Healthy VolunteersPhase 1NCT06481202
A Safety and Pharmacokinetic Study of Complarate (Tocilizumab Biosimilar) and Actemra® in Healthy Volunteers
A Phase 1 study testing Complarate® and Actemra® in people with Healthy Volunteers, run by AO GENERIUM at 2 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy 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
- 43 participants
- Where
- 2 sitesRussia
- Study dates
- 11 Apr 2022to 19 Aug 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Volunteers should not be donors of blood and its components 3 months before inclusion in the study and not become donors of blood and its products during the entire study and for 30 days after its completion.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
- Unwillingness or inability to comply with the recommendations prescribed by this protocol.
- Any planned surgical intervention during the study period.
- Identification during screening of other diseases/conditions not listed above that, in the opinion of the doctor-researcher, prevent the inclusion of a volunteer in the study.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Department of Clinical Research, Center for Clinical Drug Research
Moscow, 119435
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
About this study
Official title: Double-blind Randomized Study of the Safety, Pharmacokinetics and Pharmacodynamics of the Drugs Complarate (JSC GENERIUM, Russia) and Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) in Parallel Groups of Healthy Volunteers
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
Read the detailed description
Complarate (tocilizumab) is being developed as a biosimilar to the drug Actemra®, a concentrate for the preparation of a solution for infusion.
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass of immunoglobulins. 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 intravenous administration to healthy volunteers at a dose of 8 mg/kg. 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. 46 healthy volunteers (23 to the study drug group and 23 to the reference drug group) were randomized.
- Conditions
- Healthy Volunteers
- Being tested
- Complarate®, Actemra®
- Keywords
- tocilizumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, IL-6 receptor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complarate®Biological
Also called tocilizumab biosimilar, GNR-087
The test drug Complarate® was administered as an intravenous infusion at a single dose of 8 mg/kg.
Actemra®Biological
Also called tocilizumab
The reference drug Actemra® was administered as an intravenous infusion at a single dose of 8 mg/kg.
| 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 (5)
Pharmacodynamics: Concentration of interleukine-6 (IL-6)
IL-6 concentration
Measured: day 43
Pharmacodynamics: Concentration of soluble interleukine-6 receptor (sIL-6R)
sIL-6R concentration
Measured: day 43
Pharmacodynamics: Concentration of high-sensitivity C-reactive protein (hsCRP)
hsCRP concentration
Measured: day 43
Adverse events
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
Immunogenicity
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 posted1 Jul 2024
- Study start11 Apr 2022
- Primary completion14 Jun 2022
- Study completion19 Aug 2022
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 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
- NCT06481202
- Sponsor's protocol ID
- TZS-HVL-I
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 1 Jul 2024
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Study of the Safety, Pharmacokinetics and Pharmacodynamics of the Drugs Complarate (JSC GENERIUM, Russia) and Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) in Parallel Groups of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06481202
- Acronym / sponsor ID
- TZS-HVL-I
- Conditions
- Healthy Volunteers
- Keywords
- tocilizumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, IL-6 receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 1 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 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
Detailed description
Complarate (tocilizumab) is being developed as a biosimilar to the drug Actemra®, a concentrate for the preparation of a solution for infusion.
Tocilizumab is a recombinant humanized monoclonal antibody to the human interleukin-6 (IL-6) receptor from the immunoglobulin G1 (IgG1) subclass of immunoglobulins. 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 intravenous administration to healthy volunteers at a dose of 8 mg/kg. 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. 46 healthy volunteers (23 to the study drug group and 23 to the reference drug group) were randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complarate® (JSC "GENERIUM", Russia) | Experimental | Biological: Complarate®tocilizumab biosimilar |
| Actemra® (F. Hoffmann-La Roche Ltd., Switzerland) | Active comparator | Biological: Actemra®tocilizumab |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
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 |
|---|---|---|
| Complarate®Also: tocilizumab biosimilar, GNR-087The test drug Complarate® was administered as an intravenous infusion at a single dose of 8 mg/kg. | Biological | Complarate® (JSC "GENERIUM", Russia) |
| Actemra®Also: tocilizumabThe reference drug Actemra® was administered as an intravenous infusion at a single dose of 8 mg/kg. | 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®
5 secondary outcomes
Pharmacodynamics: Concentration of interleukine-6 (IL-6)
Time frame: day 43
Pharmacodynamics: Concentration of soluble interleukine-6 receptor (sIL-6R)
Time frame: day 43
Pharmacodynamics: Concentration of high-sensitivity C-reactive protein (hsCRP)
Time frame: day 43
Adverse events
Time frame: day 43
Immunogenicity
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 1 Jul 2024.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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
2 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 2 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 7 inclusion and 18 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 Jul 2024.