Allergic AsthmaPhase 1NCT06494345
A Study of Genolair in Two Dosage Forms (Solution and Lyophilisate) and Xolair® in Healthy Volunteers
A Phase 1 study testing Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration and Xolair®, solution for subcutaneous administration, 150 mg in people with Allergic Asthma, run by AO GENERIUM at 1 site in Russia.
Trial summary
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration and Xolair®, solution for subcutaneous administration, 150 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2023to 9 Jun 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Availability of written informed consent obtained from the volunteer prior to the start of any procedures related to the study;
- Men and women between the ages of 18 and 55 (inclusive) at the time of the Informed Consent Form including those diagnosed with atopic bronchial asthma (BA) and/or allergic rhinitis (AR) of mild severity according to the Investigator's conclusion;
- The absence of clinically significant changes in the volunteers according to the results of a physical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory tests, electrocardiography, and fluorography/chest X-ray;
- Bodyweight from 50 to 90 kg inclusive;
- Body mass index 18.5-30 kg / m2 inclusive;
- Initial concentration of total IgE: ≥30 IU / ml and ≤300 IU / m;
- The volume of forced exhalation in the first second (OFV1) ≥ 80% of the required value;
- Comply with the rules of contraception by the study participants.
Who cannot join
- History of use of drugs based on anti-IgE monoclonal antibodies.*
- Use of drugs based on monoclonal antibodies (in routine practice for therapy and/or as part of a clinical trial) for ≤1 year before signing the informed consent AND/OR single use of drugs based on monoclonal antibodies (in routine practice for therapy and /or as part of a clinical trial) for ≤6 (six) half-lives of the drug before signing the informed consent.
- Use of drugs that affect the pharmacokinetics or pharmacodynamics of the study drugs (use of systemic corticosteroids for ≤30 days before signing the informed consent; use of systemic corticosteroids and monoclonal antibody preparations other than those being studied during the study period; use of immunosuppressive drugs, except for systemic corticosteroids, during the study period and/or use of these drugs for ≤30 days before signing the informed consent; vaccination (with any vaccine) within ≤30 days before signing the informed consent and/or the need for vaccination during the study period; initiation of allergen-specific immunotherapy within ≤3 months before signing the informed consent and/or need for its implementation during the study period).
- A history of an adverse drug reaction to any of the components of the study drug or comparator drugs.
- History of an autoimmune disease.
- A history of a disease associated with the accumulation of immune complexes (including serum sickness).
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- The presence of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, which, in the opinion of the Researcher, put the safety of the volunteer at risk when participating in the study, or which will impact on the analysis of safety data if an exacerbation of this disease occurs during the study period.
- Acute infectious diseases less than 4 weeks before signing the informed consent.
- A history of any cancer.
- History of mental illness.
- Donation of blood and its components or blood loss (450 ml of blood or more) less than 3 months before signing the informed consent.
- Participation in clinical trials of drugs less than 3 months before signing the informed consent.
- 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.
- Regular alcohol consumption exceeding 5 units. alcohol per week (where each unit is equal to 30 ml of strong alcohol, 100 ml of wine or 250 ml of beer) or anamnestic information about alcoholism, drug addiction, drug abuse.
- Positive test for the presence of alcohol in exhaled air.
- Smoking more than 5 cigarettes per day for 3 months before signing the informed consent.
- Drug dependence and a positive urine test for the use of prohibited drugs and substances.
- Positive test results for hepatitis B and/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
1 site in 1 country.
Russia1 site
State budgetary healthcare institution of the city of Moscow "City Clinic No. 2 of the Moscow Health Department"
Moscow, 117556
About this study
Official title: An Open-label Randomized Comparative Study in Parallel Groups of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Genolair as Solution and Lyophilisate Forms and Xolair® in a Solution Form
This is a phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in healthy volunteers
Read the detailed description
The drug Genolair (JSC "GENERIUM", Russia) is a humanized recombinant monoclonal antibody selectively binding to immunoglobulin E (IgE) and it can reduce the amount of free IgE, which is the trigger factor for a cascade of allergic reactions.
Considering the leading pathogenesis role of IgE-mediated allergy, the use of drugs to block IgE makes it possible to control the disease at the earliest allergic reaction phase of the development. It was shown that the IgE elimination from the mast cells and basophils surface reduced the severity of acute allergic reactions, reduced the allergen-induced late phase of the immune response and infiltration with inflammatory cells.
The drug Genolair is a biosimilar to the original drug Xolair® and it is registered in Russian Federation for therapy bronchial asthma and chronic idiopathic urticaria in the form of lyophilisate for the preparation of solution for subcutaneous administration.
