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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

Primary Purpose

AGA

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CU-40101

About this trial

This is an interventional treatment trial for AGA

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Arm Label

Single Dose 1

Single Dose 2

Single Dose 3

Single Dose 4

Multiple Dose 1

Multiple Dose 2

Multiple Dose 3

Placebo

Arm Description

0.0025%(0.025 mg/mL)

0.005%（于0.05 mg/mL）

0.01%（0.1 mg/mL）

0.02%（0.2 mg/mL）

0.05%（0.05 mg/mL）

0.01%（0.01 mg/mL）

0.02%（0.02 mg/mL）

Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400

Outcomes

Primary Outcome Measures

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.

Vital signs

Descriptive statistics summarizing changes in heart rate will be compared between baseline levels at each predetermined point in time.

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.

Vital signs

Descriptive statistics summarizing changes in body temperature will be compared between baseline levels at each predetermined point in time.

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.

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.

Vital signs

Descriptive statistics summarizing changes in respiration will be compared between baseline levels at each predetermined point in time.

Assessment of topical skin tolerance

The number of erythema, burning/tingling, dryness, pruritus, desquamation of skin and hyperpigmentation after dosing.

Secondary Outcome Measures

Full Information

NCT ID

NCT05380427

First Posted

March 28, 2022

Last Updated

September 26, 2023

Sponsor

Cutia Therapeutics（Wuxi）Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05380427

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 15, 2022 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cutia Therapeutics（Wuxi）Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the safety and tolerability of CU-40101 liniment as a single and multiple topical application in adult male androgenic alopecia subjects； 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

AGA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single Dose 1

Arm Type

Experimental

Arm Description

0.0025%(0.025 mg/mL)

Arm Title

Single Dose 2

Arm Type

Experimental

Arm Description

0.005%（于0.05 mg/mL）

Arm Title

Single Dose 3

Arm Type

Experimental

Arm Description

0.01%（0.1 mg/mL）

Arm Title

Single Dose 4

Arm Type

Experimental

Arm Description

0.02%（0.2 mg/mL）

Arm Title

Multiple Dose 1

Arm Type

Experimental

Arm Description

0.05%（0.05 mg/mL）

Arm Title

Multiple Dose 2

Arm Type

Experimental

Arm Description

0.01%（0.01 mg/mL）

Arm Title

Multiple Dose 3

Arm Type

Experimental

Arm Description

0.02%（0.02 mg/mL）

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Liniment containing anhydrous ethanol, propylene glycol and polyethylene glycol 400

Intervention Type

Drug

Intervention Name(s)

CU-40101

Intervention Description

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

Primary Outcome Measure Information:

Title

AE and SAE

Description

Time Frame