Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects

Study Overview
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Brief Summary
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Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects

Detailed Description
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A baseline evaluation of the patch sites will be performed immediately prior to application of the patches to ensure that no conditions, markings, or coloration of the skin will interfere with interpretation of the study results. A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01KX2-391 ointment 1% and 2 sites for Placebo vehicle ointment. One set (KX01 ointment 1% IP and Placebo ointment vehicle patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions. The distance between the patches will be no less than one centimeter. The numbering of the test sites will remain the same throughout the study. The sites will be marked with an indelible, surgical marker.

Official Title
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Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese Healthy Male Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: KX01 ointment 1%
* Drug: Placebo ointment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male adult, whose age 20-65 years old Exclusion Criteria: History of photosensitivity or photoallergy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KX01 ointment and Placebo ointment<br> | Drug: KX01 ointment 1%<br>* A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions.<br>Drug: Placebo ointment<br>* A total of 4 application sites (2 cm x 2 cm each) will be marked on each subject's back, placing 2 sites for KX01 ointment 1% and 2 sites for Placebo ointment. One set (KX01 ointment 1% and Placebo ointment patches) will be designated for irradiation and the other set will remain non-irradiated under open conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of skin irritation at application site | Degree of skin irritation will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study. | 9 days | 
| Phototoxic potential at application site | Phototoxic potential will be evaluated according to the criteria (response scores and response notations). The same evaluator, if possible, should perform the assessment throughout the study. | 9 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety |  | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin Irritation, Phototoxicity