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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03080987
• Other study ID #: CR108306
• Secondary ID: 2016-004785-2564
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2017
• Est. completion date: June 25, 2018

Study information

• Verified date: October 2018
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-64179375 0.3 mg/kg
JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.
• JNJ-64179375 1.0 mg/kg
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
JNJ-64179375 2.5 mg/kg IV infusion on Day 1.

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

Drug:
• JNJ-64179375 (Dose to be Determined)
JNJ-64179375 IV infusion (Dose to be determined).

Locations

Country	Name	City	State
Japan	Souseikai Hakata Clinic	Fukuoka
United Kingdom	Hammersmith Medicines Research Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Japan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability	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
Primary	Part 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability	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
Secondary	Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-64179375	Cmax is the maximum observed plasma concentration.	Predose, Day 1, 2, 4, 7, 10, 14, 22, 29, 43, 57, 85 and 113 post-dose
Secondary	Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-64179375	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
Secondary	Part 1 and 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64179375	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
Secondary	Part 1: Total Systemic Clearance (CL) of JNJ-64179375	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
Secondary	Part 1: Apparent Volume of Distribution at Terminal Phase After Intravenous Administration (Vz) of JNJ-64179375	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
Secondary	Part 1 and 2: Terminal Half-Life (t1/2) of JNJ-64179375	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
Secondary	Part 2: Total Systemic Clearance Over Bioavailability After Subcutaneous (SC) Administration (CL/F) of JNJ-64179375 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
Secondary	Part 2: Apparent Volume of Distribution at Terminal Phase Over Bioavailability After Subcutaneous Administration (Vz/F) of JNJ-64179375	(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
Secondary	Part 2: Absolute Bioavailability (F) After Subcutaneous Administration of JNJ-64179375	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
Secondary	Part 1 and 2: Immunogenicity of JNJ-64179375	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
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Thrombin Time (TT)	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
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Prothrombin Time (PT)	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
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Activated Partial Thromboplastin time (aPTT)	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
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in Ecarin Clotting time (ECT)	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
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 on Platelet Function	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
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Thrombin Generation Assay (TGA)	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
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by D-dimer	The D-dimer assay is an enzyme immunoassay procedure for the quantitative determination of D-dimer.	Predose, Day 1 and 14 post-dose
Secondary	Part 1 and 2: Pharmacodynamic Effect of JNJ-64179375 as Assessed by Change in International Normalized Ratio (INR)	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
Secondary	Part 2: Time to Maximum Observed Plasma Concentration (Tmax) After Subcutaneous Administration of JNJ-64179375	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