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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959CRD1003 | Other Identifier | Janssen Research & Development, LLC | |
| 2020-003725-32 | EudraCT Number |
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The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference Device: Guselkumab | Experimental | Participants will receive subcutaneous (SC) injections of guselkumab in reference device. |
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| Test Device 1: Guselkumab | Experimental | Participants will receive SC injections of guselkumab in test device 1. |
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| Test Device 2: Guselkumab | Experimental | Participants will receive SC injections of guselkumab in test device 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Guselkumab will be administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Cmax is the maximum observed serum concentration. | Up to Day 85 |
| Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity]) | AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity 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 measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant. | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur up to 113 days that were absent before treatment or that worsened relative to pre-treatment state. |
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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 | ||
| CRS Clinical Research Services |
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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| Up to 113 days |
| Number of Participants with Clinically Significant Vital Signs Abnormalities | Number of participants with clinically significant abnormalities in the vital signs including temperature (oral), pulse rate, respiratory rate, and blood pressure will be reported. | Up to 113 days |
| Number of Participants with Clinically Significant Physical Examination Abnormalities | Number of participants with clinically significant abnormalities in the physical examination (includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area) will be reported. | Up to 113 days |
| Number of Participants with Clinically Significant Laboratory Abnormalities | Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported. | Up to 113 days |
| Number of Participants with Anti-Guselkumab Antibodies | Number of participants with anti-drug antibodies to guselkumab will be reported. | Up to Day 85 |
| Mannheim |
| 68167 |
| Germany |