BCD-282-1 “A double-blind, randomized, comparative clinical study of the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of BCD-282 and the reference product after a single subcutaneous administration in healthy volunteers”.
During the BCD-282-1 clinical trial, the pharmacokinetic equivalence and comparability of the safety profile of BCD-282 and Takhzyro® will be evaluated following a single subcutaneous administration in healthy male volunteers 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;
Have a body mass index (BMI) between 18.5 and 30.0 kg/m² at the time of the screening examination;
Are willing to use reliable contraceptive measures from the time of signing the informed consent form, throughout the study, and for 3 months after receiving the investigational product. These requirements do not apply to participants who have undergone operative sterilization;
Have no remarkable history of allergies;
Have no hypersensitivity to lanadelumab or other excipients contained in the investigational drug or the Active Comparator;
Have not received any monoclonal antibody products within 6 months prior to the date of signing the informed consent form;
Have not taken any drug products orally or received parenteral administration of any drug products, including over-the-counter medications, vitamins (e.g., vitamin E), and dietary supplements (e.g., fish oil), within 14 days prior to the date of signing the informed consent form and are able to refrain from using any drug products throughout the study;
Have not participated in any other clinical trials within 3 months prior to signing the informed consent form and agree to refrain from participating in other clinical trials throughout the study.
The BCD-282-1 clinical trial is being conducted at study centers in cities across the Russian Federation, such as Tomsk and Saransk.
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 this clinical trial, No. 557, dated November 28, 2024, and the list of approved study sites have been published in the State Register of Medicines.
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.