Status:
COMPLETED
A Study to Assess the Pharmacokinetic Comparability of Guselkumab (CNTO1959) When Delivered by 2 Different Devices and as 2 Formulations in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
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 sam...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 9 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2013
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01866007
Start Date
May 9 2013
End Date
October 9 2013
Last Update
January 27 2020
Active Locations (3)
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1
Tempe, Arizona, United States
2
Lincoln, Nebraska, United States
3
Neptune City, New Jersey, United States