BCD-017-4 “An open-label comparative study of safety, pharmacodynamics, pharmacokinetics, and immunogenicity of BCD-017 after a single administration in escalating doses to healthy volunteers compared to filgrastim”.
During the BCD-017-4 clinical trial, the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity (IG) of BCD-017 after a single administration in escalating doses to healthy volunteers will be evaluated compared to filgrastim who:
Are between 18 and 45 years of age, inclusive, at the time of signing the informed consent form;
Are determined to be healthy based on medical history and standard clinical, laboratory, and instrumental examinations conducted during the screening period1, as assessed by the investigator;
Are willing to use reliable contraceptive measures from the time of signing the informed consent form, throughout the study, and for one month after receiving the investigational drug product.
Have not had infectious mononucleosis within two months prior to the start of screening;
Have no hypersensitivity (allergies) to the compound of BCD-017/filgrastim;
Have a body mass index (BMI) between 18.0 and 30.0 kg/m2 at the time of the screening examination;
Have not participated in any other clinical trials within three months prior to signing the informed consent form and agree to refrain from participating in other clinical trials throughout the study.
The BCD-017-4 clinical trial is being conducted at study centers in various cities across the Russian Federation, including Smolensk and Perm.
You can ask questions about participating in the clinical trial, including clarifying contact information for the study sites, through a special form on the website ct.biocad.ru.
The investigator will explain the other eligibility criteria and contraindications for participation in this clinical trial to the potential participant. A potential participant should review the complete information about the study and consult with the investigator and/or their treating physician.
The Permit of the Ministry of Health of the Russian Federation for conducting this clinical trial, No. 280 dated June 26, 2024, and the list of approved study sites have been published in the State Register of Medicinal Products.
Screening is a specific period for assessing a subject’s eligibility for participation in the clinical trial based on diagnostic procedures and consultations with specialists.