Trials / Completed
CompletedNCT02945215
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
A Multicenter, Randomized, Double-blinded, Parallel Controlled 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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 181 (actual)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IBI301 | IBI301 375mg/㎡ |
| DRUG | Rituximab | Rituximab 375mg/㎡ |
Timeline
- Start date
- 2016-12-13
- Primary completion
- 2019-03-21
- Completion
- 2019-10-16
- First posted
- 2016-10-26
- Last updated
- 2020-09-01
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02945215. Inclusion in this directory is not an endorsement.