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.

Study Overview

• Status: Recruiting
• Conditions: AGA
• Intervention / Treatment: Drug: CU-40101

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gingko Qiu; Phone Number: 02152983119; Email: medical.co@cutiatx.com

Study Locations

• China
  • Hangzhou
    • Zhejiang, Hangzhou, China, 310052
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Bo Jiang; Phone Number: 0571-89713252; Email: jiangbo@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: CU-40101-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No