Healthy VolunteersPhase 1NAPNCT04601389
Study of Pharmacokinetics, Pharmacodynamics and Safety Assessment of GNR-044 (JSC GENERIUM, Russia) and Xolair®
A Phase 1 study testing Omalizumab (JSC "GENERIUM", the Russian Federation) and Xolair® (Novartis Pharma AG, Switzerland) in people with Healthy Volunteers, run by AO GENERIUM at 2 sites in Russia.
Trial summary
An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland) after single subcutaneous administration in healthy volunteers at 150 mg Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Omalizumab (JSC "GENERIUM", the Russian Federation) and Xolair® (Novartis Pharma AG, Switzerland)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesRussia
- Study dates
- 18 Apr 2017to 6 Sep 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between the ages of 18 and 50 (inclusive) at the time of the Informed Consent Form.
- The diagnosis is "healthy" according to haematology and biochemical blood tests, urinalysis, results of physical examination, measurements of vital signs, results of electrocardiography.
- Bodyweight from 40 to 90 kg inclusive.
- Body mass index 18.5-30 kg / m2 inclusive.
- Initial concentration of total IgE: ≥30 IU / ml and ≤300 IU / ml.
- Comply with the rules of contraception by the study participants.
Who cannot join
- Monoclonal antibodies administration within 1 year before taking omalizumab.
- Hypersensitivity to any of the used study drug, to their components, history of an undesirable drug reaction.
- Concurrent diseases and conditions with potential impact on the patient's safety, pharmacokinetics or pharmacodynamics.
- The drug's use that affects pharmacokinetics or pharmacodynamics (injectable glucocorticosteroid drugs, allergen-specific immunotherapy, immunosuppressive drugs, vaccination within 30 days before signing informed consent and/or the need for vaccination during the study period).
- Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
- Patients with severe medical conditions that in the view of the investigator prohibits participation in the study.
- Concurrent therapy with investigational agents.
- A history of autoimmune disease.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
State budgetary institution of health care of the city of Moscow "City outpatients clinic No. 2 of the Department of Health of the city of Moscow"
Moscow, RF, 117556
Federal State Budgetary Institution "State Scientific Center Institute of Immunology" by Federal Medical and Biological Agency of the Russian Federation
Moscow, 115478
About this study
Official title: An Open-label, Randomized, in Parallel Groups Comparative Study of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Omalizumab (JSC "GENERIUM", Russia) and Xolair® ("Novartis Pharma AG", Switzerland) After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg
An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland) after single subcutaneous administration in healthy volunteers at 150 mg
Read the detailed description
There is an increasing incidence of bronchial asthma (BA) and other allergic diseases around the world. Bronchial asthma suffers from 4 to 10% of the world population, in Russian Federation, the incidence of BA across the adult population ranges from 2.2 to 5-7%, in the child population is about 10%.
Severe BA is associated not only with frequent hospitalizations and increased mortality but also with high treatment costs.
As to it, there is a hot button issue of developing new drugs for treating patients not to be achieved effectively with standard therapy. 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. These anti-IgE antibodies effects have been shown in various studies.
One of these drugs is оmalizumab (Xolair®). The drug has been approved in various countries across the world, including the United States and the European Union for the severe allergic BA and chronic idiopathic urticaria treatment. In the Russian Federation, omalizumab was registered in May 2007.
The drug GNR-044 (JSC "GENERIUM", Russian Federation) is biosimilar to the original drug Xolair®. This study is aimed to compare the safety and pharmacokinetics of the drug GNR-044 (JSC "GENERIUM", Russian Federation) and the drug Xolair® in order to register of the drug GNR-044 (JSC "GENERIUM", Russian Federation), a lyophilizate for subcutaneous administration, in the Russian Federation.
