HealthyPhase 103-AT-2017NCT03428347
An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola
A Phase 1 study testing GamEMab in people with Healthy, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
This Phase I clinical trial was developed to study drug safety, tolerability, and pharmacokinetics of the medicine for Ebola fever emergency prevention based on monoclonal recombinant antibodies in single use in healthy volunteers with a dose escalation. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GamEMab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- 12 Mar 2018to 29 Dec 2018
- 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
- men and women aged 18 to 45 years;
- written informed consent;
- consent to use of effective contraception methods during the whole period of participation in the study; (using one of the following methods: abstinence, condoms (male or female with or without spermicide), diaphragm or cervical cap with a spermicidal tool, intrauterine device);
- body mass index (BMI) is 18.5 ≤ BMI ≤ 30;
- absence of acute infections/exacerbations of chronic at the time of participation in the study and for 7 days before initiation of therapy;
- absence of allergic disease severe disease (anaphylaxis, angioedema, polymorphic exudative eczema, serum sickness);
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- no history of severe complications in a previous application of immunobiological preparations;
- lack of history, but also according to screening tests, pathology of the gastrointestinal tract, liver, kidneys, cardiovascular system, Central nervous system, musculoskeletal, urogenital and endocrine systems that can influence the evaluation of the results of the study;
- negative pregnancy test blood or urine (for women of childbearing age) not more than 24 hours before receiving the first dose of study drug;
- negative tests for HIV, hepatitis b and C, syphilis;
- negative urine test for drug traces;
- negative test for alcohol content in breath;
- absence of malignant blood diseases;
- absence of malignant tumors;
- negative allergological study on the epithelium and the proteins of the mouse.
- anti-mouse antibody titer less than 1:500;
- indicators of the General analysis of blood, biochemical analysis of blood total IgE at screening within the normal values.
- ( will be provided normal reference values of the laboratory performing the study)
- no history of previous vaccination against Ebola, including during clinical studies
Who cannot join
- volunteer participation in any other clinical trial within the last 90 days;
- respiratory symptoms in the last 3 days;
- treatment with steroids for the last 10 days (excluding preparations for intranasal administration and topical application);
- allergic reactions to proteins/epithelium of the mouse in history or about the results of laboratory studies on the screening, the titer of anti-mouse antibodies according to the study of 1:500 and more; introduction immunoglobulins or other blood products within the last 6 months;
- treatment with immunosuppressive drugs and/or immunomodulators within 6 months prior to the study;
- the use of other drugs based on murine monoclonal antibodies in history;
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- regular past or current use of narcotic drugs;
- pregnancy or breast-feeding;
- systolic blood pressure less than 100 mm of mercury.St. or above 139 mm Hg.St; diastolic blood pressure less than 60 mm of mercury.St. or higher 90 mm. Hg.St.; heart rate less than 60 beats/min or more than 90 beats/min;
- aggravation of allergic diseases, the presence of anaphylactic reactions or angioedema in history;
- allergic reactions to the drug components;
- the presence of comorbid disease that may influence the assessment of the research results: active tuberculosis, chronic diseases of the liver and kidneys, expressed violations of function of thyroid gland and other endocrine system diseases (diabetes), severe diseases of the hematopoietic system, epilepsy and other diseases of the Central nervous system, myocardial infarction in anamnesis, myocarditis, endocarditis, pericarditis, ischemic heart disease, autoimmune disorders, severe chronic diseases that require hospital observation, and other diseases according to the researcher, will not allow the volunteer to participate in the study or may influence the research and/or its results (including the valuation of security);
- donating blood (450 ml blood or plasma, and more) in less than 2 months before the study;
- receiving history more than 5 units (0.25 l of ethanol) of alcohol per week;
- Smoking more than 10 cigarettes per day;
- planned hospitalization and/or surgical intervention during participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Dose Escalation Safety and Pharmacokinetics Study of the Medicine for Ebola Fever Emergency Prevention Based on Monoclonal Recombinant Antibodies With a Single Application in 3 Groups of Healthy Volunteers
This Phase I clinical trial was developed to study drug safety, tolerability, and pharmacokinetics of the medicine for Ebola fever emergency prevention based on monoclonal recombinant antibodies in single use in healthy volunteers with a dose escalation. A consecutive recruitment of people who signed the Informed Consent Form into three groups of volunteers with different drug doses is made according to the volunteers' screening results. The total number of volunteers receiving the drug will be not less then 25 people.The purpose of this study is to assess safety, tolerability, and pharmacokinetics of a medicine for Ebola fever emergency prevention based on monoclonal recombinant antibodies in a single dose in healthy volunteers.
