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Bioequivalence of Guselkumab IV Formulations (PFS-U vs FVP)
NCT04617691Phase 1Completed
- Sponsor
- Janssen Pharmaceutical
- Start
- Nov 2020
- Primary completion
- Jul 2021
- Modality
- Monoclonal Antibodies
- Countries
- 1
01
Overview
Phase 1, randomised, open-label trial of guselkumab in Crohn's disease and ulcerative colitis (UC) (2 arms), sponsored by Janssen Pharmaceutical. Primary endpoints: Maximum Observed Serum Concentration and Area Under The Serum Concentration Versus Time Curve From Time 0 to Infinity. Started Nov 2020; status: completed.
02
Drugs
guselkumab
03
Conditions
Crohn's diseaseulcerative colitis (UC)
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