SJP-0170 Phase I study -Pharmacokinetic study in healthy adult participants -

JRCT ID: jRCT2051240176

Registered date:14/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: healthy adult participants
• Date of first enrollment: 15/11/2024
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Ocular administration of SJP-0170 or control drug and blood collection

Outcome(s)

• Primary Outcome: Pharmacokinetics and safety (adverse events, etc.)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 35age old
• Gender: Both

Include criteria

- Healthy Japanese aged 18 to 35 years (inclusive) at the time of informed consent.
- Principal or sub investigator determined the participant's eligibility for enrollment into the study.
- Meet the other protocol-specified inclusion criteria

Exclude criteria

- Clinically diagnosed any diseases whether under treatment or not.
- History of serious systemic/psychiatric disease
- Positive for either HBs antigen, syphilis seroreaction, HCV antibody, or HIV antigen/antibody
- Intake of caffeines- or alcohol-containing beverages during the period specified in protocol, or use of nicotine-containing product during the period specified in protocol
- History of any ocular surgery or traumatic eye injuries which is ineligible to participate the study
- History of any drug-induced allergy
- Use of any medications during the period specified in protocol.
- History of participation in other clinical studies and administered any drugs during the period specified in protocol or be scheduled to participate in other clinical studies during this study.
- Requiring use of contact lenses or scheduled to undergo any treatment which deemed to be affected the clinical assessment of investigational product by PI/SI during the period specified in protocol.
- Pregnant, possibly pregnant or breast-feeding. Desire for childbearing during the study. Disagree to adhere to practice adequate contraception or no sperm donation during the study.
- Have judged inappropriate to participate in the study by investigator.
- Meet the other protocol-specified exclusion criteria

Related Information

• Primary Sponsor: Omatsu Kazunori