Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNTO136NAP1003 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the bioavailability (the extent to which a medication becomes available to the body) of subcutaneously (under the skin using a needle) administered sirukumab and to compare the pharmacokinetics of sirukumab administered subcutaneously using a pre-filled syringe fitted with the UltraSafe Passiveâ„¢ Delivery system (PFS-U) with the SmartJectâ„¢ Autoinjector (PFS-AI) in healthy male participants.
This is a randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group (each group of participants will be treated at the same time), multicenter; single-dose study. Approximately 138 participants will be randomly allocated in a 3:3:3:7:7 ratio to 1 of the 5 treatment groups as follows: Group 1 (a single intravenous infusion of 100 mg sirukumab), Group 2 (a single subcutaneous [SC] injection of 50 mg sirukumab with PFS-U), Group 3 (a single SC injection of 50 mg sirukumab with PFS-AI, Group 4 (a single SC injection of 100 mg sirukumab with PFS-U), and Group 5 (a single SC injection of 100 mg sirukumab with PFS-AI). Randomization will be stratified by body weight (50.0 kg to <70.0 kg, 70.0 kg to <85.0 kg, 85.0 kg to 100.0 kg). Participants will be hospitalized in the study unit for administration of study drug and will be discharged after completion of all scheduled assessments on Day 5. Participants will be required to return to the study unit for outpatient visits on Days 6 and 7, followed by weekly/biweekly outpatient visits, and then a safety follow-up for a total of 13 weeks after study drug administration. Safety evaluations will include assessment of adverse events, physical examination, vital signs, injection site and infusion reactions, electrocardiogram, and clinical laboratory tests. The maximum study duration for each participant will be 120 days.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 18 participants will receive a single intravenous (IV) infusion of 100 mg sirukumab |
|
| Group 2 | Experimental | 18 participants will receive a single subcutaneous (SC) injection of 50 mg sirukumab using a Pre-filled Syringe (PFS) fitted with the UltraSafe Passiveâ„¢ Delivery System (PFS-U) |
|
| Group 3 | Experimental | 18 participants will receive a single SC injection of 50 mg sirukumab using the SmartJectâ„¢ Autoinjector (PFS-AI) |
|
| Group 4 | Experimental | 42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-U |
|
| Group 5 | Experimental | 42 participants will receive a single SC injection of 100 mg sirukumab using a PFS-AI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sirukumab (IV infusion) | Drug | Participants will receive a single IV infusion of 100 mg sirukumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability of 100 mg sirukumab administered subcutanoeusly | Bioavailability will be evaluated by using the formula: AUC from time zero to infinity with extrapolation of the terminal phase of SC injection divided by AUC from time zero to infinity with extrapolation of the terminal phase of IV infusion of sirukumab and multiplied by 100. | Up to Week 13 |
| Maximum Observed Serum Concentration (Cmax) of 100 mg sirukumab administered subcutanoeusly | The Serum Concentration (Cmax) is defined as maximum observed analyte concentration. | Up to Week 13 |
| Area Under the Serum Concentration-Time Curve From Time Zero to 77 days (AUC0-77d) of 100 mg sirukumab administered subcutanoeusly | Up to Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Up to Week 13 | |
| Immunogenicity of sirukumab | Serum levels of antibodies to sirukumab will be used to evaluate potential immunogenicity. | Up to Week 13 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sirukumab (SC injection with PFS-U) | Drug | Participants will receive a single SC injection of 50 mg sirukumab with PFS-U. |
|
| Sirukumab (SC injection with PFS-AI) | Drug | Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI. |
|
| Sirukumab (SC injection with PFS-U) | Drug | Participants will receive a single SC injection of 100 mg sirukumab with PFS-U. |
|
| Sirukumab (SC injection with PFS-AI) | Drug | Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI. |
|
| Lincoln |
| Nebraska |
| United States |
| ID | Term |
|---|---|
| C568922 | sirukumab |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |
Not provided
Not provided