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Completed

NCT Number: NCT05380427

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

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.

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Key information

Conditions

AGA

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, Hangzhou, 310052, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

CU-40101

Drug

CU-40101，0.0025% CU-40101，0.005% CU-40101，0.01% CU-40101，0.02%

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cutia Therapeutics（Wuxi）Co.,Ltd

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 18, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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