Comparing the safety and pharmacokinetics of Complarate and Actemra in healthy volunteers

A Single-blind Randomized Comparative Study of the Safety and Pharmacokinetics of Complarate and Actemra® in the Form of a Solution for Subcutaneous Administration in Parallel Groups of Healthy Volunteers

This study is testing if a new drug called Complarate is as safe and works the same way as Actemra in healthy adults aged 18 to 45.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Ao Generium (Industry-sponsored)
• Drugs / interventions: tocilizumab
• Locations: 3 sites (Moscow and 2 other locations)
• Trial ID: NCT06488521 on ClinicalTrials.gov

What this trial studies

This study is a randomized, single-blind, comparative trial that evaluates the safety and pharmacokinetics of Complarate, a biosimilar to Actemra, in healthy volunteers. Participants aged 18-45 will receive a single subcutaneous dose of 162 mg of either Complarate or Actemra, followed by a 43-day follow-up period. The study aims to determine if Complarate is equivalent to Actemra in terms of safety and pharmacokinetics. A total of 256 healthy volunteers will be randomized into two groups for this assessment.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy men and women aged 18 to 45 years with a body weight between 50.0 to 90.0 kg and a BMI of 18.5 to 29.9.

Not a fit: Patients with hypersensitivity to any components of the study drug or those with a history of allergic reactions requiring treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence supporting the use of Complarate as a safe and effective alternative to Actemra for patients requiring treatment with tocilizumab.

How similar studies have performed: Other studies have shown success with similar biosimilar approaches, indicating a promising avenue for further exploration.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Moscow and 2 other locations

• State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department" — Moscow, Russian Federation (Recruiting)
• Federal State Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov Ministry of Health of Russia — Moscow, Russian Federation (Recruiting)
• LLC "X Seven Clinical Research" — Saint Petersburg, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Evgeny V. Zuev, MD

Conditions Healthy Volunteers; tocilizumab; humanized monoclonal antibodies; safety; pharmacokinetics; equivalence; biosimilar; IL-6 receptor