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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959NAP1002 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants.
This is an open-label single-dose study in healthy participants. All participants will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. After the administration of study drug on Day 1, participants will stay in the clinical study unit until being discharged after the assessments on Day 2. Participants will be required to return to the study center for outpatient visits including safety assessments through Day 85 after study drug administration. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guselkumab | Experimental | Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rate of Elimination of Guselkumab Glycoform Variants Following a Single IV Administration of Guselkumab at a 10 mg/kg Dose in Healthy Participants | The composition of the glycoforms will be quantified and evaluated over time. | Up to 43 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO1959 | Participant incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECG). | up to 85 days |
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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 |
|---|---|---|---|---|---|---|
| Tempe | Arizona | United States |
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| Label | URL |
|---|---|
| Phase 1, Open-label, Single-dose Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Subjects | View source |
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| ID | Term |
|---|---|
| C000588857 | guselkumab |
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