Healthy VolunteersPhase 1NCT06481189
A Safety, Pharmacokinetics and Pharmacodynamics Study of GNR-086 and Ilaris® in Healthy Volunteers
A Phase 1 study testing GNR-086 and Ilaris® in people with Healthy Volunteers, run by AO GENERIUM at 2 sites in Russia.
Trial summary
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris® in healthy volunteers. Participants received a single subcutaneous dose of canakinumab 150 mg. The follow up period was 120 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?
- GNR-086 and Ilaris®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesRussia
- Study dates
- 6 Sep 2022to 26 May 2023
- 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, obtained from the volunteer before the start of any procedures related to the study;
- Men and women aged 18 to 45 years, inclusive, at the time of signing the informed consent form;
- Verified diagnosis "healthy" (the diagnosis "healthy" is established on the basis of a detailed medical history, in the absence of deviations from normal values during a clinical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory data studies, results of electrocardiography and fluorography);
- Body weight from 50 to 85 kg, body mass index from 18.5 to 28 kg/m2, inclusive.
- Agreement to adhere to adequate methods of contraception during the entire period of participation in the study or for 3 months after administration of the study or reference drug in case of early termination of participation in the study.
Who cannot join
- Severe chronic diseases, history of seizures;
- Acute infectious diseases less than 4 weeks before administration of the study or reference drug;
- Any history of chronic or recurrent infectious diseases;
- History of tuberculosis;
- Vaccination with any vaccine within 3 months before the administration of the study or reference drug or planned for the period of the volunteer's participation in the study;
- Compounded allergy history; history of hypersensitivity to the active substance or other components of the study or reference drug;
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- Pregnancy or breastfeeding period;
- Special lifestyle (work at night, extreme physical activity);
- Deviations of vital signs: systolic pressure less than 100 mm Hg. Art. or more than 130 mm Hg. Art.; diastolic pressure less than 60 mm Hg. Art. or more than 90 mm Hg. Art.; heart rate less than 60 beats/min or more than 90 beats/min;
- Dehydration due to diarrhea, vomiting, or other cause within 24 hours prior to administration of the study or reference drug;
- Taking prescription medications within 28 days or 5 half-lives (whichever is longer) or taking over-the-counter medications/dietary supplements within 14 days prior to study or reference drug administration (occasional use of paracetamol at any time prior to study drug administration is acceptable) or reference drug);
- Blood donation or blood loss (450 ml of blood or more) less than 3 months before the administration of the study or reference drug and/or blood donation in any quantity planned for the period of the volunteer's participation in the study;
- Participation in clinical trials of medicinal products (less than 3 months or 5 half-lives from the study drug, whichever is longer) before administration of the investigational or reference drug of this study;
- Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of ethyl alcohol or 325 ml of beer), or information about a history of alcoholism, drug addiction, or drug abuse;
- Positive test for the presence of alcohol in exhaled air;
- Smoking more than 5 cigarettes per day for 3 months before this study;
- Positive urine test for the content of narcotic and potent drugs;
- Positive test for hepatitis B, C, HIV or syphilis;
- Any surgical interventions planned during the period of participation in the study;
- Unwillingness or inability to comply with the requirements of this protocol.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"
Moscow, 117556
Federal State Budgetary Educational Institution of Higher Education "Moscow State Medical and Dental University named after A.I. Evdokimov" of the Ministry of Health of the Russian Federation
Moscow, 127473
About this study
Official title: A Single-blind Randomized Parallel-group Comparative Study of the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of GNR-086 and Ilaris® After a Single Subcutaneous Administration to Healthy Volunteers at a Dose of 150 mg
This is a randomized single-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris® in healthy volunteers. Participants received a single subcutaneous dose of canakinumab 150 mg. The follow up period was 120 days.
Read the detailed description
GNR-086 (canakinumab) is being developed as a biosimilar to the drug Ilaris®, a lyophilisate for the preparation of solution for subcutaneous administration.
Canakinumab is a recombinant human monoclonal antibody against human interleukine-1β that belongs to the immunoglobulin G1/k (IgG1/k) isotype subclass.
This study is intended for a comparative study of the safety, pharmacokinetics and pharmacodynamics of the drug GNR-086 and the reference drug Ilaris® for the purpose of registration of the drug - GNR-086 (JSC GENERIUM, Russia), 150 mg, lyophilisate for the preparation of solution for subcutaneous administration in the Russian Federation. 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. 105 patients (53 to the study drug group and 52 to the comparator drug group) were randomized.
- Conditions
- Healthy Volunteers
- Being tested
- GNR-086, Ilaris®
- Keywords
- canakinumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, pharmacodynamics, interleukine-1β
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNR-086Biological
Also called canakinumab
The test drug GNR-086 was administered as a subcutaneous injection at a single dose of 150 mg.
Ilaris®Biological
Also called canakinumab
The reference drug Ilaris® was administered as a subcutaneous injection at a single dose of 150 mg.
| Study group | Role | What they receive |
|---|---|---|
| GNR-086 (JSC "GENERIUM", Russia) | Experimental | canakinumab biosimilar Receives: Biological: GNR-086 |
| Ilaris® (Novartis Pharma Stein AG, Switzerland) | Active comparator | canakinumab Receives: Biological: Ilaris® |
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) extrapolated to infinity (AUC(0-∞) of GNR-086 and Ilaris®
Measured: Day 120
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Analysis of equivalence of Cmax of GNR-086 and Ilaris®
Measured: Day 120
Secondary outcomes (4)
Pharmacodynamics: interleukin-1β (IL-1β)
IL-1β concentration
Measured: Day 120
Pharmacodynamics: Area Under IL-1β Curve (AUC)
Area under the curve "Relative difference in total IL-1β concentration compared to baseline - time"
Measured: Day 120
Proportion of volunteers with adverse events (AE)
The Investigator will carefully monitor each subject throughout the study for any AEs (coded to preferred term and system organ class using the Medical Dictionary for Regulatory Activities [MedDRA])
Measured: Day 120
Immunogenicity
Antidrug antibodies (ADA) level
Measured: Day 120
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 start6 Sep 2022
- Primary completion17 Mar 2023
- Study completion26 May 2023
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
- 105 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
- NCT06481189
- Sponsor's protocol ID
- CAN-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
- A Single-blind Randomized Parallel-group Comparative Study of the Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of GNR-086 and Ilaris® After a Single Subcutaneous Administration to Healthy Volunteers at a Dose of 150 mg
- ClinicalTrials.gov ID
- NCT06481189
- Acronym / sponsor ID
- CAN-HVL-I
- Conditions
- Healthy Volunteers
- Keywords
- canakinumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, pharmacodynamics, interleukine-1β
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 26 May 2023 (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 single-blind comparative parallel group study of the safety, pharmacokinetics and pharmacodynamics of GNR-086 and Ilaris® in healthy volunteers. Participants received a single subcutaneous dose of canakinumab 150 mg. The follow up period was 120 days.
Detailed description
GNR-086 (canakinumab) is being developed as a biosimilar to the drug Ilaris®, a lyophilisate for the preparation of solution for subcutaneous administration.
Canakinumab is a recombinant human monoclonal antibody against human interleukine-1β that belongs to the immunoglobulin G1/k (IgG1/k) isotype subclass.
This study is intended for a comparative study of the safety, pharmacokinetics and pharmacodynamics of the drug GNR-086 and the reference drug Ilaris® for the purpose of registration of the drug - GNR-086 (JSC GENERIUM, Russia), 150 mg, lyophilisate for the preparation of solution for subcutaneous administration in the Russian Federation. 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. 105 patients (53 to the study drug group and 52 to the comparator drug group) were randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNR-086 (JSC "GENERIUM", Russia) | Experimental | Biological: GNR-086canakinumab biosimilar |
| Ilaris® (Novartis Pharma Stein AG, Switzerland) | Active comparator | Biological: Ilaris®canakinumab |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent to participate in the study, obtained from the volunteer before the start of any procedures related to the study;
- Men and women aged 18 to 45 years, inclusive, at the time of signing the informed consent form;
- Verified diagnosis "healthy" (the diagnosis "healthy" is established on the basis of a detailed medical history, in the absence of deviations from normal values during a clinical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory data studies, results of electrocardiography and fluorography);
- Body weight from 50 to 85 kg, body mass index from 18.5 to 28 kg/m2, inclusive.
- Agreement to adhere to adequate methods of contraception during the entire period of participation in the study or for 3 months after administration of the study or reference drug in case of early termination of participation in the study.
Key exclusion criteria (20 listed)
- Severe chronic diseases, history of seizures;
- Acute infectious diseases less than 4 weeks before administration of the study or reference drug;
- Any history of chronic or recurrent infectious diseases;
- History of tuberculosis;
- Vaccination with any vaccine within 3 months before the administration of the study or reference drug or planned for the period of the volunteer's participation in the study;
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 |
|---|---|---|
| GNR-086Also: canakinumabThe test drug GNR-086 was administered as a subcutaneous injection at a single dose of 150 mg. | Biological | GNR-086 (JSC "GENERIUM", Russia) |
| Ilaris®Also: canakinumabThe reference drug Ilaris® was administered as a subcutaneous injection at a single dose of 150 mg. | Biological | Ilaris® (Novartis Pharma Stein AG, Switzerland) |
Primary outcome
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Time frame: Day 120
Analysis of equivalence of area under concentration-time curve from time 0 (predose) extrapolated to infinity (AUC(0-∞) of GNR-086 and Ilaris®
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Time frame: Day 120
Analysis of equivalence of Cmax of GNR-086 and Ilaris®
4 secondary outcomes
Pharmacodynamics: interleukin-1β (IL-1β)
Time frame: Day 120
Pharmacodynamics: Area Under IL-1β Curve (AUC)
Time frame: Day 120
Proportion of volunteers with adverse events (AE)
Time frame: Day 120
Immunogenicity
Time frame: Day 120
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 GNR-086 and Ilaris® 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 5 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 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 120). 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.