HealthyPhase 1NCT02570373
A Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Participants
A Phase 1 study testing Guselkumab in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2015to 12 Jan 2016
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be a healthy man or woman with no clinically significant abnormalities on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening
- Participants must be otherwise healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Have a weight in the range of 60.0 kilogram (kg) to 100.0 kg, inclusive, if male; have a weight in the range of 50.0 kg to 90.0 kg, inclusive, if female. Have a body mass index of 18.5 kilogram per meter^2 (kg/m^2) to 30.0 kg/m^2, inclusive
- A woman must have a negative serum (beta human chorionic gonadotropin [beta hCG]) test at Screening and on Day -1
- Before drug administration, a woman must be either not of childbearing potential (Not of childbearing potential: Premenarchal; postmenopausal (greater than 45 years of age with amenorrhea for at least 12 months, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 international Units/ Liter); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy) OR of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies (established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence [when this is in line with the preferred and usual lifestyle of the participant])
Who cannot join
- Participant currently has or has a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Participant is currently undergoing or has previously undergone allergy immunotherapy for a history of anaphylactic reactions
- Participant has had major surgery (eg, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study (16 weeks)
- Participant has previously received guselkumab
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives (whichever is longer) before the study drug administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-label, Single-dose Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Subjects
The purpose of this study is to characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants.
Read the detailed description
This is an open-label single-dose study in healthy participants. All participants will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. After the administration of study drug on Day 1, participants will stay in the clinical study unit until being discharged after the assessments on Day 2. Participants will be required to return to the study center for outpatient visits including safety assessments through Day 85 after study drug administration. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Guselkumab
- Keywords
- Healthy, Guselkumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab | Experimental | Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rate of Elimination of Guselkumab Glycoform Variants Following a Single IV Administration of Guselkumab at a 10 mg/kg Dose in Healthy Participants
The composition of the glycoforms will be quantified and evaluated over time.
Measured: Up to 43 days
Secondary outcomes (1)
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO1959
Participant incidence of treatment-emergent adverse events, vital signs, physical examinations, laboratory safety tests, and 12-lead electrocardiograms (ECG).
Measured: up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start25 Sep 2015
- Primary completion12 Jan 2016
- Study completion12 Jan 2016
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02570373
- Sponsor's protocol ID
- CR107879
- Other IDs
- CNTO1959NAP1002
- Status last verified
- Jan 2025
- First submitted
- 16 Sep 2015
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
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
- Phase 1, Open-label, Single-dose Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02570373
- Acronym / sponsor ID
- CR107879
- Conditions
- Healthy
- Keywords
- Healthy, Guselkumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2015 (actual)
- Primary completion
- 12 Jan 2016 (actual)
- Study completion
- 12 Jan 2016 (actual)
- First posted
- 7 Oct 2015 (estimated)
- 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 characterize the elimination of guselkumab glycoform variants following a single intravenous (IV) administration of guselkumab at a 10 milligram per kilogram (mg/kg) dose in healthy participants.
Detailed description
This is an open-label single-dose study in healthy participants. All participants will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. After the administration of study drug on Day 1, participants will stay in the clinical study unit until being discharged after the assessments on Day 2. Participants will be required to return to the study center for outpatient visits including safety assessments through Day 85 after study drug administration. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guselkumab | Experimental | Drug: GuselkumabParticipant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be a healthy man or woman with no clinically significant abnormalities on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening
- Participants must be otherwise healthy on the basis of clinical laboratory tests performed at Screening. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- Have a weight in the range of 60.0 kilogram (kg) to 100.0 kg, inclusive, if male; have a weight in the range of 50.0 kg to 90.0 kg, inclusive, if female. Have a body mass index of 18.5 kilogram per meter^2 (kg/m^2) to 30.0 kg/m^2, inclusive
- A woman must have a negative serum (beta human chorionic gonadotropin [beta hCG]) test at Screening and on Day -1
- Before drug administration, a woman must be either not of childbearing potential (Not of childbearing potential: Premenarchal; postmenopausal (greater than 45 years of age with amenorrhea for at least 12 months, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 international Units/ Liter); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy) OR of childbearing potential and practicing a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies (established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner should be the sole partner for that participant); true abstinence [when this is in line with the preferred and usual lifestyle of the participant])
Key exclusion criteria (5 listed)
- Participant currently has or has a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Participant is currently undergoing or has previously undergone allergy immunotherapy for a history of anaphylactic reactions
- Participant has had major surgery (eg, requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study (16 weeks)
- Participant has previously received guselkumab
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months or 5 half-lives (whichever is longer) before the study drug administration
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 |
|---|---|---|
| GuselkumabParticipant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1. | Drug | Guselkumab |
Primary outcome
Change in Rate of Elimination of Guselkumab Glycoform Variants Following a Single IV Administration of Guselkumab at a 10 mg/kg Dose in Healthy Participants
Time frame: Up to 43 days
The composition of the glycoforms will be quantified and evaluated over time.
1 secondary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO1959
Time frame: up to 85 days
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.
- Phase 1, Open-label, Single-dose Study to Characterize the Elimination of Guselkumab Glycoform Variants in Healthy SubjectsLink provided by the sponsor.
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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
1 site in 1 country: 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 1 site 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 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 1 site 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?
Change in Rate of Elimination of Guselkumab Glycoform Variants Following a Single IV Administration of Guselkumab at a 10 mg/kg Dose in Healthy Participants (time frame: Up to 43 days). 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.