drugset
drugset / Trial / NCT02380287

First-in-human Study to Evaluate Safety, Tolerability and Pharmacokinetics of Various Doses of BCD-085 in Healthy Subjects

NCT02380287 ↗

Phase 1 Completed 22 enrolled Biocad
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open label, phase 1, "3+3" dose escalating study of tolerability, safety, pharmacokinetics and immunogenicity of a single subcutaneous injection of the novel monoclonal antibody against human IL-17 - BCD-085. The study will enroll 37 healthy male volunteers.

Timeline

Start
2015-03
Primary completion
2015-09
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BCD-085 Monoclonal antibody 0.05 mg/kg Subcutaneous
Subject BCD-085 Monoclonal antibody 0.25 mg/kg Subcutaneous
Subject BCD-085 Monoclonal antibody 0.825 mg/kg Subcutaneous
Subject BCD-085 Monoclonal antibody 1.25 mg/kg Subcutaneous
Subject BCD-085 Monoclonal antibody 1.75 mg/kg Subcutaneous
Subject BCD-085 Monoclonal antibody 2.25 mg/kg Subcutaneous
Subject BCD-085 Monoclonal antibody 3 mg/kg Subcutaneous

Indications

No indication recorded.