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 Identifier: NCT05380427
• Recruitment Status: Not yet recruiting
• First Posted: May 18, 2022
• Last Update Posted: June 30, 2022
• Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd
• Information provided by (Responsible Party): Cutia Therapeutics（Wuxi）Co.,Ltd

Study Description

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

Study Design

• 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

Arms and Interventions

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%

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

More Information

• Responsible Party: Cutia Therapeutics（Wuxi）Co.,Ltd
• ClinicalTrials.gov Identifier: NCT05380427
• Other Study ID Numbers: CU-40101-101
• First Posted: May 18, 2022
• Last Update Posted: June 30, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical