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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Guselkumab Dose 3; Drug: Placebo; Drug: Guselkumab Dose 2; Drug: Guselkumab Dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03536325

CNTO1959CRD1002 (Other Identifier)

CR108478

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Cohort 1: Guselkumab Dose 1 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Guselkumab Dose 1

Drug: Placebo

Cohort 2: Guselkumab Dose 2 or Placebo

Experimental group

Description:

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

Treatment:

Drug: Guselkumab Dose 2

Drug: Placebo

Cohort 3: Guselkumab Dose 3 or Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Guselkumab Dose 3