- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04816513
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
February 22, 2022 updated by: Janssen Research & Development, LLC
An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of Ustekinumab Following a Single Subcutaneous Administration by Two Different Injection Devices in Healthy Participants
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Tempe, Arizona, United States, 85283
- Celerion
-
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Nebraska
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Lincoln, Nebraska, United States, 68502
- Celerion
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Utah
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Salt Lake City, Utah, United States, 84124
- PRA Health Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be a non-user or a light user of tobacco products (not smoke more than 10 cigarettes or equivalent a day for at least 6 months prior to screening), including all nicotine use, example, cigarettes (including e-cigarettes or the equivalent of e-cigarettes), cigars, chewing tobacco, patch, gum
- Body weight within the range of 50.0 kilograms (kg) to 90.0 kg, inclusive and body mass index within the range of 18 kilograms per meter square (kg/m^2) to 30 kg/m^2 (inclusive)
- A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
- A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 12 weeks after study intervention
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 12 weeks after receiving the last dose of study intervention
Exclusion Criteria:
- History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurologic or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- History of malignancy before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Has previously received ustekinumab
- Received an investigational intervention (including investigational vaccines or devices) or used an invasive investigational device within 30 days or 5 half lives before screening or is currently enrolled in an investigational study
- Has a current chronic infection, prior history of recurrent infection, or an active infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ustekinumab (Using Reference Device)
Participants will receive a single subcutaneous (SC) injection of ustekinumab in Device 1 as a reference device on Day 1.
|
Ustekinumab will be administered as SC injection.
Other Names:
|
Experimental: Ustekinumab (Using Test Device)
Participants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1.
|
Ustekinumab will be administered as SC injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Serum Concentrations (Cmax) of Ustekinumab
Time Frame: Up to Day 85
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Cmax is maximum observed serum concentration of ustekinumab.
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Up to Day 85
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Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinite])
Time Frame: Up to Day 85
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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.
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Up to Day 85
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Day 85
|
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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Up to Day 85
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Number of Participants with AEs Related to the Injection or at the Injection Site
Time Frame: Up to Day 85
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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.
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Up to Day 85
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Number of Participants with Abnormalities in Vital Signs
Time Frame: Up to Day 85
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Number of participants with abnormalities in vital signs (temperature [oral], pulse/heart rate, respiratory rate, and blood pressure [systolic and diastolic]) will be reported.
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Up to Day 85
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Number of Participants with Abnormalities in Physical Examinations (PE)
Time Frame: Up to Day 85 (for full PE) and up to Day 57 (for brief PE)
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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.
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Up to Day 85 (for full PE) and up to Day 57 (for brief PE)
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Number of Participants with Abnormalities in Laboratory Tests
Time Frame: Up to Day 85
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Number of participants with abnormalities in laboratory tests (serum chemistry and hematology and urinalysis) will be reported.
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Up to Day 85
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Number of Participants with Antibodies to Ustekinumab
Time Frame: Up to Day 85
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Number of participants with antibodies to ustekinumab will be reported.
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Up to Day 85
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 14, 2021
Primary Completion (Actual)
January 7, 2022
Study Completion (Actual)
January 26, 2022
Study Registration Dates
First Submitted
March 24, 2021
First Submitted That Met QC Criteria
March 24, 2021
First Posted (Actual)
March 25, 2021
Study Record Updates
Last Update Posted (Actual)
February 23, 2022
Last Update Submitted That Met QC Criteria
February 22, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108948
- CNTO1275EDI1001 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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