drugset
drugset / Trial / NCT02731469

Study of Pharmacokinetics, Pharmacodynamics, Safety of BCD-131 Compared to Mircera and Aranesp in Healthy Volunteers

NCT02731469 ↗

Phase 1 Completed 45 enrolled Biocad
RandomizedParallel-groupOpen-labelOther

Summary

BCD-131-1 is an Open-Label Clinical Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, Safety and Immunogenicity of Single Ascending Doses of BCD-131 in Healthy Volunteers

Timeline

Start
2016-06-15
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-131 Protein / enzyme biologic 0.05 ug/kg Subcutaneous
Subject BCD-131 Protein / enzyme biologic 0.15 ug/kg Subcutaneous
Subject BCD-131 Protein / enzyme biologic 0.4 ug/kg Subcutaneous
Subject BCD-131 Protein / enzyme biologic 1.05 ug/kg Subcutaneous
Subject BCD-131 Protein / enzyme biologic 1.7 ug/kg Subcutaneous
Subject BCD-131 Protein / enzyme biologic 2.25 ug/kg Subcutaneous
Subject BCD-131 Protein / enzyme biologic 4.45 ug/kg Subcutaneous
Comparator Darbepoetin alfa Protein / enzyme biologic 0.45 ug/kg Subcutaneous
Comparator methoxy polyethylene glycol-epoetin beta Protein / enzyme biologic 1.2 ug/kg Subcutaneous

Indications

No indication recorded.