A randomized, participant- and investigator-masked, vehicle-controlled study to assess the safety, tolerability and pharmacokinetics of topical ocular SAF312 in Japanese healthy participants

Novartis Pharma. K.K.0 个研究点目标入组 36 人开始时间: 2022年2月1日最近更新: 2023年4月10日

试验速览

暂无简介。

•Written informed consent must be obtained before any assessment is performed
•Japanese healthy male and female participants of age 20 to 45 years (inclusive), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram(ECG), and laboratory tests at screening
•At screening, participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 30 kg/m
•BMI = Body weight(kg) / [Height (m)]2
•At screening, vital signs (body temperature, systolic and diastolic blood pressure(BP) and pulse rate) will be assessed in the sitting position. Sitting vital signs should be within the following ranges:
•body temperature between 35.0-37.5 degree Celsius
•systolic BP, 90-139 mmHg
•diastolic BP, 50-89 mmHg
•pulse rate, 40-90 bpm
•If vital signs are outside these ranges, the Investigator may obtain two additional readings, so that up to three consecutive assessments are made. At least the last reading must be within the ranges provided above in order for the participant to qualify.
•Able to communicate well with the investigator, to understand and comply with the requirements of the study
•For Part 3, participants should have baseline levels of eye sensitivity in the range of 50 to 60 mm (inclusive) as measured by the Cochet-Bonnet type esthesiometer at screening.

•Participants demonstrating any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, and based on the content of the Investigator's Brochure(IB), preclude the safe administration of test article or safe participation in this study
•History of any ocular surgery or laser within the past 6 months prior to screening
•History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia
•Participants with a history of acute eye disease (such as infection, corneal abrasion, or allergy) within the past 6 months from screening may be eligible if the disease is not currently active
•Any currently active ocular condition that requires use of topical eye drops
•Participants using CPAP or other sleep apnea devices
•Part 3 (esthesiometry) only, participants who have used contact lenses in the past 3 years or currently, in order to minimize variability in cornea sensitivity because of contact lens use

All safety endpoints

Including adverse events, vital signs, ECG, safety laboratory

Ocular safety endpoints

BCVA, IOP, slit lamp biomicroscopy, corneal staining, dilated fundus exam

未报告次要终点

发起方

Novartis Pharma. K.K.