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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-64304500

Study type: Interventional

Funder types: Industry

Identifiers

NCT03002025

64304500CRD1001 (Other Identifier)

CR108267

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 4 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: JNJ-64304500

Drug: Placebo

Cohort 2: JNJ-64304500 150 mg or placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-64304500

Drug: Placebo

Cohort 3: JNJ-64304500 400 mg or placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-64304500

Drug: Placebo

Cohort 4: JNJ-64304500 150 mg or placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-64304500

Drug: Placebo