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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959NAP1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System [PFS-U] or with a prefilled syringe facilitated injection device [PFS FID]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous [SC] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 40 participants will receive a single subcutaneous (SC) injection of 100 mg guselkumab prepared from lyophilized formulation. |
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| Group 2 | Experimental | 40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with UltraSafe Passive Delivery System (PFS-U). |
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| Group 3 | Experimental | 40 participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with a prefilled syringe facilitated injection device (PFS FID). |
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| Group 4 | Experimental | 20 participants will receive a single intravenous (IV) infusion of 100 mg guselkumab prepared from liquid formulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab (lyophilized formulation) | Drug | Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of guselkumab | Day 1 through Week 12 | |
| Area under the curve (AUC) from time 0 to 70 days of guselkumab | Day 1 through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability of guselkumab | Bioavailability will be evaluated by using 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 guselkumab and multiplied by 100. | Day 1 through Week 12 |
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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, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO 1959) Delivered by 2 Different Devices in Healthy Subjects | View source |
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| Guselkumab (liquid formulation with PFS-U) | Drug | Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U. |
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| Guselkumab (liquid formulation with PFS FID) | Drug | Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID. |
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| Guselkumab (liquid formulation) | Drug | Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation. |
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| Immunogenicity of guselkumab |
Plasma levels of antibodies to guselkumab for evaluation of potential immunogenicity. |
| Day 1 through Week 12 |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 12 weeks |
| Lincoln |
| Nebraska |
| United States |
| Neptune City | New Jersey | United States |
| ID | Term |
|---|---|
| C000588857 | guselkumab |
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