Healthy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGBCD-121
OTHERPlacebo
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Concentration of BCD-121 After Single Subcutaneous Injection | 90 days |
| Time to Maximum Concentration of BCD-121 After Single Subcutaneous Injection | 90 days |
Outcome results
None listed