Healthy
Conditions
Keywords
Healthy, Guselkumab, CNTO1959, Pharmacokinetics, UltraSafe Passive Delivery System (PFS-U), Prefilled syringe facilitated injection device (PFS FID)
Brief summary
The purpose of this study is to evaluate the pharmacokinetic (what the body does to the medication) comparability of guselkumab in lyophilized and liquid formulations. Also to evaluate pharmacokinetic comparability of liquid formulation of guselkumab when delivered as prefilled syringe with UltraSafe Passive Delivery System \[PFS-U\] or with a prefilled syringe facilitated injection device \[PFS FID\]) following a single subcutaneous (SC) administration of 100 mg guselkumab in healthy participants.
Detailed description
This is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel study (each group of participants will be treated at the same time) of guselkumab in healthy participants. Approximately 140 participants will be randomly assigned in the ratio 2:2:2:1 in to 4 treatment groups: Group 1 (SC injection of lyophilized formulation), Group 2 (subcutaneous \[SC\] injection of liquid formulation with PFS-U), Group 3 (SC injection of liquid formulation with PFS-FID), and Group 4 (IV infusion of liquid formulation). The study consists of 3 phases: screening (up to 4 weeks), open-label treatment and inpatient follow up (1 week) and outpatient follow up (11 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, injection-site reactions, and clinical laboratory tests. The total duration of the study for each participant will be approximately 16 weeks.
Interventions
DRUGGuselkumab (liquid formulation with PFS-U)
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.
DRUGGuselkumab (lyophilized formulation)
Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.
DRUGGuselkumab (liquid formulation with PFS FID)
Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.
DRUGGuselkumab (liquid formulation)
Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participant with no clinically significant abnormalities * Have a weight in the range of 60 kg to 90 kg for male participants; have a weight in the range of 50 kg to 80 kg for female participants * Have a body mass index (BMI) of 18.5 kg/m2 to 29.0 kg/m2 * Agrees to protocol-defined use of effective contraception
Exclusion criteria
* Participant has a history of any clinically significant medical illness including liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, ophthalmological disorders, neoplastic disease, urinary tract diseases, or dermatological disease * Currently have any known malignancy or have a history of malignancy * Participant has a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins to monoclonal antibodies or antibody fragments * Have had a Bacillus Calmette-Guérin (BCG) vaccination within 12 months of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax) of guselkumab | Day 1 through Week 12 |
| Area under the curve (AUC) from time 0 to 70 days of guselkumab | Day 1 through Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute bioavailability of guselkumab | Day 1 through Week 12 | Bioavailability will be evaluated by using formula: AUC from time zero to infinity with extrapolation of the terminal phase of SC injection divided by AUC from time zero to infinity with extrapolation of the terminal phase of IV infusion of guselkumab and multiplied by 100. |
| Immunogenicity of guselkumab | Day 1 through Week 12 | Plasma levels of antibodies to guselkumab for evaluation of potential immunogenicity. |
| Number of participants with adverse events as a measure of safety and tolerability | Up to 12 weeks | — |
Countries
United States
Outcome results
None listed