A phase I study of STN1013400 ophthalmic solution in healthy adult male volunteer

JRCT ID: jRCT2031210208

Registered date:26/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Myopia
• Date of first enrollment: 28/07/2021
• Target sample size: 48
• Study type: Interventional
• Intervention(s): To assess the tolerability of STN1013400 ophthalmic solution, once dosing, dose escalation. (stage1) Next, repeated dosing which meet safety criteria in stage1, placebo-controlled. (stage2)

Outcome(s)

Primary Outcome

Safety: Adverse events and adverse drug reactions
Pharmacokinetics: Plasma pharmacokinetic

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male
• Include criteria: Subjects who can comply with scheduled visits and the examination and observation as specified in the clinical study protocol

Exclude criteria

1)Subjects have a disease and/or abnormal laboratory value which is considered inappropriate from safety evaluation perspective
2)Subjects who are inappropriate as participants in this study in the opinion of the investigator or sub investigator

Related Information

• Primary Sponsor: Migita Yukie