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

PharmaEssentia

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: KX01 ointment 1%; Drug: Placebo ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT05245578

B21-101

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese male adult, whose age 20-65 years old

Exclusion criteria

• History of photosensitivity or photoallergy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

KX01 ointment and Placebo ointment

Experimental group

Treatment:

Drug: KX01 ointment 1%

Drug: Placebo ointment