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

NCT03002025 | Completed Phase 1

• 2 other identifiers: CR10826764304500CRD1001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

  Up to End of Study (Day 112)

Secondary Outcomes (9)

• Maximum Observed Serum Concentration (Cmax)

  Up to End of Study (Day 112)

• Time to Reach Maximum Observed Serum Concentration (Tmax)

  Up to End of Study (Day 112)

• Elimination Half-Life (t1/2)

  Up to End of Study (Day 112)

• Apparent Volume of Distribution (Vd/F)

  Up to End of Study (Day 112)

• Apparent Total Clearance (CL/F)

  Up to End of Study (Day 112)

Study Arms (4)

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

EXPERIMENTAL

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

Drug: JNJ-64304500; Drug: Placebo

Cohort 2: JNJ-64304500 150 mg or placebo

EXPERIMENTAL

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

Drug: JNJ-64304500; Drug: Placebo

Cohort 3: JNJ-64304500 400 mg or placebo

EXPERIMENTAL

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

Drug: JNJ-64304500; Drug: Placebo

Cohort 4: JNJ-64304500 150 mg or placebo

EXPERIMENTAL

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

Drug: JNJ-64304500; Drug: Placebo

Interventions

JNJ-64304500 DRUG

Participants will receive JNJ-64304500 as SC injection.

Cohort 1: JNJ-64304500 50 milligram (mg) or placebo; Cohort 2: JNJ-64304500 150 mg or placebo; Cohort 3: JNJ-64304500 400 mg or placebo; Cohort 4: JNJ-64304500 150 mg or placebo

Placebo DRUG

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

Cohort 1: JNJ-64304500 50 milligram (mg) or placebo; Cohort 2: JNJ-64304500 150 mg or placebo; Cohort 3: JNJ-64304500 400 mg or placebo; Cohort 4: JNJ-64304500 150 mg or placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 23, 2016
• Study Start: January 10, 2017
• Primary Completion: September 9, 2017
• Study Completion: September 9, 2017
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

JP (1)