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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959EDI1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed Product (FVP) (IV) to create the IV solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Guselkumab PFS-U | Experimental | Participants will receive single intravenous (IV) guselkumab formulation using UltraSafe Plus Passive Needle Guards (PFS-U) to create the IV solution. |
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| Group 2: Guselkumab FVP | Experimental | Participants will receive single IV guselkumab formulation using Final Vialed Product (FVP) to create the IV solution. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered as IV solution derived from FVP or PFS-U. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Cmax is defined as maximum observed serum concentration. | Up to Day 85 |
| Area Under The Serum Concentration Versus Time Curve From Time 0 to Infinity Based on Extrapolation of The Terminal Phase (AUC[0-infinity]) | AUC(0-infinity) is defined as area under the serum concentration vs time curve from time 0 to infinity based on extrapolation of the terminal phase. | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Day 85 |
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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 |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Berlin GmbH | Berlin | 13353 | Germany |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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| Percentage of Participants with Serious Adverse Events (SAEs) | A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Day 85 |
| Percentage of Participants with Clinically Significant Changes in Vital Signs | Percentage of participants with clinically significant changes in vital signs (including temperature (oral), pulse/heart rate, respiratory rate, and blood pressure) will be reported. | Up to Day 85 |
| Percentage of Participants with Clinically Significant Changes in Physical Examinations | Percentage of participants with clinically significant changes in physical examinations (including general appearance, respiratory, cardiovascular, assessment of the skin at or around the intravenous [IV] administration area) will be reported. | Up to Day 85 |
| Percentage of Participants with Clinically Significant Changes in Laboratory Safety Tests | Percentage of participants with clinically significant changes in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported. | Up to Day 85 |
| Percentage of Participants with Antibodies to Guselkumab | Percentage of participants with antibodies to guselkumab will be reported. | Up to Day 85 |