Healthy VolunteersPhase 1NCT06488521
A Safety and Pharmacokinetics Study of Complarate (Tocilizumab Biosimilar Solution) and Actemra® in Healthy Volunteers
A Phase 1 study testing Complarate and Actemra® in people with Healthy Volunteers, run by AO GENERIUM at 3 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Complarate and Actemra®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 3 sitesRussia
- Study dates
- 20 Jun 2024to 28 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 20Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"
Moscow, Moscow, 117556
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
LLC "X Seven Clinical Research"
Saint Petersburg, Sankt-Peterburg, 194156
About this study
Official title: 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 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.
Read the 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 human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass. Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors (sIL-6R and mIL-6R).
This I phase study is aimed to compare the pharmacokinetics and safety of the drugs Complarate and Actemra® after their single subcutaneous administration to healthy volunteers at a dose of 162 mg. The study included healthy volunteers aged 18-45 years at the time of signing the informed consent form. The study included a screening period, single administration of study/comparator drug and a follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1 to the study drug and comparator drug. 256 patients (128 to the study drug group and 128 to the comparator drug group) are being randomized.
- Conditions
- Healthy Volunteers
- Being tested
- Complarate, Actemra®
- Keywords
- tocilizumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, IL-6 receptor, solution, subcutaneous administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComplarateBiological
Also called Tocilizumab biosimilar
Complarate solution, a subcutaneous injection at a single dose of 162 mg.
Actemra®Biological
Also called Tocilizumab
Actemra® solution, subcutaneous injection at a single dose of 162 mg.
| Study group | Role | What they receive |
|---|---|---|
| Complarate (JSC "GENERIUM", Russia) | Experimental | tocilizumab biosimilar Receives: Biological: Complarate |
| Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) | Active comparator | tocilizumab Receives: Biological: Actemra® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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®
Measured: Day 43
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Analysis of equivalence of Cmax of Complarate and Actemra®
Measured: Day 43
Secondary outcomes (2)
Proportion of volunteers with adverse events (AE)
The Investigator will carefully monitor each subject throughout the study for any adverse events (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities [MedDRA])
Measured: Day 43
Proportion of volunteers with ADA
Antidrug antibodies (ADA) level
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start20 Jun 2024
- Primary completion30 Apr 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oksana A. Markova, MD, Study chair, JSC GENERIUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488521
- Sponsor's protocol ID
- GNR087s-RA012
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06488521
- Acronym / sponsor ID
- GNR087s-RA012
- Conditions
- Healthy Volunteers
- Keywords
- tocilizumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, IL-6 receptor, solution
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass. Tocilizumab binds to and inhibits both soluble and membrane IL-6 receptors (sIL-6R and mIL-6R).
This I phase study is aimed to compare the pharmacokinetics and safety of the drugs Complarate and Actemra® after their single subcutaneous administration to healthy volunteers at a dose of 162 mg. The study included healthy volunteers aged 18-45 years at the time of signing the informed consent form. The study included a screening period, single administration of study/comparator drug and a follow up period. Allocation of patients to treatment groups was carried out by randomization in a ratio of 1:1 to the study drug and comparator drug. 256 patients (128 to the study drug group and 128 to the comparator drug group) are being randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complarate (JSC "GENERIUM", Russia) | Experimental | Biological: Complaratetocilizumab biosimilar |
| Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) | Active comparator | Biological: Actemra®tocilizumab |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComplarateAlso: Tocilizumab biosimilarComplarate solution, a subcutaneous injection at a single dose of 162 mg. | Biological | Complarate (JSC "GENERIUM", Russia) |
| Actemra®Also: TocilizumabActemra® solution, subcutaneous injection at a single dose of 162 mg. | Biological | Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) |
Primary outcome
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Time frame: Day 43
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®
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Time frame: Day 43
Analysis of equivalence of Cmax of Complarate and Actemra®
2 secondary outcomes
Proportion of volunteers with adverse events (AE)
Time frame: Day 43
Proportion of volunteers with ADA
Time frame: Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oksana A. Markova, MD study chair
JSC GENERIUM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Complarate and Actemra® in people with Healthy Volunteers, run by AO GENERIUM at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) (time frame: Day 43). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.