A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers

NCT06488521 | Active Not Recruiting Phase 1

• 1 other identifier: GNR087s-RA012
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 3

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 subcutaneous dose of tocilizumab 162 mg. The follow up period was 43 days.

Conditions

Healthy Volunteers

Keywords

tocilizumab; humanized monoclonal antibodies; safety; pharmacokinetics; equivalence; biosimilar; IL-6 receptor; solution; subcutaneous administration

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)

  Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity of Complarate and Actemra®

  Day 43

• Pharmacokinetics: Peak Plasma Concentration (Cmax)

  Analysis of equivalence of Cmax of Complarate and Actemra®

  Day 43

Secondary Outcomes (2)

• Proportion of volunteers with adverse events (AE)

  Day 43

• Proportion of volunteers with ADA

  Day 43

Study Arms (2)

Complarate (JSC "GENERIUM", Russia)

EXPERIMENTAL

tocilizumab biosimilar

Biological: Complarate

Actemra® (F. Hoffmann-La Roche Ltd., Switzerland)

ACTIVE COMPARATOR

tocilizumab

Biological: Actemra®

Interventions

Complarate BIOLOGICAL

Complarate solution, a subcutaneous injection at a single dose of 162 mg.

Also known as: Tocilizumab biosimilar

Complarate (JSC "GENERIUM", Russia)

Actemra® BIOLOGICAL

Actemra® solution, subcutaneous injection at a single dose of 162 mg.

Also known as: Tocilizumab

Actemra® (F. Hoffmann-La Roche Ltd., Switzerland)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (3)

State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"

Moscow, Moscow, 117556, Russia

Location

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, 119435, Russia

Location

LLC "X Seven Clinical Research"

Saint Petersburg, Sankt-Peterburg, 194156, Russia

Location

MeSH Terms

Interventions

tocilizumab

Study Officials

• Oksana A. Markova, MD

  JSC GENERIUM

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: June 20, 2024
• Primary Completion: April 30, 2025
• Study Completion: September 30, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)