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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

調査の概要

詳細な説明

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

研究の種類

介入

入学 (推定)

40

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100142
        • 募集
        • Peking University Third Hospital
        • コンタクト:
          • Haiyan Li
          • 電話番号:010-68966677-8507

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ:YKYY033 group
subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 injection
プラセボコンパレーター:YKYY033 Placebo group
subcutaneous injection, a single subcutaneous injection of the corresponding dose of YKYY033 Placebo

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
Adverse events(AEs)
時間枠:within 337 days after administration
within 337 days after administration
Serious adverse events (SAEs)
時間枠:within 337days after administration
within 337days after administration
Injection site reaction
時間枠:within 48 hours after administration
within 48 hours after administration

二次結果の測定

結果測定
時間枠
Cmax(Peak plasma concentration)
時間枠:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
AUC(Area under the plasma concentration versus time curve)
時間枠:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
Tmax(Time to maximum plasma concentration)
時間枠:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
T1/2(Half-Life)
時間枠:Pre-dose to 24 hours after administration
Pre-dose to 24 hours after administration
FXI (Coagulation Factor XI) antigen level
時間枠:within 337 days after administration
within 337 days after administration
FXI (Coagulation Factor XI) coagulation activity
時間枠: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)
時間枠:within 337 days after administration
within 337 days after administration

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月10日

一次修了 (推定)

2027年11月10日

研究の完了 (推定)

2028年7月1日

試験登録日

最初に提出

2026年8月23日

QC基準を満たした最初の提出物

2026年8月23日

最初の投稿 (実際)

2026年8月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月26日

QC基準を満たした最後の更新が送信されました

2026年8月23日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • CLSP-YKYY033-Z01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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