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| ID | Type | Description | Link |
|---|---|---|---|
| 64304500CRD1001 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-64304500 | Drug | Participants will receive JNJ-64304500 as SC injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to End of Study (Day 112) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | The Cmax is the maximum observed serum analyte concentration. | Up to End of Study (Day 112) |
| Time to Reach Maximum Observed Serum Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
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| Placebo | Drug | Participants will receive matching placebo to JNJ-64304500 as SC injection. |
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
| Up to End of Study (Day 112) |
| Elimination Half-Life (t1/2) | Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z). | Up to End of Study (Day 112) |
| Apparent Volume of Distribution (Vd/F) | The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)]. | Up to End of Study (Day 112) |
| Apparent Total Clearance (CL/F) | The CL/F is defined as Dose/AUC (0-infinity). | Up to End of Study (Day 112) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) | The AUC (0-last) is the area under the serum concentration-time curve from time zero to last quantifiable time. | Up to End of Study (Day 112) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) | 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. | Up to End of Study (Day 112) |
| Antibodies to JNJ-64304500 | Serum samples will be collected and screened for antibodies binding to JNJ-64304500 and the titer of confirmed positive samples will be reported. | Up to End of Study (Day 112) |
| Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500 | 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. | Up to End of Study (Day 112) |