A Randomized, Double-blind, Placebo-controlled Phase 1 Study of JMKX003948 Ophthalmic Suspension to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Dose(s) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
The study is a randomized, double-blind, placebo-controlled, phase 1 study of JMKX003948 Ophthalmic Suspension to evaluate the safety, tolerability and PK of single and multiple ascending doses in healthy participants.
Participant will be randomized to receive either JMKX003948 Ophthalmic Suspension (1%, 2%, 3% or 5%) or matching placebo (JMKX003948 Ophthalmic Suspension: placebo= 6: 2, N=8 per cohort).
Five cohorts (Cohort 1-5) are planned. Cohorts could also de-escalate to a lower concentration if current formulation was not tolerated (Cohort 1b, 2b and 3b). In case of de-escalation, Cohort 1b and 2b will continue to escalate to Cohort 1c and Cohort 2c, respectively.
Participants will be admitted to the site on Day -1 after screening (up to 28 days), and remain domiciled until Day 14 for Cohort 1-4, Day 8 for other cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and/or females, 18 to 45 years of age (inclusive) at the date of signed consent form.
- •Body mass index (BMI) greater than or equal to 18 and less than 32 (kg/m2) and a minimum body weight of 45 kg.
- •Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
- •Women of child-bearing potential and sexually active males willing to use highly effective methods of contraception from screening until 3 months after last dose of study drug. In addition, participants must not donate sperm/egg for the time period specified above.
排除标准
- •History of disease of ocular surface, fundus, central nervous system, psychiatric and psychological condition, cardiovascular system, kidney, liver, digestive system, respiratory system, or metabolic/endocrine system, or other disease that in the opinion of the Investigator (or medically qualified designee) may make participation unsafe for the participant or interfere with study evaluations.
- •Any abnormal examination with clinical significance may interfere with study evaluations in opinion of the Investigator (or medically qualified designee).
- •History of eye trauma or surgery including LASIK/LASEK.
- •Any corrected visual acuity < 20/20, or intraocular pressure ≥ 21 mmHg.
- •Clinically significant abnormalities on ophthalmic examination that would hinder the assessment of the eye or data collection at the discretion of the Investigator and/or ophthalmologist (or medically qualified designee).
研究组 & 干预措施
JMKX003948 Ophthalmic Suspension
干预措施: JMKX003948 Ophthalmic Suspension (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: From Day1 to up to Day14
Incidence of Adverse events (AEs)
Number of Participants With abnormal Ophthalmic examination
时间窗: From Day1 to up to Day14
Change from baseline of ophthalmic examination
次要结局
- Time to Cmax (Tmax)(From Day1 to up to Day14)
- Elimination half-life (t1/2)(From Day1 to up to Day14)
- Maximum concentration (Cmax)(From Day1 to up to Day14)
- Area under the concentration-time curve(From Day1 to up to Day14)