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:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 1:13 AM
NCT ID:
NCT05738993
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent;
* Men aged 18-45 years;
* Body mass index (BMI) in the range of 18.5 30.0 kg/m2;
* The confirmed "healthy" status;
* Left ventricular ejection fraction (LVEF) \> 50 % based on the results of EchoCG at screening;
* Willingness of the volunteers and their sexual partners of childbearing potential to use reliable methods of contraception, starting from signing the informed consent form, during the study, and for 6 months after the drug administration;
Exclusion Criteria:
* Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the study drugs;
* Values of standard laboratory and instrumental parameters exceeding the normal limits accepted at the study site;
* History or evidence of any chronic disease
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05738993
Study Brief:
Protocol Section:
NCT05738993