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| ID | Type | Description | Link |
|---|---|---|---|
| 54767414EDI1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required to improve the tolerability of SC administration of daratumumab in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daratumumab | Experimental | Participants will receive a single subcutaneous (SC) dose of daratumumab in each of first 7 dose cohorts. Doses will be escalated based on review of pharmacokinetic, pharmacodynamic, and safety data of previous cohort. Participants in Cohort 8 will receive single SC daratumumab formulation containing recombinant human hyaluronidase (rHuPH20). |
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| Placebo | Placebo Comparator | Participants will receive placebo as a single SC dose in each of first 7 cohorts. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daratumumab | Drug | Single SC dose of daratumumab will be administered in each of 8 dose cohorts. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Treatment-Emergent Adverse Event (TEAEs) by Severity Through Day 141 Versus Placebo | The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed. | Up to Day 141 |
| Proportion of Participants With TEAEs by Serious Adverse Events (SAEs) Through Day 141 Versus Placebo | The safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants will be assessed. | Up to Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is the maximum observed plasma concentration. | Day 1 predose through Day 141 |
| Time to the Maximum Observed Plasma Concentration (Tmax) | Tmax is defined as actual sampling time to reach maximum observed plasma concentration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
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| Placebo | Drug | Placebo liquid will be administered as SC dose in each of first 7 dose cohorts. |
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| rHuPH20 | Drug | Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation. |
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| Day 1 predose through Day 141 |
| Area Under the Plasma Concentration-time Curve From Time Zero to the Time Corresponding to the Last Quantifiable Serum Concentration (AUC [0-last]) | AUC (0-last) is the area under the plasma concentration-time curve from time zero to the time corresponding to the last quantifiable serum concentration. | Day 1 predose through Day 141 |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity With Extrapolation of the Terminal Phase (AUC[0- infinity]) | AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinity with extrapolation of the terminal phase, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma 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. | Day 1 predose through Day 141 |
| Number of Participants With Anti-daratumumab Antibodies | Number of participants who test positive for anti-daratumumab antibodies will be reported. | Day 1 predose through Day 141 |
| Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies | Number of participants who test positive for anti-rHuPH20 antibodies will be reported. | Day 1 predose through Day 141 |
| Percentage of CD38 Expression Levels and CD38 Expressing Cell Counts Measured by Flow Cytometry | The cluster of differentiation (CD) 38 expression levels and CD38 expressing cell counts, as measured by flow cytometry, will be summarized. | Day 1 predose through Day 141 |