NCT07093255招募中1 期
A Phase 1b, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of FLQ-101 in Premature Neonates at High Risk of Developing ROP
FELIQS INC.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年4月3日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Frequency of adverse events
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy outcomes following exposure to FLQ-101.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Days 至 5 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent is obtained from parent(s) or legal guardian.
- •Neonates born at 26 weeks +0 days and 27 weeks +6 days of gestation.
- •Male or female infants with a birth weight greater than or equal to 650 gm.
排除标准
- •Neonates with congenital malformation of the eye or any other ocular condition that may prevent or relevantly affect any of the assessments or procedures.
- •Neonates with serious congenital anomalies, severe congenital infection, and chromosomal abnormalities.
- •Neonates who are seriously ill and not expected to survive.
- •Neonates with heart disease, including cardiomyopathy, serious arrhythmias, and congenital heart disease. (Neonates with patent foramen ovale may be included in the study if clinically stable).
- •Neonates that are small for gestational age defined as having a weight <10th percentile at birth based on the Fenton growth charts for gestational age and sex.
- •Neonates with history of or ongoing intraventricular hemorrhage (IVH) grades 2, 3 or
- •Neonates with IVH grade 1 may be included in the study at the discretion of the PI.
- •Neonates with any other medical conditions or clinically significant comorbidities or circumstances that in the opinion of the investigator may have a relevant impact on study participation or any of the study assessments or procedures.
- •Infants scheduled to participate in other interventional clinical trials while participating in the study and until reaching end of study.
研究组 & 干预措施
FLQ-101
Experimental
干预措施: FLQ-101 (Drug)
结局指标
主要结局
Frequency of adverse events
时间窗: Day 1 to 36 weeks PMA(post menstrual age)
次要结局
- Pharmacokinetic parameters of FLQ-101(Day 1 to 24 hours post first oral dose)
- Pharmacodynamic parameters of FLQ-101(Day 1 to 24 hours post first oral dose)
研究者
研究点 (1)
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