- Conditions
- Healthy Volunteers
- Being tested
- Omalizumab (JSC "GENERIUM", the Russian Federation), Xolair® (Novartis Pharma AG, Switzerland)
- Keywords
- omalizumab, humanized monoclonal antibodies, total or free IgE, pharmacokinetics, pharmacodynamics, safety, bronchial asthma, health volunteers, equivalence, biosimilar, anti-allergic agents, anti-asthmatic agents, respiratory system agents, hypersensitivity, immune system diseases, urticaria
- Medical subject headings
- Asthma, Hypersensitivity, Immune System Diseases, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab (JSC "GENERIUM", the Russian Federation)Biological
Also called omalizumab, GNR-044
150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area
Xolair® (Novartis Pharma AG, Switzerland)Biological
Also called omalizumab
150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area
| Study group | Role | What they receive |
|---|---|---|
| GNR-044 (JSC "GENERIUM", the Russian Federation) | Experimental | 150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area Receives: Biological: Omalizumab (JSC "GENERIUM", the Russian Federation) |
| Xolair® (Novartis Pharma AG, Switzerland) | Active comparator | 150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area Receives: Biological: Xolair® (Novartis Pharma AG, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the pharmacokinetic parameter - Tmax
Tmax - Time to reach maximum concentration (day)
Measured: 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
Assessment of the pharmacokinetic parameters - Cmax
Cmax - Maximum concentration (μg / ml)
Measured: 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
Assessment of the pharmacokinetic parameters - AUC0-∞
AUC0-∞ - Area under the concentration-time curve (mgday / ml) in the time interval from 0 to ∞
Measured: 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
Assessment of the pharmacokinetic parameters - AUC0-2016 h
AUC0-2016 h - Area under the concentration-time curve (mg day / ml) in the time interval from 0 to 2016 h
Measured: 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
Assessment of the pharmacokinetic parameters - Kel
Kel - Elimination constant (day - 1)
Measured: 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
Assessment of the pharmacokinetic parameters - Vd/F
Vd/F - Apparent volume of distribution (l)
Measured: 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
Assessment of the pharmacokinetic parameters - CL/F
CL/F - Apparent systemic clearance (ml / day)
Measured: 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
Assessment of the pharmacokinetic parameters - T1/2
T1/2 - Half-life (day)
Measured: 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
Assessment of the pharmacodynamics parameters - AUEC
AUEC - (area under efficacy curve) the area under the curve "Relative difference in the free IgE concentration compared to the initial value - time"
Measured: 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
Assessment of the pharmacodynamics parameters - Cmax
Cmax - Maximum relative difference in free IgE concentration compared to baseline
Measured: 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
Assessment of the pharmacodynamics parameters - relative difference estimation in free IgE concentration at each measurement point compared to baseline
- relative difference estimation in free IgE concentration at each measurement point compared to baseline
Measured: 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
Secondary outcomes (12)
The frequency of antidrug antibodies formation
The frequency of antidrug antibodies formation
Measured: Before drug administration, on Day 15 ± 1 day, Day 42 ± 2 days and Day 85 ± 2 days after drug administration
Antidrug antibody rate
Antidrug antibody rate
Measured: Before drug administration, on Day 15 ± 1 day, Day 42 ± 2 days and Day 85 ± 2 days after drug administration
Neutralising antibodies rate
Neutralising antibodies rate
Measured: Before drug administration, on Day 15 ± 1 day, Day 42 ± 2 days and Day 85 ± 2 days after drug administration
Body temperature measurement
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE: - body temperature measurement
Measured: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Systolic blood pressure
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE: - systolic blood pressure
Measured: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Diastolic blood pressure
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE: - diastolic blood pressure
Measured: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Heart rate
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE: - heart rate
Measured: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Respiratory rate
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE: - respiratory rate
Measured: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Electrocardiogram (ECG) assessment of RR Interval
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE - ECG RR Interval
Measured: Before drug administration, on Day 29, 85 after drug administration
