NCT07766759尚未招募1 期
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FXR0906 in Healthy Adult Participants With or Without Elevated Triglycerides
Fosun Pharmaceutical Industrial Development (Shenzhen) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年8月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- safety
研究概览
简要总结
This is a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of FXR0906 injection or placebo in Chinese healthy adult volunteers with or without TG increase.
详细描述
This phase 1 study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single dose of FXR0906 injection in healthy adults with or without TG increase. Eligible enrolled participants will be randomized to 3 groups receiving FXR0906 (dose 1 or dose 2) or placebo on Day 1 and will be followed up for about 26 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Males or females aged ≥18 and ≤55 years at the time of screening;
- •Body mass index (BMI) ≥18.0 and ≤35.0 kg/m² at the time of screening, with female participants weighing >45 kg and male participants weighing >50 kg;
- •Fasting serum triglyceride (TG) level TG > 80 mg/dL (0.90 mmol/L) during screening;
- •Fasting LDL-C level ≥ 70 mg/dL (1.81 mmol/L) during screening;
排除标准
- •History or presence of clinically significant diseases/abnormality, or with clinically significant symptoms/signs, or self-reported diseases, unsuitable for enrollement in the judgement of the investigator.
- •2. Fasting blood glucose ≥7.0 mmol/L or HbA1c ≥6.5% during screening.
- •Use of any lipid-lowering treatment (e.g., drugs lowering LDL-C or TG), including but not limited to statins, ezetimibe, fibrates, omega-3 fatty acids, nutritional supplements, or other treatment regimens altering serum lipids within 30 days prior to screening, or use of any ASO or siRNA therapies lowering serum lipids within 12 months prior to screening..
- •4. Use of investigational drugs or instruments within 3 months prior to screening , or plans to participate in other clinical trials during this study.
- •Clinical laboratory parameters during screening meeting any of the following criteria:
- •ALT and/or AST >1.5 × ULN
- •ALT and/or AST > ULN and ≤1.5 × ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator
- •INR > ULN, deemed clinically significant and unsuitable for participation in the clinical trial by the investigator
- •Estimated glomerular filtration rate (eGFR) <90 mL/min/1.73 m2 (using MDRD formula)
- •Other examination abnormalities deemed clinically significant and unsuitable for participation in the clinical trial by the investigator
研究组 & 干预措施
Arm1: FXR0906 injection
Experimental
Dose 1 of FXR0906 injection
干预措施: Intervention1: FXR0906 injection (Drug)
Arm2: FXR0906 injection
Experimental
dose 2 of FXR0906 injection
干预措施: Intervention2: FXR0906 injection (Drug)
Arm3: placebo comparator: placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
safety
时间窗: through study completion, an average of 26 weeks
the incidence, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), and the relationship with FXR0906
次要结局
- peak concentration (Cmax)(Day0-Day3 ( Predose ~ post-dose 48h))
- time to peak (Tmax)(Day0-Day3 ( Predose ~ post-dose 48h))
- area under the blood drug concentration-time curve from 0 to 24 hours (AUC0-24)(Day0-Day3 ( Predose ~ post-dose 48h))
- area under the blood drug concentration-time curve from 0 to the last measurable blood drug concentration time t (AUC0-t)(Day0-Day3 ( Predose ~ post-dose 48h))
- area under the blood drug concentration-time curve from 0 to infinity (AUC0-inf)(Day0-Day3 ( Predose ~ post-dose 48h))
- terminal elimination rate constant (λz)(Day0-Day3 ( Predose ~ post-dose 48h))
- elimination half-life (t1/2)(Day0-Day3 ( Predose ~ post-dose 48h))
- apparent clearance (CL/F)(Day0-Day3 ( Predose ~ post-dose 48h))
- apparent volume of distribution (Vz/F)(Day0-Day3 ( Predose ~ post-dose 48h))
- Pharmacodynamic (PD) parameters(through study completion, an average of 26 weeks)
研究者
研究点 (1)
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