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

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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