Healthy VolunteersPhase 1NCT06481215
A Safety and Pharmacokinetics Study of Ustekinumab Biosimilar GNR-068 and Stelara® in Healthy Volunteers
A Phase 1 study testing GNR-068 and Stelara® in people with Healthy Volunteers, run by AO GENERIUM at 2 sites in Russia.
Trial summary
This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg. The follow up period was 84 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?
- GNR-068 and Stelara®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesRussia
- Study dates
- 11 Mar 2022to 20 Dec 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.
- Diagnosis of "healthy" based on clinical and biochemical blood tests, urine tests, physical examination results, measurements of vital signs, electrocardiography and fluorography results.
- 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 adhere to adequate methods of contraception during the entire period of participation in the study.
- Volunteers should not have donated blood and its components 30 days before inclusion in the study and not become donors of blood and its products during the entire study and within 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 30 days 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 10 cigarettes a day.
- Drug dependence and a positive urine test for the content of narcotic and potent drugs.
- Positive test results 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.
- Reluctance to comply with contraceptive methods.
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: An Randomized Comparative Parallel-group Trial of the Safety, Pharmacokinetics, and Immunogenicity of the Drug GNR-068 and the Drug Stelara® After Their Single Subcutaneous Administration to Healthy Volunteers at a Dose of 45 mg
This is a randomized open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg. The follow up period was 84 days.
Read the detailed description
GNR-068 (ustekinumab) is being developed as a biosimilar to the drug Stelara®, a solution for subcutaneous administration (manufacturer Silag AG, Switzerland, holder of authority Johnson \& Johnson).
Ustekinumab is a recombinant human monoclonal antibody against the p40 subunit. The p40 subunit is common to interleukine-23 (IL-23) and IL-12. IL-23 is a dimer consisting of p40 and p19. IL-12 is a dimer consisting of p40 and p35. With its target site p40, ustekinumab blocks two different mechanisms of T cell activation, namely Th1 and Th17 selection.
This study is intended for a comparative study of the safety and pharmacokinetics of the drug GNR-068 and the drug Stelara® for the purpose of registration of the drug - GNR-068, 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. 122 patients (60 to the study drug group and 62 to the comparator drug group) were randomized.
- Conditions
- Healthy Volunteers
- Being tested
- GNR-068, Stelara®
- Keywords
- ustekinumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, p40 subunit, IL-23, IL-12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNR-068Biological
Also called ustekinumab biosimilar
The investigational product GNR-068 was administered as a subcutaneous injection at a single dose of 45 mg.
Stelara®Biological
Also called ustekinumab
The reference product Stelara® was administered as a subcutaneous injection at a single dose of 45 mg.
| Study group | Role | What they receive |
|---|---|---|
| GNR-068 (JSC GENERIUM, Russia) | Experimental | ustekinumab biosimilar Receives: Biological: GNR-068 |
| Stelara® (manufacturer Silag AG, Switzerland, holder of authorisation Johnson & Johnson) | Active comparator | ustekinumab Receives: Biological: Stelara® |
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 AUC from time 0 (predose) to the last quantifiable data point and extrapolated to infinity of GNR-068 and Stelara®
Measured: Day 84
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Analysis of equivalence of maximum concentration (Cmax) of GNR-068 and Stelara®
Measured: Day 84
Secondary outcomes (2)
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 84
Proportion of patients with Antidrug antibodies (ADA)
Binding and neutralizing ADA will be identified
Measured: Day 84
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 Mar 2022
- Primary completion4 Sep 2022
- Study completion20 Dec 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
- None (open label)
- Enrolment
- 122 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
- NCT06481215
- Sponsor's protocol ID
- UKM-PS-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
- An Randomized Comparative Parallel-group Trial of the Safety, Pharmacokinetics, and Immunogenicity of the Drug GNR-068 and the Drug Stelara® After Their Single Subcutaneous Administration to Healthy Volunteers at a Dose of 45 mg
- ClinicalTrials.gov ID
- NCT06481215
- Acronym / sponsor ID
- UKM-PS-I
- Conditions
- Healthy Volunteers
- Keywords
- ustekinumab, humanized monoclonal antibodies, safety, pharmacokinetics, equivalence, biosimilar, p40 subunit, IL-23
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 4 Sep 2022 (actual)
- Study completion
- 20 Dec 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 open comparative parallel group study of the safety and pharmacokinetics of GNR-068 and Stelara® in healthy volunteers. Participants received a single subcutaneous dose of ustekinumab 45 mg. The follow up period was 84 days.
Detailed description
GNR-068 (ustekinumab) is being developed as a biosimilar to the drug Stelara®, a solution for subcutaneous administration (manufacturer Silag AG, Switzerland, holder of authority Johnson \& Johnson).
Ustekinumab is a recombinant human monoclonal antibody against the p40 subunit. The p40 subunit is common to interleukine-23 (IL-23) and IL-12. IL-23 is a dimer consisting of p40 and p19. IL-12 is a dimer consisting of p40 and p35. With its target site p40, ustekinumab blocks two different mechanisms of T cell activation, namely Th1 and Th17 selection.
This study is intended for a comparative study of the safety and pharmacokinetics of the drug GNR-068 and the drug Stelara® for the purpose of registration of the drug - GNR-068, 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. 122 patients (60 to the study drug group and 62 to the comparator drug group) were randomized.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNR-068 (JSC GENERIUM, Russia) | Experimental | Biological: GNR-068ustekinumab biosimilar |
| Stelara® (manufacturer Silag AG, Switzerland, holder of authorisation Johnson & Johnson) | Active comparator | Biological: Stelara®ustekinumab |
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.
- Diagnosis of "healthy" based on clinical and biochemical blood tests, urine tests, physical examination results, measurements of vital signs, electrocardiography and fluorography results.
- 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.
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 |
|---|---|---|
| GNR-068Also: ustekinumab biosimilarThe investigational product GNR-068 was administered as a subcutaneous injection at a single dose of 45 mg. | Biological | GNR-068 (JSC GENERIUM, Russia) |
| Stelara®Also: ustekinumabThe reference product Stelara® was administered as a subcutaneous injection at a single dose of 45 mg. | Biological | Stelara® (manufacturer Silag AG, Switzerland, holder of authorisation Johnson & Johnson) |
Primary outcome
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Time frame: Day 84
Analysis of equivalence of AUC from time 0 (predose) to the last quantifiable data point and extrapolated to infinity of GNR-068 and Stelara®
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Time frame: Day 84
Analysis of equivalence of maximum concentration (Cmax) of GNR-068 and Stelara®
2 secondary outcomes
Proportion of volunteers with adverse events (AE)
Time frame: Day 84
Proportion of patients with Antidrug antibodies (ADA)
Time frame: Day 84
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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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-068 and Stelara® 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 84). 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.