Healthy
Conditions
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.
Interventions
DRUGJNJ-64304500
Participants will receive JNJ-64304500 as SC injection.
DRUGPlacebo
Participants will receive matching placebo to JNJ-64304500 as SC injection.
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to End of Study (Day 112) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Up to End of Study (Day 112) | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. |
| Elimination Half-Life (t1/2) | Up to End of Study (Day 112) | Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z). |
| Apparent Volume of Distribution (Vd/F) | Up to End of Study (Day 112) | The Vd/F is defined as Dose/\[Lambda (z)\*AUC (0-infinity)\]. |
| Apparent Total Clearance (CL/F) | Up to End of Study (Day 112) | The CL/F is defined as Dose/AUC (0-infinity). |
| Maximum Observed Serum Concentration (Cmax) | Up to End of Study (Day 112) | The Cmax is the maximum observed serum analyte concentration. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | Up to End of Study (Day 112) | The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. |
| Antibodies to JNJ-64304500 | Up to End of Study (Day 112) | Serum samples will be collected and screened for antibodies binding to JNJ-64304500 and the titer of confirmed positive samples will be reported. |
| Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500 | Up to End of Study (Day 112) | Percentage of NKG2D receptors on natural killer (NK) cells and cluster of differentiation 8 (CD8)+ T cells that are occupied by JNJ-64304500 will be analyzed using a validated flow cytometry assay. |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) | Up to End of Study (Day 112) | The AUC (0-last) is the area under the serum concentration-time curve from time zero to last quantifiable time. |
Countries
Japan
Outcome results
None listed