Read the detailed description
The results of the screening of volunteers who signed the informed consent Form, is a sequence set in three groups of volunteers with different doses of the drug, the total number of volunteers who received the drug will be at least 25 people.
Taking into account the fact that for the first time the drug is studied on people, initially five volunteers will be hospitalized. Their dose of the studied medicine will be 1.4 mg/kg of weight. After confirmation of safety based on observation results on the 60th day of the study, the investigation will continue with the participation of five more volunteers. Safety will be studied on these five volunteers with a single use of dose of 7 mg/kg of weight.
After an intermediate safety assessment on the 60th day, 15 more volunteers will be included in the study. They will get the medicine with the dose of 14 mg/kg of weight.
If necessary, understudies in an amount of not more than 4 people may be included. Volunteers are replaced before the injection of the medicine. If a volunteer got the medicine, he could not be replaced.
After evaluating the safety analyzes' intermediate results (blood test and blood chemistry, urinalysis, immunological safety, clinical evaluation of general health status) obtained on day 60 of the study, the Researcher, in agreement with the Ethics Committee, makes a decision to include the second group (five people) to study the drug at a dosage of 7 mg/kg of weight. After the evaluation of intermediate safety results on the 60th day of the study of volunteers from the second group, 15 more volunteers will be included in the study. After the intermediate evaluation of safety on the 60th day of study, 15 more volunteers will be included in the study and get the medicine in a dose of 14 mg/kg of weight. Wherein the third part of volunteers is planned to be included consistently: in the beginning 5 volunteers will be included and after the intermediate safety evaluation on the 28th day the rest 10 volunteers will be included in the study.
The safety and tolerability assessment will be based on the registration of adverse events during the study. Changes in instrumental (ECG) and laboratory indicators (blood test and blood chemistry, blood coagulation system indicators, urinalysis, immunological status), dynamics of vital signs (blood pressure, heart rate, body temperature) will be also evaluated.
Pharmacokinetic parameters will be calculated by a model-independent method. Immunological methods (ELISA) will be used for studying the level of specific antibodies and the duration of their circulation in the human body.
Sampling of biological material involves:
Urinalysis: at screening, before administration of the drug after 48 hours and on 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; urine samples for a pregnancy test taken at screening and on the day of hospitalization (in addition to volunteers women).
to define security settings (General clinical and biochemical blood tests, including a study of the coagulation system): at screening, before dosing, 48 hours, and 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; immune status*- the drug, 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; will also be determining the level of specific antibodies to the drug (with detection with the determination of class, subclass, immunoglobulins and assessment of their functional activity) is the drug, 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; **biochemical blood analysis includes a determination of: total protein, urea, creatinine, aspartataminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, glucose, cholesterol, creatine phosphokinase, CRP, concentration of electrolytes (sodium, potassium), coagulation include: PI+, INR, APTT, fibrinogen.
*** evaluation of the immunological status includes: determining the number and relative content of subpopulations of T - and b-lymphocytes (CD3, CD 4, CD 8, CD 16, CD19), phagocytic activity of white blood cells, immunoregulatory index, content of serum immunoglobulins major classes (A, M, G, E), circulating immuno complexes, the detection of antibodies to the mouse immunoglobulin, the content of anti-inflammatory cytokines (TNF-α, ИЛ1, IL-6, IFN-γ).
Blood samples for testing for hepatitis b and C, HIV and syphilis will be taken once at screening visit.
In addition there will be samples of whole blood for analysis of pharmacokinetic parameters: before drug administration, through 1, 4, 8, 24, 36, 48 and 96 hours after drug administration, and 7, 10, 14, 21, 28, 45, 60 and 90 days study.
