此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of YKYY033 Injection

A Phase I, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Profile of YKYY033 Injection in Chinese Healthy Adult Participants

A phase 1 study to evaluate the safety and tolerability of a single administration of YKYY033 injection in healthy adult participants

研究概览

详细说明

This is a randomized, double-blind, ascending-dose Phase 1 clinical study to investigate the safety and tolerability of YKYY033 when administered in healthy adult male and female participants

研究类型

介入性

注册 (估计的)

40

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 招聘中
        • Peking University Third Hospital
        • 接触:
          • Haiyan Li
          • 电话号码:010-68966677-8507

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Participant must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
  2. Participant must be between 18 and 55 years of age (inclusive), male or female.
  3. Participant's body mass index (BMI) must be between 19 and 28 kg/m^2 (inclusive). The body weight should be ≥50 kg for men and ≥45 kg for women.

4.Participants (including their spouses or partners) are willing to sign the informed consent form and have no plans to have children or donate sperm (eggs) within 6-12 months after administration, and voluntarily take effective contraceptive measures (including abstinence, condoms, intrauterine devices, etc.) 5. Participants are able to communicate effectively with the investigators and understand and comply with the requirements of this study.

Exclusion Criteria:

  1. History or present history of clinically significant hematological, circulatory, respiratory, digestive, urinary, neurological, immune, endocrine, or psychiatric disorders, or other diseases that investigators believe may affect the safety of participants in the study.
  2. History or evidence of any abnormal bleeding or coagulation disorders, or there may be coagulation dysfunction (such as Von Willebrand disease, hemophilia), long-term or unexplained clinically significant bleeding, or evidence of frequent unexplained bruising or thrombosis, or have a history of spontaneous bleeding, or diseases with increased risk of bleeding (such as active and meaningful peptic ulcers judged by investigators.
  3. Individuals with a history of cardiovascular diseases, including but not limited to myocardial infarction, congenital heart disease, heart valve disease, coronary revascularization, angina, heart failure, and other heart diseases and arrhythmias that may cause QT prolongation; Or there may be other risk factors that lead to tip twisting ventricular tachycardia; Or there may be a history of atrial flutter, atrial fibrillation, or other conditions that may interfere with electrocardiogram measurements.
  4. History of intolerance to SC injection or significant abdominal scars that may significantly affect the administration of the investigational drug or the assessment of local safety.
  5. Major surgery within 6 months prior to screening (such as heart, brain, liver, kidney, knee replacement, or other surgeries that researchers believe may affect the conduct of the trial), or have undergone surgeries that may affect drug absorption, distribution, metabolism or excretion, or plan to undergo surgery during the study.
  6. Evidence of acute febrile illness or active infection within 7 days prior to administration.
  7. An abnormal result judged by the physician during the screening period to be clinically significant in physical examination, vital signs examination, laboratory examinations (blood routine, urine routine, blood biochemistry) or other auxiliary examination results.
  8. The coagulation time (APTT), prothrombin time (PT), or international normalized ratio (INR) are outside the normal range specified by the laboratory (except for those who are mildly below the lower limit of normal (LLN) and have no other coagulation function indicators combined with abnormalities) during the screening period.
  9. An abnormal result judged by the physician to be clinically significant in the 12-lead electrocardiogram, or the adjusted QTc interval ≥450 ms for males and ≥470 ms for females, or PR interval ≥210 ms, or QRS interval ≥210 ms.
  10. During the screening process, any of the urine drug abuse screening results were positive, or screen for individuals with a history of drug abuse or drug use within the past 3 years.
  11. Any one of hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody and HIV antibody was positive during screening.
  12. Pregnant women (with positive serum pregnancy results) and lactating women during screening.
  13. Those who have special dietary requirements and cannot accept unified dietary arrangements during the study.
  14. Drink strong tea, coffee, and/or caffeinated beverages daily (≥ 8 cups/day, 1 cup=250mL) within 3 months before administration; Or ingested any food or drink containing caffeine (such as coffee, strong tea, cola, chocolate, etc.) or xanthine (such as animal viscera, sardine, soy products, etc.) within 48 hours before randomization.
  15. Smoking more than 5 cigarettes per day within the first 3 months of screening; During hospitalization, the use of any tobacco products (such as cigarettes, electronic cigarettes) cannot be stopped.
  16. The average weekly alcohol consumption within the first 3 months of screening is greater than 14 units (1 unit of alcohol ≈ 355 mL of beer or 45 mL of spirits with an alcohol content of 40% or 150 mL of wine); Or the alcohol breath test result is positive; Or randomly select individuals who cannot abstain from alcohol within the first 48 hours and during hospitalization.
  17. There is any previous history of small interfering RNA (siRNA) or antisense oligonucleotides (ASO) drug therapy (including clinical trials).
  18. Those who use anticoagulant or thrombotic drugs (such as warfarin, vitamin K1, etc.) within 4 weeks before administration or during the trial study.
  19. Participants who have used any drugs that investigators believe may affect the pharmacokinetic characteristics of the investigational drug within 2 weeks prior to administration, including prescription drugs, over-the-counter drugs, herbal medicines, health supplements, vitamins, etc
  20. Received any vaccine within 8 weeks prior to administration, or planned to receive the vaccine during the study period.
  21. Have participated in any other clinical trials within the past 3 months prior to screening.
  22. Blood donation or significant blood loss (>400 mL) within the first 3 months of screening; Or receiving blood transfusions or using blood products (such as albumin); Or plan to donate blood during the study.
  23. History of drug allergy or any severe allergic disease.
  24. Difficulty in venous blood collection or intolerance to venipuncture, or history of needle and blood dizziness.
  25. Due to other reasons, the study may not be completed, or it may be deemed unsuitable for inclusion by the investigator.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:YKYY033 group
subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 injection
安慰剂比较:YKYY033 Placebo group
subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 Placebo

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Adverse events(AEs)
大体时间:within 337 days after administration
within 337 days after administration
Serious adverse events (SAEs)
大体时间:within 337days after administration
within 337days after administration
Injection site reaction
大体时间:within 48 hours after administration
within 48 hours after administration

次要结果测量

结果测量
大体时间
Cmax(Peak plasma concentration)
大体时间:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
AUC(Area under the plasma concentration versus time curve)
大体时间:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
Tmax(Time to maximum plasma concentration)
大体时间:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
T1/2(Half-Life)
大体时间:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
FXI (Coagulation Factor XI) antigen level
大体时间:within 337 days after administration
within 337 days after administration
FXI (Coagulation Factor XI) coagulation activity
大体时间:within 337 days after administration
within 337 days after administration
The time between the start of the q wave and the end of the t wave on an electrocardiogram/Corrected QT interval(QT/QTc) in 12-lead electrocardiogram (ECG)
大体时间:within 337 days after administration
within 337 days after administration

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月10日

初级完成 (估计的)

2027年11月10日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年8月23日

首先提交符合 QC 标准的

2026年8月23日

首次发布 (实际的)

2026年8月26日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月23日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • CLSP-YKYY033-Z01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