drugset / Trial / NCT03912441

First-In-Human Study to Evaluate Safety And Pharmacokinetics of Single Escalating Doses of BCD-147 (Bispecific Anti-HER2/HER2 Antibody) in Healthy Subjects

NCT03912441 ↗

Phase 1 Completed 15 enrolled Biocad
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, phase 1, "3+3 trial" of pharmacokinetics, safety and immunogenicity of BCD-147 (JSC "BIOCAD", Russia) after single administration of escalating doses in healthy male volunteers

Timeline

Start
2019-01-30
Primary completion
2019-09-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-147 Monoclonal antibody — —

Indications

No indication recorded.