This study is aimed to compare the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the drug Genolair solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration and the drug Xolair® solution for subcutaneous administration to register of the drug Genolair (solution for subcutaneous administration) in the Russian Federation.
In this open-label randomized parallel-group study adult volunteers (n = 180) aged 18 to 55 years with serum IgE level 30-300 IU/ml and body weight 50-90 kg receive a single subcutaneous dose (150 mg) of solution of the drug Genolair or lyophilisate for the preparation of solution of the drug Genolair or solution of the drug Xolair®. Serum concentrations of total omalizumab, free IgE and safety and immunogenicity will be determined up to 85 days post dose.
- Conditions
- Allergic Asthma
- Being tested
- Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration, Xolair®, solution for subcutaneous administration, 150 mg
- Keywords
- Omalizumab, Allergic rhinitis, Monoclonal antibody, IgE, Bioequivalence, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Respiratory Hypersensitivity, Immune System Diseases, Anti-Allergic Agents
- Medical subject headings
- Rhinitis, Allergic, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Respiratory Hypersensitivity, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genolair, solution for subcutaneous administration, 150 mgBiological
Also called Omalizumab biosimilar solution
Genolair (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration
Genolair, lyophilisate for the preparation of solution for subcutaneous administrationBiological
Also called Omalizumab biosimilar lyophilisate
Genolair (omalizumab), lyophilisate for the preparation of solution for subcutaneous administration, 150 mg for single subcutaneous administration
Xolair®, solution for subcutaneous administration, 150 mgBiological
Also called Omalizumab solution
Xolair® (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| Genolair, solution for subcutaneous administration | Experimental | Omalizumab biosimilar Receives: Biological: Genolair, solution for subcutaneous administration, 150 mg |
| Genolair, lyophilisate for the preparation of solution for subcutaneous administration | Active comparator | Omalizumab biosimilar Receives: Biological: Genolair, lyophilisate for the preparation of solution for subcutaneous administration |
| Xolair®, solution for subcutaneous administration | Active comparator | Omalizumab Receives: Biological: Xolair®, solution for subcutaneous administration, 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Analysis of equivalence of Cmax
Measured: Day 85
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
Measured: Day 85
Secondary outcomes (2)
Proportion of participants 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 85
Area under the curve "Relative difference in the free IgE concentration compared to the initial value - time"
Time-points: 5-15 minutes before drug administration, in 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 984, 1344, 1680, 2016 hours after drug administration
Measured: 2016 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start15 Jan 2023
- Primary completion9 Jun 2024
- Study completion9 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies 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
- 180 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
- NCT06494345
- Sponsor's protocol ID
- OMA-COMP-I
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 10 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Randomized Comparative Study in Parallel Groups of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Genolair as Solution and Lyophilisate Forms and Xolair® in a Solution Form
- ClinicalTrials.gov ID
- NCT06494345
- Acronym / sponsor ID
- OMA-COMP-I
- Conditions
- Allergic Asthma
- Keywords
- Omalizumab, Allergic rhinitis, Monoclonal antibody, IgE, Bioequivalence, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 9 Jun 2024 (actual)
- Study completion
- 9 Jun 2024 (actual)
- First posted
- 10 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 phase I an open-label randomized comparative study in parallel groups of pharmacokinetics, pharmacodynamics, immunogenicity, and safety of Genolair in two dosage forms (solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration) and Xolair® in healthy volunteers
Detailed description
The drug Genolair (JSC "GENERIUM", Russia) is a humanized recombinant monoclonal antibody selectively binding to immunoglobulin E (IgE) and it can reduce the amount of free IgE, which is the trigger factor for a cascade of allergic reactions.
Considering the leading pathogenesis role of IgE-mediated allergy, the use of drugs to block IgE makes it possible to control the disease at the earliest allergic reaction phase of the development. It was shown that the IgE elimination from the mast cells and basophils surface reduced the severity of acute allergic reactions, reduced the allergen-induced late phase of the immune response and infiltration with inflammatory cells.
The drug Genolair is a biosimilar to the original drug Xolair® and it is registered in Russian Federation for therapy bronchial asthma and chronic idiopathic urticaria in the form of lyophilisate for the preparation of solution for subcutaneous administration.
This study is aimed to compare the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the drug Genolair solution for subcutaneous administration and lyophilisate for the preparation of solution for subcutaneous administration and the drug Xolair® solution for subcutaneous administration to register of the drug Genolair (solution for subcutaneous administration) in the Russian Federation.
