Provide Initial Evidence of Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy to Support the Pivotal CT-P10 Therapeutic Equivalence Trial

Sponsor
Celltrion
Study ID
NCT01534949
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab — BIOLOGICAL
    375 mg/m2 by intravenous \[IV\] infusion

Study Details

This study is designed to provide initial evidence of safety, pharmacokinetics, pharmacodynamics, and efficacy to support the pivotal CT-P10 therapeutic equivalence trial.

Key Dates

First listed
Feb 17, 2012
Start date
Feb 29, 2012
Status verified
Jul 2014
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CT-P10
    rituximab

Primary Outcome Measure

safety [ Time Frame: after 6 weeks of treatment begin ]

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