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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275EDI1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ustekinumab (Using Reference Device) | Active Comparator | Participants will receive a single subcutaneous (SC) injection of ustekinumab in Device 1 as a reference device on Day 1. |
|
| Ustekinumab (Using Test Device) | Experimental | Participants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Ustekinumab will be administered as SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentrations (Cmax) of Ustekinumab | Cmax is maximum observed serum concentration of ustekinumab. | Up to Day 85 |
| Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinite]) | AUC (0-Infinite) defined as area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase will be evaluated. | Up to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) 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 defined as AEs with onset or worsening on or after date of first dose of study treatment. |
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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 | ||
| Celerion |
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 |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Up to Day 85 |
| Number of Participants with AEs Related to the Injection or at the Injection Site | Number of participants with AEs related to injection or at the injection site will be reported. Symptoms such as erythema, induration and pruritis that in the opinion of the investigator may be associated with the administration, will be captured as an AE (example, injection-site erythema, injection-site induration, injection-site pruritis or injection-site pain. | Up to Day 85 |
| Number of Participants with Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs (temperature [oral], pulse/heart rate, respiratory rate, and blood pressure [systolic and diastolic]) will be reported. | Up to Day 85 |
| Number of Participants with Abnormalities in Physical Examinations (PE) | Number of participants with abnormalities in physical examinations (full and brief) will be reported. Full physical examinations will include a review of the following body systems: general appearance; thorough skin and oral mucosa evaluation; eyes, ears, nose, and throat; cardiovascular; respiratory; abdomen; peripheral pulsation; lymph nodes; neurologic (including examination for muscle strength and sensory exam); musculoskeletal; head, neck, and thyroid. A brief physical examination includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area. | Up to Day 85 (for full PE) and up to Day 57 (for brief PE) |
| Number of Participants with Abnormalities in Laboratory Tests | Number of participants with abnormalities in laboratory tests (serum chemistry and hematology and urinalysis) will be reported. | Up to Day 85 |
| Number of Participants with Antibodies to Ustekinumab | Number of participants with antibodies to ustekinumab will be reported. | Up to Day 85 |
| Lincoln |
| Nebraska |
| 68502 |
| United States |
| PRA Health Sciences | Salt Lake City | Utah | 84124 | United States |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |