NCT02380287

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

Open-label, Phase I Dose-escalation Clinical Study of the Safety, Tolerability and Pharmacokinetics of Single Subcutaneus Dose of BCD-085, Monoclonal Antibody Against IL-17, in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Biocad · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

IL-17 is a new potential therapeutic target which plays important role in pathogenesis of several autoimmune disorders including psoriasis, rheumatoid arthritis, possibly - SLE and MS. BCD-085 is a novel humanized monoclonal antibody against human IL17 developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-085-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics and immunogenicity of BCD-085 when used as a single step-by-step escalating subcutaneous dose in healthy male volunteers. During this study it is expected to determine diapason of safety doses of BCD-085 (incl. MTD) which thereafter can be evaluated in phase 2 studies.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	humanized monoclonal antibody against human IL-17

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-03-05
• Last updated: 2021-03-03
• Results posted: 2016-05-23