In this open-label randomized parallel-group study adult volunteers (n = 180) aged 18 to 55 years with serum IgE level 30-300 IU/ml and body weight 50-90 kg receive a single subcutaneous dose (150 mg) of solution of the drug Genolair or lyophilisate for the preparation of solution of the drug Genolair or solution of the drug Xolair®. Serum concentrations of total omalizumab, free IgE and safety and immunogenicity will be determined up to 85 days post dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genolair, solution for subcutaneous administration | Experimental | Biological: Genolair, solution for subcutaneous administration, 150 mgOmalizumab biosimilar |
| Genolair, lyophilisate for the preparation of solution for subcutaneous administration | Active comparator | Biological: Genolair, lyophilisate for the preparation of solution for subcutaneous administrationOmalizumab biosimilar |
| Xolair®, solution for subcutaneous administration | Active comparator | Biological: Xolair®, solution for subcutaneous administration, 150 mgOmalizumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Availability of written informed consent obtained from the volunteer prior to the start of any procedures related to the study;
- Men and women between the ages of 18 and 55 (inclusive) at the time of the Informed Consent Form including those diagnosed with atopic bronchial asthma (BA) and/or allergic rhinitis (AR) of mild severity according to the Investigator's conclusion;
- The absence of clinically significant changes in the volunteers according to the results of a physical examination, including measurement of blood pressure, heart rate, respiratory rate, body temperature, as well as laboratory tests, electrocardiography, and fluorography/chest X-ray;
- Bodyweight from 50 to 90 kg inclusive;
- Body mass index 18.5-30 kg / m2 inclusive;
Key exclusion criteria (22 listed)
- History of use of drugs based on anti-IgE monoclonal antibodies.*
- Use of drugs based on monoclonal antibodies (in routine practice for therapy and/or as part of a clinical trial) for ≤1 year before signing the informed consent AND/OR single use of drugs based on monoclonal antibodies (in routine practice for therapy and /or as part of a clinical trial) for ≤6 (six) half-lives of the drug before signing the informed consent.
- Use of drugs that affect the pharmacokinetics or pharmacodynamics of the study drugs (use of systemic corticosteroids for ≤30 days before signing the informed consent; use of systemic corticosteroids and monoclonal antibody preparations other than those being studied during the study period; use of immunosuppressive drugs, except for systemic corticosteroids, during the study period and/or use of these drugs for ≤30 days before signing the informed consent; vaccination (with any vaccine) within ≤30 days before signing the informed consent and/or the need for vaccination during the study period; initiation of allergen-specific immunotherapy within ≤3 months before signing the informed consent and/or need for its implementation during the study period).
- A history of an adverse drug reaction to any of the components of the study drug or comparator drugs.
- History of an autoimmune disease.
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 |
|---|---|---|
| Genolair, solution for subcutaneous administration, 150 mgAlso: Omalizumab biosimilar solutionGenolair (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration | Biological | Genolair, solution for subcutaneous administration |
| Genolair, lyophilisate for the preparation of solution for subcutaneous administrationAlso: Omalizumab biosimilar lyophilisateGenolair (omalizumab), lyophilisate for the preparation of solution for subcutaneous administration, 150 mg for single subcutaneous administration | Biological | Genolair, lyophilisate for the preparation of solution for subcutaneous administration |
| Xolair®, solution for subcutaneous administration, 150 mgAlso: Omalizumab solutionXolair® (omalizumab), solution for subcutaneous administration, 150 mg for single subcutaneous administration | Biological | Xolair®, solution for subcutaneous administration |
Primary outcome
Pharmacokinetics: Peak Plasma Concentration (Cmax)
Time frame: Day 85
Analysis of equivalence of Cmax
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
Time frame: Day 85
Analysis of equivalence of area under concentration-time curve from time 0 (predose) to the last quantifiable data point and to infinity
2 secondary outcomes
Proportion of participants with Adverse Events (AE)
Time frame: Day 85
Area under the curve "Relative difference in the free IgE concentration compared to the initial value - time"
Time frame: 2016 hours
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 10 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genolair, solution for subcutaneous administration, 150 mg, Genolair, lyophilisate for the preparation of solution for subcutaneous administration and Xolair®, solution for subcutaneous administration, 150 mg in people with Allergic Asthma, run by AO GENERIUM at 1 site 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 8 inclusion and 22 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 10 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 1 site 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: Peak Plasma Concentration (Cmax) (time frame: Day 85). 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 10 Jul 2024.