A Phase 1 interventional study of Ustekinumab in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Other
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.
Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single subcutaneous (SC) injection of ustekinumab in Device 1 as a reference device on Day 1.
Drug: Ustekinumab
Participants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1.
Drug: Ustekinumab
Ustekinumab will be administered as SC injection.
Also known as: CNTO1275, STELARA
Maximum Observed Serum Concentrations (Cmax) of Ustekinumab
Cmax is maximum observed serum concentration of ustekinumab.
Time frame: 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.
Time frame: Up to Day 85
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 85
Number of Participants with Antibodies to Ustekinumab
Number of participants with antibodies to ustekinumab will be reported.
Time frame: Up to Day 85
Plan to share: Yes — 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
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC