drugset / Trial / NCT02306629
Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
Phase 1
Completed
42 enrolled
UCB Biopharma S.P.R.L.
ACM Global Laboratories · collabEurofins · collabPharmaceutical Research Associates · collabRichmond Pharmacology Limited · collabThe Doctors Laboratory Ltd · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-04
- Completion
- 2015-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Epratuzumab | Monoclonal antibody | — | Subcutaneous |