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Can a copy of a blockbuster arthritis drug match the original? scientists test it in healthy people

NCT ID NCT06488521

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a biosimilar version of tocilizumab, called Complarate, behaves like the original drug, Actemra, in healthy volunteers. The study gives a single under-the-skin injection of either Complarate or Actemra to 256 healthy adults aged 18 to 45. The team measures drug levels in the blood over 43 days and tracks side effects to see if the two versions are equivalent.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tocilizumab biosimilar (Complarate) and tocilizumab (Actemra)
What this could lead to
If the biosimilar matches Actemra in safety and blood levels, it could offer a lower-cost alternative for people who need tocilizumab.
What could go wrong
This is an early-stage study in healthy volunteers, so it cannot show whether the biosimilar works for any disease. Biosimilars can still differ in immune reactions or side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

256 people

The number who actually took part.

Started

Jun 2024

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 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

  • LLC "X Seven Clinical Research"

    Saint Petersburg, Sankt-Peterburg, 194156, Russia

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

    Moscow, Moscow, 117556, Russia

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