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

NCT ID: NCT03536325

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-31
• Study Completion Date: 2018-10-25

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Guselkumab Dose 1

Intervention Type: DRUG

Participants will receive Dose 1 of guselkumab on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo on Day 1.

Cohort 2: Guselkumab Dose 2 or Placebo

Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.

Group Type: EXPERIMENTAL

Guselkumab Dose 2

Intervention Type: DRUG

Participants will receive Dose 2 of guselkumab on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo on Day 1.

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.

Group Type: EXPERIMENTAL

Guselkumab Dose 3

Intervention Type: DRUG

Participants will receive Dose 3 of guselkumab on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo on Day 1.

Interventions

Guselkumab Dose 1

Participants will receive Dose 1 of guselkumab on Day 1.

Intervention Type: DRUG

Guselkumab Dose 2

Participants will receive Dose 2 of guselkumab on Day 1.

Intervention Type: DRUG

Guselkumab Dose 3

Participants will receive Dose 3 of guselkumab on Day 1.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo on Day 1.

Intervention Type: DRUG

Other Intervention Names

CNTO1959; CNTO1959; CNTO1959

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Souseikai Hakata Clinic

Fukuoka, , Japan

Countries

Japan

Other Identifiers

CNTO1959CRD1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108478

Identifier Type: -

Identifier Source: org_study_id