A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-11 in Healthy Subjects

Kylonova (Xiamen) Biopharma co., LTD.1 个研究点分布在 1 个国家目标入组 71 人2024年5月16日

适应症Cardiovascular Diseases

干预措施Kylo-11 Placebo

概览

阶段: 1 期
干预措施: Kylo-11
疾病 / 适应症: Cardiovascular Diseases
发起方: Kylonova (Xiamen) Biopharma co., LTD.
入组人数: 71
试验地点: 1
主要终点: Incidence of adverse events
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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-11 will be evaluated in approximately 60 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.

注册库

clinicaltrials.gov

开始日期

2024年5月16日

结束日期

2025年12月7日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Kylonova (Xiamen) Biopharma co., LTD.

责任方

Sponsor

入排标准

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 Lp(a) 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-11

Single ascending doses of Kylo-11 administered subcutaneously (SC).

干预措施: Kylo-11

Placebo

Administered SC.

干预措施: Placebo

结局指标

主要结局

Incidence of adverse events

时间窗: up to Week 24

次要结局

Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)(up to Week 48)
Incidence of adverse events(up to week 48)
Percent change in serum Lp(a) over time(up to Week 48)
PK parameter of area under the concentration time curve (AUC)(up to Week 48)
Change in serum Lp(a) over time(up to Week 48)
PK parameter of time of maximum observed concentration (Tmax)(up to Week 48)