drugset / Trial / NCT04027803

Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®

NCT04027803

Phase 1 Completed 78 enrolled Biocad
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers

Timeline

Start
2018-09-21
Primary completion
2019-04-07
Completion
2019-04-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody 900 mg Intravenous

Indications

No indication recorded.