Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03103451
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03103451
Study Brief:
Protocol Section:
NCT03103451