NCT07685210招募中1 期
A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial in Healthy Adult Participants in China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of GenSci144
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Adverse events and clinical safety indicators after a single dose.
研究概览
简要总结
This study is a Phase I single ascending dose clinical trial in which healthy adult volunteers were administered single oral doses of GenSci144 tablets at different levels. It was conducted using a randomized, double-blind, placebo-controlled design, primarily to evaluate the drug's safety and tolerability, while also exploring its pharmacokinetic and pharmacodynamic characteristics in the body, providing a basis for subsequent clinical use in the treatment of phenylketonuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 men and women aged 18 to 45, with at least 3 people of the same gender in each group.
- •BMI 19~26 kg/m², men weigh ≥50 kg, women ≥45 kg.
- •Voluntarily sign the informed consent form, fully aware of the research risks and procedures.
- •Use reliable contraception for 3 months after the last dose, no plans for pregnancy or sperm/egg donation.
排除标准
- •A family history of sudden death and serious neuropsychiatric disorders.
- •Major underlying conditions like gastrointestinal absorption problems, chronic liver, kidney, heart, and endocrine diseases.
- •Liver function, kidney function with eGFR<90, abnormal QTc interval, positive for various infectious diseases.
- •Drug allergies, drug abuse, recent participation in other clinical trials.
- •Drinking alcohol, smoking, taking grapefruit/amino acid supplements, and having a chaotic routine during the screening period.
- •Pregnant or breastfeeding women, people who can't tolerate blood draws or get faint from needles.
结局指标
主要结局
Adverse events and clinical safety indicators after a single dose.
时间窗: Sign informed consent until Day3 discharge.
Change in QT/QTc interval correction ΔΔQTc after dosing.
时间窗: Dynamic ECG monitoring from before to 24 hours after medication.
次要结局
- AUC0-t, AUC0-∞, Cmax, Tmax, t1/2, CL/F, Vz/F.(From before dosing to 48 hours after dosing.)
研究者
研究点 (1)
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