A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 11/23/2013 |
Start Date: | May 2013 |
End Date: | September 2013 |
Email: | JNJ.CT@sylogent.com |
Phase 1, Open-label, Randomized, Parallel Study to Assess the Pharmacokinetic Comparability of 2 Formulations and to Evaluate Pharmacokinetic Comparability of Guselkumab (CNTO1959) Delivered by 2 Different Devices in Healthy Subjects
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.
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.
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
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