NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051230128

Registered date:11/11/2023

ROH-001 ophthalmic solution phase I clinical trial -Single and multiple dose study-

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHealthy volunteer
Date of first enrollment26/12/2023
Target sample size48
Countries of recruitment
Study typeInterventional
Intervention(s)Ophthalmic administration of ROH-001 or placebo

Outcome(s)

Primary OutcomeSafety, pharmacokinetics
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 35age old
GenderMale
Include criteriaJapanese healthy adult male, >=18 and <=35 of age, >=18.5 and <25.0 of BMI
Exclude criteria1) Subject with a serious history of eye, brain, liver, kidney, heart, lung, gastrointestinal, hematological, endocrine, metabolic, or neurological 2) Subjects with current or with a history of drug or alcohol abuse

Related Information

Contact

Public contact
Name Tomomi Mantani
Address 1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan Osaka Japan 544-8666
Telephone +81-6-6758-6925
E-mail rohtocl@rohto.co.jp
Affiliation ROHTO Pharmaceutical Co., Ltd.
Scientific contact
Name Tomomi Mantani
Address 1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan Osaka Japan 544-8666
Telephone +81-6-6758-6925
E-mail rohtocl@rohto.co.jp
Affiliation ROHTO Pharmaceutical Co., Ltd.