A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants

A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Subjects

The purpose of this study is to assess the safety and tolerability of guselkumab following single-dose intravenous (IV) infusion in Japanese healthy male participants.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Guselkumab Dose 1; Drug: Placebo; Drug: Guselkumab Dose 2; Drug: Guselkumab Dose 3

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • SOUSEIKAI Hakata Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Participants must be healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, urinalysis, measurement of vital signs, and electrocardiogram (ECG)
• Must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 16 weeks after study drug administration
• Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study, if the inpatient site allows. However, if smoking is not allowed in the inpatient site, smokers will not be allowed to smoke while inpatient cannot use nicotine replacement products during the inpatient period, but may smoke at other times during the study, up to the maximum stated above
• Must agree to abstain from alcohol intake 48 hours before study drug administration and during the inpatient period of the study. After this time, participants must not consume more than 10 grams of alcohol per day for the duration of 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, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Has had major surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
• Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
• Any medical contraindications preventing study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Guselkumab Dose 1 or Placebo; Participants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1.	Drug: Guselkumab Dose 1; Participants will receive Dose 1 of guselkumab on Day 1.; Other Names: CNTO1959; Drug: Placebo; Participants will receive matching placebo on Day 1.
Experimental: Cohort 2: Guselkumab Dose 2 or Placebo; Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.	Drug: Placebo; Participants will receive matching placebo on Day 1.; Drug: Guselkumab Dose 2; Participants will receive Dose 2 of guselkumab on Day 1.; Other Names: CNTO1959
Experimental: Cohort 3: Guselkumab Dose 3 or Placebo; Participants will receive Dose 3 of guselkumab or matching placebo as an IV infusion on Day 1 based on safety data results received from Cohort 1 and 2.	Drug: Placebo; Participants will receive matching placebo on Day 1.; Drug: Guselkumab Dose 3; Participants will receive Dose 3 of guselkumab on Day 1.; Other Names: CNTO1959

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	An AE 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 approximately 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Serum Concentration (Cmax)	The Cmax is the maximum observed serum concentration.	Day 1: predose, end of infusion (EOI) and 8 hours (h) post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113
Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time Corresponding to the Last Quantifiable Plasma Concentration (AUC[0-last])	The AUC(0-last) is the area under the serum concentration-time curve from time 0 to last quantifiable concentration.	Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])	The AUC(0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.	Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113
Terminal half-life (t1/2)	Terminal half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).	Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113
Total Systemic Clearance (CL)	CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose is estimated by dividing the total administered dose by the plasma Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]).	Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113
Volume of Distribution (Vz)	The Vz is total volume of distribution at terminal phase after IV administration, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.	Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113
Number of Participants with Antibodies to Guselkumab	Number of participants with antibodies to guselkumab will be reported.	Day 1: predose; and Days 15, 29, 57, and 113

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2018
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: CR108478; CNTO1959CRD1002 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes