A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Participants

NCT ID: NCT03002025

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-10
• Study Completion Date: 2017-09-09

Brief Summary

The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese male participants.

Conditions

Healthy

Study Design

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

Study Groups

Cohort 1: JNJ-64304500 50 milligram (mg) or placebo

Participants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo to JNJ-64304500 as SC injection.

Cohort 2: JNJ-64304500 150 mg or placebo

Participants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo to JNJ-64304500 as SC injection.

Cohort 3: JNJ-64304500 400 mg or placebo

Participants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo to JNJ-64304500 as SC injection.

Cohort 4: JNJ-64304500 150 mg or placebo

Participants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1.

Group Type: EXPERIMENTAL

JNJ-64304500

Intervention Type: DRUG

Participants will receive JNJ-64304500 as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive matching placebo to JNJ-64304500 as SC injection.

Interventions

JNJ-64304500

Participants will receive JNJ-64304500 as SC injection.

Intervention Type: DRUG

Placebo

Participants will receive matching placebo to JNJ-64304500 as SC injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of the study including the procedures required and are willing to participate in the study
• Participant must be willing and able to adhere to the study visit schedule, prohibitions and restrictions specified in the protocol, and other protocol requirements
• Participant must have a body weight in the range of 60 to 90 kilogram (kg), inclusive, and a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2)
• Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
• Participant must be a non-smoker for at least 3 months prior to study enrollment

Exclusion Criteria

• Participant has a 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, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
• Participant has or has had a serious infection (example, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 2 months prior to screening
• Participant has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, and aspergillosis) prior to screening
• Participant has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis prior to screening
• If participant has had a chest radiograph within 3 months before study drug administration radiograph that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB)

• 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

Tokyo, , Japan

Countries

Japan

Other Identifiers

64304500CRD1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108267

Identifier Type: -

Identifier Source: org_study_id