A phase I study of STN1013600 ophthalmic solution in healthy adult male volunteer

JRCT ID: jRCT2031210614

Registered date:18/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Presbyopia
• Date of first enrollment: 18/02/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): To assess the tolerability of STN1013600 ophthalmic solution, by single dose, dose escalation. Next, to assess the tolerability of STN1013600 ophthalmic solution, by repeat dose which meet safety criteria in single dose.

Outcome(s)

• Primary Outcome: Safety: Adverse events and adverse drug reactions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

Subjects who can comply with scheduled visits, 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