Electrocardiogram (ECG) assessment of PQ Interval
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE - ECG PQ Interval
Measured: Before drug administration, on Day 29, 85 after drug administration
Electrocardiogram (ECG) assessment of QRS Interval
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE - ECG QRS Interval
Measured: Before drug administration, on Day 29, 85 after drug administration
Electrocardiogram (ECG) assessment of QT Interval
A medical examination by an investigator to determine the state of a person's health, identify risk factors for AE and SAE - ECG QT Interval
Measured: Before drug administration, on Day 29, 85 after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start18 Apr 2017
- Primary completion6 Sep 2017
- Study completion6 Sep 2017
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
- Model description
- Interventional
- Masking
- None (open label)
- Enrolment
- 84 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, Head of the scientific department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601389
- Sponsor's protocol ID
- OMA-HVL-I
- Other IDs
- №88 eff.data 16 Feb 2017
- Acronym
- NAP
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NAP
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, in Parallel Groups Comparative Study of Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Omalizumab (JSC "GENERIUM", Russia) and Xolair® ("Novartis Pharma AG", Switzerland) After Single-dose Subcutaneous Administration in Healthy Volunteers at 150 mg
- ClinicalTrials.gov ID
- NCT04601389
- Acronym / sponsor ID
- NAP / OMA-HVL-I
- Conditions
- Healthy Volunteers
- Keywords
- omalizumab, humanized monoclonal antibodies, total or free IgE, pharmacokinetics, pharmacodynamics, safety, bronchial asthma, health volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 6 Sep 2017 (actual)
- First posted
- 23 Oct 2020 (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.
An open-label, randomized, in parallel groups comparative study of pharmacokinetics, pharmacodynamics, immunogenicity and safety of GNR-044 (JSC "GENERIUM", Russian Federation) and Xolair® ("Novartis Pharma AG", Switzerland) after single subcutaneous administration in healthy volunteers at 150 mg
Detailed description
There is an increasing incidence of bronchial asthma (BA) and other allergic diseases around the world. Bronchial asthma suffers from 4 to 10% of the world population, in Russian Federation, the incidence of BA across the adult population ranges from 2.2 to 5-7%, in the child population is about 10%.
Severe BA is associated not only with frequent hospitalizations and increased mortality but also with high treatment costs.
As to it, there is a hot button issue of developing new drugs for treating patients not to be achieved effectively with standard therapy. 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. These anti-IgE antibodies effects have been shown in various studies.
One of these drugs is оmalizumab (Xolair®). The drug has been approved in various countries across the world, including the United States and the European Union for the severe allergic BA and chronic idiopathic urticaria treatment. In the Russian Federation, omalizumab was registered in May 2007.
The drug GNR-044 (JSC "GENERIUM", Russian Federation) is biosimilar to the original drug Xolair®. This study is aimed to compare the safety and pharmacokinetics of the drug GNR-044 (JSC "GENERIUM", Russian Federation) and the drug Xolair® in order to register of the drug GNR-044 (JSC "GENERIUM", Russian Federation), a lyophilizate for subcutaneous administration, in the Russian Federation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| GNR-044 (JSC "GENERIUM", the Russian Federation) | Experimental | Biological: Omalizumab (JSC "GENERIUM", the Russian Federation)150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area |
| Xolair® (Novartis Pharma AG, Switzerland) | Active comparator | Biological: Xolair® (Novartis Pharma AG, Switzerland)150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women between the ages of 18 and 50 (inclusive) at the time of the Informed Consent Form.
- The diagnosis is "healthy" according to haematology and biochemical blood tests, urinalysis, results of physical examination, measurements of vital signs, results of electrocardiography.
- Bodyweight from 40 to 90 kg inclusive.
- Body mass index 18.5-30 kg / m2 inclusive.
- Initial concentration of total IgE: ≥30 IU / ml and ≤300 IU / ml.
Key exclusion criteria (8 listed)
- Monoclonal antibodies administration within 1 year before taking omalizumab.
- Hypersensitivity to any of the used study drug, to their components, history of an undesirable drug reaction.
- Concurrent diseases and conditions with potential impact on the patient's safety, pharmacokinetics or pharmacodynamics.
- The drug's use that affects pharmacokinetics or pharmacodynamics (injectable glucocorticosteroid drugs, allergen-specific immunotherapy, immunosuppressive drugs, vaccination within 30 days before signing informed consent and/or the need for vaccination during the study period).
- Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding.
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 |
|---|---|---|
| Omalizumab (JSC "GENERIUM", the Russian Federation)Also: omalizumab, GNR-044150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area | Biological | GNR-044 (JSC "GENERIUM", the Russian Federation) |
| Xolair® (Novartis Pharma AG, Switzerland)Also: omalizumab150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area | Biological | Xolair® (Novartis Pharma AG, Switzerland) |
Primary outcome
Assessment of the pharmacokinetic parameter - Tmax
Time frame: 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
Tmax - Time to reach maximum concentration (day)
Assessment of the pharmacokinetic parameters - Cmax
Time frame: 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
Cmax - Maximum concentration (μg / ml)
Assessment of the pharmacokinetic parameters - AUC0-∞
Time frame: 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
AUC0-∞ - Area under the concentration-time curve (mgday / ml) in the time interval from 0 to ∞
Assessment of the pharmacokinetic parameters - AUC0-2016 h
Time frame: 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
AUC0-2016 h - Area under the concentration-time curve (mg day / ml) in the time interval from 0 to 2016 h
Assessment of the pharmacokinetic parameters - Kel
Time frame: 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
Kel - Elimination constant (day - 1)
Assessment of the pharmacokinetic parameters - Vd/F
Time frame: 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
Vd/F - Apparent volume of distribution (l)
Assessment of the pharmacokinetic parameters - CL/F
Time frame: 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
CL/F - Apparent systemic clearance (ml / day)
Assessment of the pharmacokinetic parameters - T1/2
Time frame: 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
T1/2 - Half-life (day)
Assessment of the pharmacodynamics parameters - AUEC
Time frame: 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
AUEC - (area under efficacy curve) the area under the curve "Relative difference in the free IgE concentration compared to the initial value - time"
Assessment of the pharmacodynamics parameters - Cmax
Time frame: 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
Cmax - Maximum relative difference in free IgE concentration compared to baseline
Assessment of the pharmacodynamics parameters - relative difference estimation in free IgE concentration at each measurement point compared to baseline
Time frame: 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
• relative difference estimation in free IgE concentration at each measurement point compared to baseline
12 secondary outcomes
The frequency of antidrug antibodies formation
Time frame: Before drug administration, on Day 15 ± 1 day, Day 42 ± 2 days and Day 85 ± 2 days after drug administration
Antidrug antibody rate
Time frame: Before drug administration, on Day 15 ± 1 day, Day 42 ± 2 days and Day 85 ± 2 days after drug administration
Neutralising antibodies rate
Time frame: Before drug administration, on Day 15 ± 1 day, Day 42 ± 2 days and Day 85 ± 2 days after drug administration
Body temperature measurement
Time frame: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Systolic blood pressure
Time frame: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Diastolic blood pressure
Time frame: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Heart rate
Time frame: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Respiratory rate
Time frame: Before drug administration, on Day 1-7, 11, 15, 22, 29, 42, 57, 71, 85 after drug administration
Electrocardiogram (ECG) assessment of RR Interval
Time frame: Before drug administration, on Day 29, 85 after drug administration
Electrocardiogram (ECG) assessment of PQ Interval
Time frame: Before drug administration, on Day 29, 85 after drug administration
Electrocardiogram (ECG) assessment of QRS Interval
Time frame: Before drug administration, on Day 29, 85 after drug administration
Electrocardiogram (ECG) assessment of QT Interval
Time frame: Before drug administration, on Day 29, 85 after drug administration
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 23 Oct 2020.
- Clinical Trials RegisterLink provided by the sponsor.
- Individual participant dataSharing planned: No. NAP
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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
Head of the scientific department
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 Omalizumab (JSC "GENERIUM", the Russian Federation) and Xolair® (Novartis Pharma AG, Switzerland) 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 6 inclusion and 8 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 23 Oct 2020. 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?
Assessment of the pharmacokinetic parameter - Tmax (time frame: 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). The study lists 11 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 23 Oct 2020.