clinical trial · NCT03157635
Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria
Hoffmann-La Roche·phase2·active not recruiting·n = 59
Paroxysmal Hemoglobinuria, NocturnalCrovalimabPlacebo
brief summary
This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be evaluated in healthy volunteers (HV) during part 1. The safety, tolerability, PK and PD of multiple doses of crovalimab will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) in parts 2, 3, 4, and OLE of the study. Efficacy of crovalimab will be evaluated in Parts 2, 3, and 4.
started
Nov 14, 2016
primary completion
Sep 30, 2026
completion
Sep 30, 2026
last updated
Feb 17, 2026
official title
An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol