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

NCT05380427 | Completed Phase 1 DMC

• 1 other identifier: CU-40101-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

AGA

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Single dose 29 days; Multiple dose 39 days

Study Arms (8)

Single Dose 1

EXPERIMENTAL

0.0025%(0.025 mg/mL)

Drug: CU-40101

Single Dose 2

EXPERIMENTAL

0.005%（于0.05 mg/mL）

Drug: CU-40101

Single Dose 3

EXPERIMENTAL

0.01%（0.1 mg/mL）

Drug: CU-40101

Single Dose 4

EXPERIMENTAL

0.02%（0.2 mg/mL）

Drug: CU-40101

Multiple Dose 1

EXPERIMENTAL

0.05%（0.05 mg/mL）

Drug: CU-40101

Multiple Dose 2

EXPERIMENTAL

0.01%（0.01 mg/mL）

Drug: CU-40101

Multiple Dose 3

EXPERIMENTAL

0.02%（0.02 mg/mL）

Drug: CU-40101

Placebo

PLACEBO COMPARATOR

Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400

Drug: CU-40101

Interventions

CU-40101 DRUG

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

Multiple Dose 1; Multiple Dose 2; Multiple Dose 3; Placebo; Single Dose 1; Single Dose 2; Single Dose 3; Single Dose 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cutia Therapeutics（Wuxi）Co.,Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, Hangzhou, 310052, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: May 18, 2022
• Study Start: August 15, 2022
• Primary Completion: November 15, 2023
• Study Completion: February 22, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)