HealthyPhase 1NCT04816513
A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants
A Phase 1 study testing Ustekinumab in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Apr 2021to 26 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Celerion
Lincoln, Nebraska, 68502
PRA Health Sciences
Salt Lake City, Utah, 84124
Celerion
Tempe, Arizona, 85283
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Ustekinumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called CNTO1275, STELARA
Ustekinumab will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ustekinumab |
| Ustekinumab (Using Test Device) | Experimental | Participants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentrations (Cmax) of Ustekinumab
Cmax is maximum observed serum concentration of ustekinumab.
Measured: 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.
Measured: Up to Day 85
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 85
Number of Participants with Antibodies to Ustekinumab
Number of participants with antibodies to ustekinumab will be reported.
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start14 Apr 2021
- Primary completion7 Jan 2022
- Study completion26 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816513
- Sponsor's protocol ID
- CR108948
- Other IDs
- CNTO1275EDI1001
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04816513
- Acronym / sponsor ID
- CR108948
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 7 Jan 2022 (actual)
- Study completion
- 26 Jan 2022 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ustekinumab (Using Reference Device) | Active comparator | Drug: UstekinumabParticipants will receive a single subcutaneous (SC) injection of ustekinumab in Device 1 as a reference device on Day 1. |
| Ustekinumab (Using Test Device) | Experimental | Drug: UstekinumabParticipants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: CNTO1275, STELARAUstekinumab will be administered as SC injection. | Drug | Ustekinumab (Using Reference Device), Ustekinumab (Using Test Device) |
Primary outcome
Maximum Observed Serum Concentrations (Cmax) of Ustekinumab
Time frame: Up to Day 85
Cmax is maximum observed serum concentration of ustekinumab.
Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinite])
Time frame: Up to Day 85
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.
6 secondary outcomes
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 85
Number of Participants with AEs Related to the Injection or at the Injection Site
Time frame: Up to Day 85
Number of Participants with Abnormalities in Vital Signs
Time frame: Up to Day 85
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)
Number of Participants with Abnormalities in Laboratory Tests
Time frame: Up to Day 85
Number of Participants with Antibodies to Ustekinumab
Time frame: Up to Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ustekinumab in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Serum Concentrations (Cmax) of Ustekinumab (time frame: Up to Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.