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Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood

Systemic Lupus Erythematosus Clinical Trial

Official title:
An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects

Clinical Trial Summary

To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02306629
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 1
Start date November 2014
Completion date April 2015
View Details
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