Ascending Dose, Placebo Controlled Comparative Study of SJP-0130 in Healthy Japanese Subjects

JRCT ID: jRCT2051200086

Registered date:23/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Glaucoma
• Date of first enrollment: 24/11/2020
• Target sample size: 84
• Study type: Interventional
• Intervention(s): Administration of SJP-0130 or placebo and blood collection

Outcome(s)

• Primary Outcome: Safety and tolerability (adverse events etc.), pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 35age old
• Gender: Male

Include criteria

- Healthy Japanese male
- 20-35 years of age at the time of the informed consent
- Other protocol-specified inclusion criteria may apply

Exclude criteria

- History of severe systemic or mental illness
- History of allergy symptoms
- Judged by the investigator as being ineligible
- Other protocol-specified exclusion criteria may apply

Related Information

• Primary Sponsor: Tokushige Hideki