drugset / Trial / NCT04617691
A Study of Intravenous Formulation of Guselkumab Using Prefilled Syringes and Final Vialed Product in Healthy Participants
RandomizedParallel-groupOpen-labelOther
Summary
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.
Timeline
- Start
- 2020-11-30
- Primary completion
- 2021-07-20
- Completion
- 2021-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Guselkumab | Monoclonal antibody | — | Intravenous |
Indications
No indication recorded.