Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects
NCT ID: NCT05245578
Last Updated: 2022-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2021-11-16
2022-01-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KX01 ointment and Placebo ointment
KX01 ointment 1%
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.
Placebo ointment
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.
Interventions
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KX01 ointment 1%
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.
Placebo ointment
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
65 Years
MALE
Yes
Sponsors
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PharmaEssentia Japan K.K.
INDUSTRY
PharmaEssentia
INDUSTRY
Responsible Party
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Principal Investigators
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Hisakuni Sekino
Role: PRINCIPAL_INVESTIGATOR
Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic
Locations
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Medical Corporation HOUEIKAI, Sekino Clinical Pharmacology Clinic
Toshima-ku, Tokyo, Japan
Countries
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Other Identifiers
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B21-101
Identifier Type: -
Identifier Source: org_study_id
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