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

NCT06481202 | Completed Phase 1

• 1 other identifier: TZS-HVL-I
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized double-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of Complarate and Actemra® in healthy volunteers. Participants received a single intravenous dose of tocilizumab 8 mg/kg. The follow up period was 43 days

Conditions

Healthy Volunteers

Keywords

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

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 (5)

• Pharmacodynamics: Concentration of interleukine-6 (IL-6)

  day 43

• Pharmacodynamics: Concentration of soluble interleukine-6 receptor (sIL-6R)

  day 43

• Pharmacodynamics: Concentration of high-sensitivity C-reactive protein (hsCRP)

  day 43

• Adverse events

  day 43

• Immunogenicity

  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

The test drug Complarate® was administered as an intravenous infusion at a single dose of 8 mg/kg.

Also known as: tocilizumab biosimilar, GNR-087

Complarate® (JSC "GENERIUM", Russia)

Actemra® BIOLOGICAL

The reference drug Actemra® was administered as an intravenous infusion at a single dose of 8 mg/kg.

Also known as: tocilizumab

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

Eligibility Criteria

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

You may qualify if:

• Men aged 18 to 45 years (inclusive) at the time of signing the Informed Consent Form.
• The diagnosis is "healthy", concluded by a doctor-researcher based on the analysis of clinical and biochemical blood tests, urine tests, the results of a physical examination, measurements of vital signs, the results of electrocardiography and fluorography. In this case, the volunteer should not have any deviations in the tests carried out as part of the protocol.
• Conclusion of a dentist on the sanitation of the oral cavity.
• Availability of written informed consent obtained from the volunteer before the start of any procedures related to the study.
• Body weight from 60 to 90 kg inclusive.
• Body mass index 18.5-30 kg/m2 inclusive. Agreement to follow adequate methods of contraception for 3 months after administration of the study drug.

You may not qualify if:

• Use of drugs based on monoclonal antibodies for 1 year before drug administration.
• Vaccination (with any vaccine) within 30 days before signing the informed consent and/or the need for vaccination during the study period.
• A history of an adverse drug reaction to any of the components of the study drug or a reference drug.
• History of an autoimmune disease.
• A history of a disease associated with the accumulation of immune complexes (including serum sickness).
• History of cancer.
• The presence of chronic diseases of the cardiovascular, bronchopulmonary (including bronchospastic diseases), neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, and mental illnesses.
• Acute infectious diseases less than 4 weeks before signing the informed consent.
• Blood donation or blood loss (450 ml of blood or more) less than 3 months before the start of the study.
• Participation in clinical trials of drugs less than 3 months before signing the informed consent.
• Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol) or anamnestic information about alcoholism, drug addiction, or drug abuse in the anamnesis.
• Positive test for the presence of alcohol in exhaled air.
• Smoking more than 5 cigarettes per day for 3 months before the study.
• Drug dependence and a positive urine test for the content of narcotic and potent drugs.
• Positive test for hepatitis B or C, HIV or syphilis.

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (2)

Department of Clinical Research, Center for Clinical Drug Research

Moscow, 119435, Russia

Location

Federal State Autonomous Educational Institution of Higher Education "First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of Russia

Moscow, 119991, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the investigators nor the patients knew which drug was being administered
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 1, 2024
• Study Start: April 11, 2022
• Primary Completion: June 14, 2022
• Study Completion: August 19, 2022
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2)