drugset
drugset / Trial / NCT03103438

First-in-human Study of Safety, Pharmacokinetics and Pharmacodynamics of Various Doses of BCD-089 in Healthy Subjects

NCT03103438 ↗

Phase 1 Completed 19 enrolled Biocad
Non-randomizedFactorialOpen-labelTreatment

Summary

This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against the interleukin-6 receptor - BCD-089. The study will enroll 19 healthy male volunteers.

Timeline

Start
2016-11
Primary completion
2017-05
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Levilimab Monoclonal antibody 0.06 mg/kg Subcutaneous
Subject Levilimab Monoclonal antibody 0.3 mg/kg Subcutaneous
Subject Levilimab Monoclonal antibody 0.625 mg/kg Subcutaneous
Subject Levilimab Monoclonal antibody 1 mg/kg Subcutaneous
Subject Levilimab Monoclonal antibody 1.6 mg/kg Subcutaneous
Subject Levilimab Monoclonal antibody 2.2 mg/kg Subcutaneous
Subject Levilimab Monoclonal antibody 2.9 mg/kg Subcutaneous

Indications

No indication recorded.