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A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants

2018年10月12日 更新者:Janssen Research & Development, LLC

A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects

The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.

調査の概要

研究の種類

介入

入学 (実際)

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。

研究場所

      • London、イギリス、NW10 7EW
        • Hammersmith Medicines Research Ltd
      • Fukuoka、日本、812-0025
        • Souseikai Hakata Clinic

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

20年~45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Must have been born in Japan of Japanese parents and maternal and paternal Japanese grandparents
  • Body mass index (weight kg/m^2) between 18 and 27 kilogram per square meter (kg/m^2) (inclusive), and body weight greater than 50 kg but less than 100 kg
  • Generally in good health on the basis of physical examinations, medical history, vital signs, laboratory tests, electrocardiograms (ECGs) and cardiac telemetry performed at Screening and/or prior to administration of the initial dose of study drug
  • Must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria:

  • History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, bleeding or thrombotic disorders (including any personal or family history of abnormal bleeding as assessed by a detailed bleeding history or blood dyscrasias), or with an underlying coagulopathy that may lead to a clinically relevant bleeding risk, autoimmune disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
  • Acute illness, including an upper respiratory infection (with or without fever), within 7 days prior to study drug administration or have had a major illness or hospitalization within 1 month prior to study drug administration
  • Clinically significant abnormal physical exam at Screening or Day -1
  • Clinically significant abnormal vital signs at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee
  • Clinically significant abnormal cardiac telemetry, or ECG at Screening, Day -1, or Day 1 (predose) as determined by the investigator or appropriate designee

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
実験的:Part 1: Cohort 1 (0.3 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 0.3 milligram per kilogram (mg/kg) intravenous (IV) dose of JNJ-64179375 or matching Placebo on Day 1.
JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
実験的:Part 1: Cohort 2 (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 1.0 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
実験的:Part 1: Cohort 3 (2.5 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single 2.5 mg/kg IV dose of JNJ-64179375 or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 2.5 mg/kg IV infusion on Day 1.
実験的:Part 1: Optional Cohort 1 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 IV infusion (Dose to be determined).
実験的:Part 1: Optional Cohort 2 (JNJ-64179375 or Placebo)
Participants will receive a single IV dose of JNJ-64179375 (dose to be determined) or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 IV infusion (Dose to be determined).
実験的:Part 2: SC Cohort (1.0 mg/kg of JNJ-64179375 or Placebo)
Participants will receive a single subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375 or matching Placebo on Day 1.
Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).

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
メジャーの説明
時間枠
Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
時間枠:Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Up to Day 113
Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
時間枠:Up to Day 113
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Up to Day 113

二次結果の測定

結果測定
メジャーの説明
時間枠
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Cmax is the maximum observed plasma concentration.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Total Systemic Clearance (CL) of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
CL is defined as total systemic clearance after intravenous administration of JNJ-64179375.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Vz is defined as the Apparent volume of distribution at terminal phase after intravenous administration.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Half-life is the time measured for the plasma concentration of drug to decrease by one half.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
CL/F is defined as total systemic clearance over bioavailability after SC administration.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
(Vz/F) is defined as Apparent Volume of distribution at terminal phase over bioavailability after SC administration of JNJ-64179375.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375
時間枠:Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
F is defined as absolute bioavailability after SC administration of JNJ-64179375.
Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Part 1 and 2: Immunogenicity of JNJ-64179375
時間枠:Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
Plasma samples will be collected and screened for antibodies binding to JNJ-64179375 and the titer of confirmed positive samples will be reported.
Predose, Day 7, 14, 29, 57, 85 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)
時間枠:Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in thrombin time (TT).
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)
時間枠:Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in prothrombin time (PT).
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)
時間枠:Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in activated partial thromboplastin time (aPTT).
Predose, Day 1, 2, 4, 7, 14, 29, 57 and 113 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)
時間枠:Predose, Day 1, 2, 4, and 14 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in Ecarin Clotting time (ECT).
Predose, Day 1, 2, 4, and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function
時間枠:Predose, Days 1 and 14 post-dose
Platelet function will be assessed by measuring platelet activation and aggregation in response to thrombin and other agonists and with the platelet function analyzer (PFA)100.
Predose, Days 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)
時間枠:Predose, Day 1 and 14 post-dose
The TGA is based on the premise that measurements of thrombin generation are indicative of the overall coagulating capacity of the individual.
Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer
時間枠:Predose, Day 1 and 14 post-dose
The D-dimer assay is an enzyme immunoassay procedure for the quantitative determination of D-dimer.
Predose, Day 1 and 14 post-dose
Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)
時間枠:Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
The pharmacodynamic effect of JNJ-64179375 on coagulation parameters will be assessed by measuring the change in international normalized ratio (INR).
Predose, Day 1, 2,4, 7, 14, 29, 57 and 113 post-dose
Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375
時間枠:Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration.
Predose, Day 1, 2,4, 7, 10, 14, 22, 29,43, 57, 85 and 113 post-dose

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)

2017年6月27日

一次修了 (実際)

2018年6月25日

研究の完了 (実際)

2018年6月25日

試験登録日

最初に提出

2017年3月10日

QC基準を満たした最初の提出物

2017年3月10日

最初の投稿 (実際)

2017年3月15日

学習記録の更新

投稿された最後の更新 (実際)

2018年10月15日

QC基準を満たした最後の更新が送信されました

2018年10月12日

最終確認日

2018年10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

  • CR108306
  • 2016-004785-25 (EudraCT番号)
  • 64179375EDI1002 (その他の識別子:Janssen Research & Development, LLC)

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米国FDA規制医薬品の研究

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米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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JNJ-64179375 0.3 mg/kgの臨床試験

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