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| ID | Type | Description | Link |
|---|---|---|---|
| C0328T08 | Other Identifier | Centocor |
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The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.
This is a single-dose and randomized (study medication is assigned by chance) study. This study will be conducted in 2 parts (Part 1 and Part 2). Approximately 144 participants will be enrolled in this study (24 participants in Part 1 and 120 participants in Part 2). Part 1 is the double-blind (neither physician nor participants know the treatment that the participant receives) and staggered parallel (a clinical study comparing the response in two or more groups of participants receiving different treatments) part of the study. Participants in Part 1 will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo. Part 2 is the open-label (all people know the identity of the intervention) part of the study. Participants in Part 2 will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 199 days including a screening phase (within 30 days before the first study medication administration) and a treatment phase (inpatient [hospitalization period] 12 days and outpatient [follow-up] visits up to 169 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Participants will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo. |
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| Part 2 | Experimental | Participants will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 328 (Sp2/0-derived) | Drug | Participants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability in Part 1 | Up to Day 199 | |
| Maximum observed serum concentration (Cmax) of CNTO 328 in Part 2 | This sample will be used for pharmacokinetics analysis. Cmax is defined as the maximum observed analyte concentration. | Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85 |
| Area under the serum concentration-time curve from Day 0 to Day 84 (AUC 0-84D) of CNTO 328 in Part 2 | This sample will be used for pharmacokinetics analysis. AUC 0-84D is a measure of the serum concentration of the study medication over time. It is used to characterize drug absorption. | Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability in Part 2 | Up to Day 199 | |
| Immune response of CNTO 328 in Part 1 and Part 2 | Immune response will be evaluated by analyzing serum samples for the determination of the presence of antibodies to CNTO 328. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln | Nebraska | United States | ||||
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| CNTO 328 (CHO-derived) | Drug | Participants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2. |
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| Placebo | Drug | Participants will receive a single-dose of matching placebo intravenously in Part 1. |
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| Day 1 (predose), Days 85, 113, and 169 |
| Neptune City |
| New Jersey |
| United States |
| ID | Term |
|---|---|
| C504234 | siltuximab |
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