A Comparative Randomized Single-Blind Placebo-controlled Study of the Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Single Escalating Subcutaneous Doses of BCD 121 in Healthy Volunteers

Biocad0 个研究点目标入组 28 人开始时间: 2016年11月最近更新: 2017年7月17日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Biocad
入组人数: 28
主要终点: Area Under the Plasma Concentration of BCD-121-time Curve From Zero (0) Hours to 2160 Hours After the Single Subcutaneous Injection of BCD-121

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is an open label, phase 1, "3+3", placebo-controlled dose escalating study of tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single subcutaneous injection of the novel monoclonal bispecific antibody against human IL-17/TNFa. The study will enroll 28 healthy male volunteers.

详细描述

Simultaneous blockade of IL-17 and TNFa is a potential therapeutic way of treatment of several autoimmune disorders. BCD-121 is a novel humanized monoclonal bispecific antibody against human IL17 and TNFa developed by JCS BIOCAD (Russia) which is now on the first step of clinical evaluation. BCD-121-1 study is the first-in-human clinical trial which is intended to evaluate tolerability, safety, pharmacokinetics, pharmacodynamics and immunogenicity of BCD-121 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-121 (incl. MTD) which thereafter can be evaluated in phase 2 studies.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•singed informed consent
•male gender
•18-45 years of age inclusively
•BMI between18.5-30.0 kg/sq.m.
•absence of any sings of hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality at screening or/and in anamnesis
•parameters of complete blood count, blood biochemistry, and urinalysis do not exceed reference values, which are used at Study site laboratory
•normal hemodynamic parameters
•absence of chronic infections (HIV, syphilis, hepatitis В or С, tuberculosis ) and chronic inflammation
•absence of infections within 4 weeks before randomization
•absence of mental disorders or other conditions (incl. depression), which may affect the ability of participant to follow Protocol
•health well-being (by volunteer's opining opinion) for at least 30 days before randomization.
•absence of alcohol or drug addiction signs (incl. history of such addiction)
•volunteer's ability to follow Protocol procedures
•consent of volunteers and their sexual partners with childbearing potential to use adequate contraception

排除标准

•history of use of monoclonal antibodies against IL-17 or TNFa
•known severe allergy (anaphylaxis or multidrug intolerance)
•known intolerance to medicines containing monoclonal antibodies (murine, humanized, human) or to any excipients of BCD-121/placebo
•major surgery within 30 days prior screening
•severe infections (required hospitalization, parenteral use of antimicrobial agents)
•systemic use of antimicrobials
•more than 4 episodes of respiratory tract infections within 6 months prior the screening
•presence of any disorders which may affect pharmacokinetics of BCD-121
•history of fever which was equal or exceeded 40 degrees in Celsius
•history of hepatic transaminases increase 2.5 x ULN
•history of seizures
•actual or prior depression, suicidal tendencies
•use of any medicines, vitamins, biologically active additives within 14 days prior the date of BCD-085 injection
•use of any medicines which affects hemodynamics or hepatic function within 30 days prior the date of BCD-121 injection
•simultaneous participation in any other clinical trial, as well as former participation in other clinical trials within 3 months before this study initiation.
•previous participation in this study