ROH-202 ophthalmic solution phase I clinical trial -Single and multiple dose study-

JRCT ID: jRCT2051210197

Registered date:22/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy volunteer
• Date of first enrollment: 21/03/2022
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Ophthalmic dose of ROH-202 or placebo

Outcome(s)

• Primary Outcome: Safety, pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male
• Include criteria: Japanese healthy adult male, >=20 and <=45 of age, >=18.5 and <25.0 of BMI

Exclude criteria

1) 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

• Primary Sponsor: Kitano Takashi