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

NCT02306629 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-05-12

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Epratuzumab sc

Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,

BIOLOGICAL

Epratuzumab iv

Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous,

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • ACM Global Laboratories

    collaborator OTHER

  • Eurofins

    collaborator INDUSTRY

  • The Doctors Laboratory Ltd

    collaborator INDUSTRY

  • UCB Biopharma S.P.R.L.

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02306629 on ClinicalTrials.gov