Trial intelligence / Profile preview

PK of Pozelimab Process A vs Process B in Healthy Adults

NCT04491838Phase 1Completed

Sponsor
Regeneron Pharmaceuticals
Start
Aug 2020
Primary completion
Mar 2021
Modality
Recombinant Proteins and Enzymes, Monoclonal Antibodies
Countries
1
01

Overview

Phase 1, randomised, open-label trial of pozelimab in CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathy, paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and 1 more (2 arms), sponsored by Regeneron Pharmaceuticals. Primary endpoints: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration up to 16 weeks and Peak Plasma Concentration up to 16 weeks. Started Aug 2020; status: completed.

02

Drugs

pozelimab
03

Conditions

CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathyparoxysmal nocturnal hemoglobinuria (PNH)atypical hemolytic uremic syndrome (aHUS)myasthenia gravis (MG)

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