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drugset / Trial / NCT02101073

ALX-0061 Phase I Bioavailability Study in Healthy Volunteers

NCT02101073 ↗

Phase 1 Completed 70 enrolled Ablynx, a Sanofi company
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The overall aims of the study are: * To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference. * To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061. * To further determine the safety and tolerability of ALX-0061. * To further evaluate the systemic (serum) immunogenicity of ALX-0061.

Timeline

Start
2014-03-31
Primary completion
2014-07-31
Completion
2014-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Vobarilizumab Protein / enzyme biologic — Intravenous

Indications

rheumatoid arthritis