Status:
ACTIVE_NOT_RECRUITING
A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers
Lead Sponsor:
AO GENERIUM
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics of the solution form of Complarate and Actemra® in healthy volunteers. Participants received a single...
Detailed Description
Complarate (tocilizumab, solution) is being developed as a biosimilar to the drug Actemra®, a solution for subcutaneous injection. Tocilizumab is a recombinant humanized monoclonal antibody to the hu...
Eligibility Criteria
Inclusion
- Written informed consent to participate in the study;
- Men and women aged 18 to 45 years, inclusive, at the time of signing the informed consent form;
- Verified diagnosis "healthy" (based on a detailed medical history, in the absence of deviations from normal values during a physical examination, assessment of vital signs, as well as according to laboratory tests, electrocardiography and digital fluorography/digital pulmonary radiography);
- Body weight from 50.0 to 90.0 kg, inclusive; body mass index from 18.5 to 29.9 kg/m2, inclusive;
- Volunteer's agreement to adhere to adequate methods of contraception for 3 months after administration of the study or reference drug;
- The volunteer's consent not to become a donor of blood and/or its components during the entire study and for 30 days after its completion.
Exclusion
- Hypersensitivity to any of the components of the study or reference drug; a history of allergic reactions requiring drug treatment;
- Any history of tocilizumab use; use of tumor necrosis factor-alfa (TNF-alpha) inhibitors less than 3 months before randomization;
- The presence of acute and chronic diseases of the cardiovascular system, respiratory system, nervous, immune and endocrine systems, gastrointestinal tract, liver and biliary tract, kidneys and urinary tract, blood and lymphatic system, mental illness, tuberculosis;
- History of an autoimmune disease;
- History of cancer;
- Acute infectious diseases that resolved less than 28 days before randomization;
- Use of prescription medications less than 28 days or 5 half-lives of the drug (whichever is longer) or systematic use of over-the-counter medications/dietary supplements less than 14 days before randomization;
- Blood donation or blood loss (450 ml of blood or more) less than 3 months before randomization and/or planned blood donation in any quantity during participation in the study;
- Participation in clinical trials of medicinal products less than 3 months or 5 half-lives of the study drug (whichever is longer) before randomization in this study;
- Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol) or information about a history of alcoholism, drug addiction, or drug abuse;
- Positive test for the presence of alcohol in exhaled air;
- Positive urine test for the content of narcotic and potent drugs;
- Positive test for hepatitis B or C, HIV or syphilis;
- Any surgical interventions planned during the period of participation in the study;
- Depot injections or use of implants of any other drugs less than 3 months before randomization;
- Immunization with any vaccine less than 3 months before randomization;
- Special lifestyle (work at night);
- Pregnancy or breastfeeding period;
- Unwillingness or inability to comply with the recommendations prescribed by this protocol;
- Other reasons that, in the opinion of the investigator and/or Sponsor, prevent the volunteer from participating in the study or create an unreasonable risk.
Key Trial Info
Start Date :
June 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT06488521
Start Date
June 20 2024
End Date
September 30 2025
Last Update
July 30 2025
Active Locations (3)
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1
State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"
Moscow, Moscow, Russia, 117556
2
Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov Ministry of Health of Russia
Moscow, Moscow, Russia, 119435
3
LLC "X Seven Clinical Research"
Saint Petersburg, Sankt-Peterburg, Russia, 194156