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Completed

NCT Number: NCT03080987

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

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

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Souseikai Hakata Clinic, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-64179375 0.3 mg/kg

Drug

JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.

JNJ-64179375 1.0 mg/kg

Drug

JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).

JNJ-64179375 2.5 mg/kg

Drug

JNJ-64179375 2.5 mg/kg IV infusion on Day 1.

Placebo

Other

Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).

JNJ-64179375 (Dose to be Determined)

Drug

JNJ-64179375 IV infusion (Dose to be determined).

Primary outcomes

  1. Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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.

  2. Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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.

Secondary outcomes

  1. Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375

    Time frame: Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose

    Cmax is the maximum observed plasma concentration.

  2. Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375

    Time frame: 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.

  3. Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375

    Time frame: 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.

  4. Part 1: Total Systemic Clearance (CL) of JNJ-64179375

    Time frame: 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.

  5. Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375

    Time frame: 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.

  6. Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375

    Time frame: 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.

  7. Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 post-dose

    Time frame: 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.

  8. Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375

    Time frame: 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.

  9. Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375

    Time frame: 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.

  10. Part 1 and 2: Immunogenicity of JNJ-64179375

    Time frame: 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.

  11. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)

    Time frame: 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).

  12. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)

    Time frame: 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).

  13. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)

    Time frame: 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).

  14. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)

    Time frame: 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).

  15. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function

    Time frame: 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.

  16. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)

    Time frame: 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.

  17. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer

    Time frame: Predose, Day 1 and 14 post-dose

    The D-dimer assay is an enzyme immunoassay procedure for the quantitative determination of D-dimer.

  18. Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)

    Time frame: 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).

  19. Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2017
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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