NCT06783881进行中（未招募）1 期
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-12 in Healthy Subjects
Kylonova (Xiamen) Biopharma co., LTD.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.
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, Care Provider, Investigator)
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
- •Men and women aged 18 to 55 years old, inclusive;
- •Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive;
- •Protocol-defined elevated serum TG level;
- •Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
- •Willing to comply with protocol required visits and assessments, and provide written informed consent.
排除标准
- •History or evidence of a clinically significant disorder, condition or disease;
- •Received an investigational drug, vaccine or device within 3 months before dosing;
- •History of evidence of malignant tumor or Gilbert syndrome;
- •Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
- •History of alcohol abuse within 12 months before dosing;
- •History of drug abuse within 3 months before screening;
- •History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
- •History of stroke or myocardial infarction within 6 months before sceening;
- •Pregnant or breast-feeding women;
- •Other exclusion criteria applied per protocol.
研究组 & 干预措施
Kylo-12
Experimental
Single ascending doses of Kylo-12 administered subcutaneously (SC).
干预措施: Kylo-12 (Drug)
Placebo
Placebo Comparator
Administered SC.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: up to Week 24
次要结局
- Incidence of adverse events(up to week 48)
- Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)(up to Week 48)
- PK parameter of time of maximum observed concentration (Tmax)(up to Week 48)
- PK parameter of area under the concentration time curve (AUC)(up to Week 48)
- Change in serum ApoC3 and TG over time(up to Week 48)
- Percent change in serum ApoC3 and TG over time(up to Week 48)
研究者
研究点 (2)
Loading locations...
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