CRS Clinical Research Services Berlin GmbH
Berlin, 13353, Germany
NCT Number: NCT04617691
The purpose of this study is to evaluate the bioequivalence of an intravenous (IV) administration of the guselkumab formulation using UltraSafe Plus Passive Needle Guard (PFS-U) to create the IV solution versus the guselkumab formulation using Final Vialed Product (FVP) (IV) to create the IV solution.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Berlin, 13353, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Guselkumab will be administered as IV solution derived from FVP or PFS-U.
Time frame: Up to Day 85
Cmax is defined as maximum observed serum concentration.
Time frame: Up to Day 85
AUC(0-infinity) is defined as area under the serum concentration vs time curve from time 0 to infinity based on extrapolation of the terminal phase.
Time frame: Up to Day 85
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Time frame: Up to Day 85
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Up to Day 85
Percentage of participants with clinically significant changes in vital signs (including temperature (oral), pulse/heart rate, respiratory rate, and blood pressure) will be reported.
Time frame: Up to Day 85
Percentage of participants with clinically significant changes in physical examinations (including general appearance, respiratory, cardiovascular, assessment of the skin at or around the intravenous [IV] administration area) will be reported.
Time frame: Up to Day 85
Percentage of participants with clinically significant changes in laboratory safety tests (such as serum chemistry, hematology and urinalysis) will be reported.
Time frame: Up to Day 85
Percentage of participants with antibodies to guselkumab will be reported.
Janssen Research & Development, LLC
Industry
An Open-label, Randomized, Parallel-group Study to Assess the Bioequivalence of the Intravenous Formulation of Guselkumab Using Prefilled Syringes Assembled in an UltraSafe Plus Passive Needle Guard and Intravenous Formulation of Guselkumab Using Final Vialed Product in Healthy Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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