Condition or disease Intervention/treatment Phase
AGA Drug: CU-40101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 27, 2022
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Dose 1
0.0025%(0.025 mg/mL)
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%

Experimental: Single Dose 2
0.005%(于0.05 mg/mL)
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%

Experimental: Single Dose 3
0.01%(0.1 mg/mL)
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%

Experimental: Single Dose 4
0.02%(0.2 mg/mL)
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%

Experimental: Multiple Dose 1
0.05%(0.05 mg/mL)
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%

Experimental: Multiple Dose 2
0.01%(0.01 mg/mL)
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%

Experimental: Multiple Dose 3
0.02%(0.02 mg/mL)
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%

Placebo Comparator: Placebo
Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400
Drug: CU-40101
CU-40101,0.0025% CU-40101,0.005% CU-40101,0.01% CU-40101,0.02%




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject has provided written informaed consent.
  2. Subject is male, 18-55 years old.
  3. Subject has a clinical diagnosis of moderate to severe AGA in temple and vertex region, Ⅲ to Ⅶ on the Modified Norwood-Hamilton Scale.
  4. Subject has a body mass index(BMI) of 19 to 28 kg/㎡ inclusive and body weight not less than 50kg.
  5. 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
  6. Subjects (including partners) are willing to take effective contraceptive measures voluntarily within 3 months from signing the informed consent to the last dose.

Exclusion Criteria:

  1. Allergic to the study drug or any ingredient in the study drug
  2. Skin damage or abnormality at the administration site may affect drug absorption or evaluation, such as dermatitis, scar, tattoo, sunburn, etc
  3. 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
  4. 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
  5. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05380427


Contacts
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Contact: Gingko Qiu 02152983119 medical.co@cutiatx.com

Locations
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China, Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhejiang, Hangzhou, China, 310052
Contact: Bo Jiang    0571-89713252    jiangbo@zju.edu.cn   
Sponsors and Collaborators
Cutia Therapeutics(Wuxi)Co.,Ltd
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Responsible Party: Cutia Therapeutics(Wuxi)Co.,Ltd
ClinicalTrials.gov Identifier: NCT05380427    
Other Study ID Numbers: CU-40101-101
First Posted: May 18, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical