drugset / Trial / NCT02945215

A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients

NCT02945215

Phase 1 Completed 181 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma

Timeline

Start
2016-12-13
Primary completion
2019-03-21
Completion
2019-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject IBI301 Monoclonal antibody 375 mg/m2
Comparator Rituximab Monoclonal antibody 375 mg/m2

Indications