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

JRCT ID: jRCT2051230128

Registered date:11/11/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 26/12/2023
• Target sample size: 48
• Study type: Interventional
• Intervention(s): Ophthalmic administration of ROH-001 or placebo

Outcome(s)

• Primary Outcome: Safety, pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 35age old
• Gender: Male
• Include criteria: Japanese healthy adult male, >=18 and <=35 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: Mantani Tomomi