BCD-057-5 “A double-blind comparative randomized clinical trial of the pharmacokinetics, safety, and immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira® 100 mg/mL at a single subcutaneous administration to healthy subjects”.
Over the course of the BCD-057-5 clinical trial, the comparability of pharmacokinetic parameters and similarity of safety and immunogenicity profiles of the investigational drugs, BCD-057 100 mg/mL and BCD-057 50 mg/mL, and BCD-057 100 mg/mL and Humira® 100 mg/mL, will be evaluated at a single subcutaneous administration to healthy male subjects who:
Diagnosed as “healthy”, based on the conventional clinical, laboratory and imaging methods of examination, conducted during the screening period1, according to the Clinical Investigator’s opinion, as well as medical history.
Are 18–45 years of age inclusive at the time of signing the informed consent form.
Have a BMI between 18.5-30.0 kg/m2 at the start of the screening period.
Have no experience in using adalimumab or any other tumor necrosis factor alpha (TNF-α) inhibitors2.
Have no burdened allergic history.
Have not been vaccinated with live vaccines for 4 weeks prior to randomization3, and are willing to abstain from vaccination with any vaccines for the duration of participation in the clinical trial.
Willing to comply with reliable contraceptive measures, and to refuse sperm donation and conception of a child for the period from the date of signing the informed consent form until 5 months after administration of the investigational drug4.
Are not enrolled in or have not participated in any other clinical trials within 90 calendar days prior to randomization, and agree to withdraw from participation in other clinical trials during the main period of the BCD-057-5 clinical trial5.
The BCD-057-5 clinical trial is being conducted at study centers in St. Petersburg and Moscow.
To query about participating in a clinical study, including contact details of study centers, please use a special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study, as well as about other drug products used in the study. The potential participant should read the complete study information and consult with the Clinical Investigator and/or Treating Physician.
Clinical Trial Authorization No. 82 dated February 17, 2025 of the Ministry of Health of the Russian Federation and the list of approved study centers in the territory of the Russian Federation have been published in the State Register of Medicines.
Screening is a specific period for the assessment of the possibility of a subject’s participation in the clinical trial according to the eligibility criteria based on the results of diagnostic procedures and specialists’ consultations.
Tumor necrosis factor alpha is one of the major cytokines involved in the development of diseases that are based on severe chronic inflammation.
Randomization is a procedure for assigning participants in a clinical trial to groups for the use of investigational drugs.
Investigational drug is a product manufactured for the medical use being studied or used as a reference drug in a clinical trial.
The main period of the BCD-057-5 clinical trial is a predefined period of participation in the BCD-057-5 trial from the time of investigational product dosing until clinical trial Day 71.