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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT02945215
Phase
PHASE1
Status
Completed

Conditions

  • B-Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • IBI301 — DRUG
    IBI301 375mg/㎡
  • Rituximab — DRUG
    Rituximab 375mg/㎡

Study Details

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

Key Dates

Start date
Dec 13, 2016
Status verified
Jun 2020
Primary completion
Mar 21, 2019
Completion
Oct 16, 2019

Study Design

Enrollment
181 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IBI301
  • Active Comparator: Rituximab

Primary Outcome Measure

AUC0-inf of IBI301 and rituximab [ Time Frame: 91 days ]

Related Studies