HealthyPhase 1NCT04147338
A Study of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
A Phase 1 study testing Guselkumab in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Guselkumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Oct 2019to 7 Dec 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive
- Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening and Day -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
- Contraceptive (birth control) use by men should be consistent with local regulations (if any) regarding the acceptable methods of contraception for those participating in clinical studies
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after 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 (GI) 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 a current chronic infection, prior history of recurrent infection, or an active infection
- Has previously received guselkumab
- Has a positive urine drug and alcohol screen during screening or at admission (Day -1)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-label, Randomized, Parallel-group Study to Assess the Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
The purpose of this study is to evaluate the serum concentration of guselkumab after administration using three different devices in healthy participants.
- Conditions
- Healthy
- Being tested
- Guselkumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Also called CNTO 1959
Guselkumab will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Reference Device: Guselkumab | Experimental | Participants will receive subcutaneous (SC) injections of guselkumab in reference device. Receives: Drug: Guselkumab |
| Test Device 1: Guselkumab | Experimental | Participants will receive SC injections of guselkumab in test device 1. Receives: Drug: Guselkumab |
| Test Device 2: Guselkumab | Experimental | Participants will receive SC injections of guselkumab in test device 2. Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Cmax is the maximum observed serum concentration.
Measured: Up to Day 85
Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity])
AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
Measured: Up to Day 85
Secondary outcomes (5)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
An adverse event 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 AEs which will occur up to 113 days that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Up to 113 days
Number of Participants with Clinically Significant Vital Signs Abnormalities
Number of participants with clinically significant abnormalities in the vital signs including temperature (oral), pulse rate, respiratory rate, and blood pressure will be reported.
Measured: Up to 113 days
Number of Participants with Clinically Significant Physical Examination Abnormalities
Number of participants with clinically significant abnormalities in the physical examination (includes basic assessment of general appearance, respiratory and cardiovascular systems and the assessment of the skin at the administration area) will be reported.
Measured: Up to 113 days
Number of Participants with Clinically Significant Laboratory Abnormalities
Number of participants with clinically significant abnormalities in laboratory assessments like serum chemistry, hematology, and urinalysis will be reported.
Measured: Up to 113 days
Number of Participants with Anti-Guselkumab Antibodies
Number of participants with anti-drug antibodies to guselkumab 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 posted1 Nov 2019
- Study start30 Oct 2019
- Primary completion13 Sep 2021
- Study completion7 Dec 2021
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
- 440 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
- NCT04147338
- Sponsor's protocol ID
- CR108698
- Other IDs
- CNTO1959CRD1003, 2020-003725-32
- Status last verified
- Jan 2025
- First submitted
- 30 Oct 2019
- Last updated
- 3 Feb 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 3 Feb 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 Pharmacokinetic Bioequivalence of Subcutaneously-administered Guselkumab Delivered by 3 Different Devices in Healthy Participants
- ClinicalTrials.gov ID
- NCT04147338
- Acronym / sponsor ID
- CR108698
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 13 Sep 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 1 Nov 2019 (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 serum concentration of guselkumab after administration using three different devices in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference Device: Guselkumab | Experimental | Drug: GuselkumabParticipants will receive subcutaneous (SC) injections of guselkumab in reference device. |
| Test Device 1: Guselkumab | Experimental | Drug: GuselkumabParticipants will receive SC injections of guselkumab in test device 1. |
| Test Device 2: Guselkumab | Experimental | Drug: GuselkumabParticipants will receive SC injections of guselkumab in test device 2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a weight in the range of 50.0 kilogram (kg) to 90.0 kg, inclusive
- Be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening and Day -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
- A female participant must have a negative pregnancy test result at screening and baseline (Day -1) and while enrolled in this study
- Contraceptive (birth control) use by men should be consistent with local regulations (if any) regarding the acceptable methods of contraception for those participating in clinical studies
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 12 weeks after 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 (GI) 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 a current chronic infection, prior history of recurrent infection, or an active infection
- Has previously received guselkumab
- Has a positive urine drug and alcohol screen during screening or at admission (Day -1)
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 |
|---|---|---|
| GuselkumabAlso: CNTO 1959Guselkumab will be administered subcutaneously. | Drug | Reference Device: Guselkumab, Test Device 1: Guselkumab, Test Device 2: Guselkumab |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: Up to Day 85
Cmax is the maximum observed serum concentration.
Area Under the Serum Concentration-Time Curve from Time Zero to Time Infinity (AUC [0-infinity])
Time frame: Up to Day 85
AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the serum concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
5 secondary outcomes
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 113 days
Number of Participants with Clinically Significant Vital Signs Abnormalities
Time frame: Up to 113 days
Number of Participants with Clinically Significant Physical Examination Abnormalities
Time frame: Up to 113 days
Number of Participants with Clinically Significant Laboratory Abnormalities
Time frame: Up to 113 days
Number of Participants with Anti-Guselkumab Antibodies
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 3 Feb 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
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Guselkumab in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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 Concentration (Cmax) (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 3 Feb 2025.