臨床研究等提出・公開システム

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

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

Omatsu Kazunori

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

senju-clinicaltrials@senju.co.jp

Clinical development division

Senju Pharmaceutical Co., Ltd.

6-4-3, Minatojima-Minamimachi, Chuo-ku, Kobe, Hyogo

+81-78-777-1018

senju-clinicaltrials@senju.co.jp

Not Recruiting

Nov. 15, 2024

Interventional

randomized controlled trial

single blind

active control

parallel assignment

treatment purpose

- 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

- 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

Both

healthy adult participants

Ocular administration of SJP-0170 or control drug and blood collection

Pharmacokinetics and safety (adverse events, etc.)

No

none