- Conditions
- Healthy
- Being tested
- GamEMab
- Keywords
- Ebola, Ebola Virus Disease, Monoclonal antibody
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamEMabBiological
drug for emergency prevention of Ebola based on recombinant monoclonal antibodies
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 1.4 mg/kg body weight Receives: Biological: GamEMab |
| Group 2 | Experimental | 7 mg/kg body weight Receives: Biological: GamEMab |
| Group 3 | Experimental | 14 mg/kg body weight Receives: Biological: GamEMab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Determination of Number of Participants With Adverse Events
Measured: through the whole study, an average of 90 days
Secondary outcomes (3)
Number of Participants With Serious Adverse Events
Determination of Number of Participants With Serious Adverse Events
Measured: through the whole study, an average of 90 days
Number of Participants with Solicited Local and Systemic Adverse Events
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Measured: through the whole study, an average of 90 days
Pharmacokinetics Study
Immunological methods will be used to study the level of specific antibodies and the duration of their circulation in the human body (ELISA)
Measured: before drug administration, after 1, 4, 8, 24, 36 and 48 hours after drug administration, and 7, 10, 14, 21, 28, 45, 60 and 90 days study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start12 Mar 2018
- Primary completion29 Dec 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute of Influenza, Sankt-Peterburg, Russian Federation
- Responsible party
- Sponsor
- Investigators
- Dmitry Lyoznov, MD, PhD, Principal investigator, Research Institute of Influenza, Sankt-Peterburg, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428347
- Sponsor's protocol ID
- 03-AT-2017
- Acronym
- 03-AT-2017
- Status last verified
- Dec 2017
- First submitted
- 25 Jan 2018
- Last updated
- 14 Nov 2019
- 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 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose Escalation Safety and Pharmacokinetics Study of the Medicine for Ebola Fever Emergency Prevention Based on Monoclonal Recombinant Antibodies With a Single Application in 3 Groups of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03428347
- Acronym / sponsor ID
- 03-AT-2017 / 03-AT-2017
- Conditions
- Healthy
- Keywords
- Ebola, Ebola Virus Disease, Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Collaborators
- Research Institute of Influenza, Sankt-Peterburg, Russian Federation
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 29 Dec 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 9 Feb 2018 (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 Phase I clinical trial was developed to study drug safety, tolerability, and pharmacokinetics of the medicine for Ebola fever emergency prevention based on monoclonal recombinant antibodies in single use in healthy volunteers with a dose escalation. A consecutive recruitment of people who signed the Informed Consent Form into three groups of volunteers with different drug doses is made according to the volunteers' screening results. The total number of volunteers receiving the drug will be not less then 25 people.The purpose of this study is to assess safety, tolerability, and pharmacokinetics of a medicine for Ebola fever emergency prevention based on monoclonal recombinant antibodies in a single dose in healthy volunteers.
Detailed description
The results of the screening of volunteers who signed the informed consent Form, is a sequence set in three groups of volunteers with different doses of the drug, the total number of volunteers who received the drug will be at least 25 people.
Taking into account the fact that for the first time the drug is studied on people, initially five volunteers will be hospitalized. Their dose of the studied medicine will be 1.4 mg/kg of weight. After confirmation of safety based on observation results on the 60th day of the study, the investigation will continue with the participation of five more volunteers. Safety will be studied on these five volunteers with a single use of dose of 7 mg/kg of weight.
After an intermediate safety assessment on the 60th day, 15 more volunteers will be included in the study. They will get the medicine with the dose of 14 mg/kg of weight.
If necessary, understudies in an amount of not more than 4 people may be included. Volunteers are replaced before the injection of the medicine. If a volunteer got the medicine, he could not be replaced.
After evaluating the safety analyzes' intermediate results (blood test and blood chemistry, urinalysis, immunological safety, clinical evaluation of general health status) obtained on day 60 of the study, the Researcher, in agreement with the Ethics Committee, makes a decision to include the second group (five people) to study the drug at a dosage of 7 mg/kg of weight. After the evaluation of intermediate safety results on the 60th day of the study of volunteers from the second group, 15 more volunteers will be included in the study. After the intermediate evaluation of safety on the 60th day of study, 15 more volunteers will be included in the study and get the medicine in a dose of 14 mg/kg of weight. Wherein the third part of volunteers is planned to be included consistently: in the beginning 5 volunteers will be included and after the intermediate safety evaluation on the 28th day the rest 10 volunteers will be included in the study.
The safety and tolerability assessment will be based on the registration of adverse events during the study. Changes in instrumental (ECG) and laboratory indicators (blood test and blood chemistry, blood coagulation system indicators, urinalysis, immunological status), dynamics of vital signs (blood pressure, heart rate, body temperature) will be also evaluated.
Pharmacokinetic parameters will be calculated by a model-independent method. Immunological methods (ELISA) will be used for studying the level of specific antibodies and the duration of their circulation in the human body.
Sampling of biological material involves:
Urinalysis: at screening, before administration of the drug after 48 hours and on 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; urine samples for a pregnancy test taken at screening and on the day of hospitalization (in addition to volunteers women).
to define security settings (General clinical and biochemical blood tests, including a study of the coagulation system): at screening, before dosing, 48 hours, and 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; immune status*- the drug, 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; will also be determining the level of specific antibodies to the drug (with detection with the determination of class, subclass, immunoglobulins and assessment of their functional activity) is the drug, 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; **biochemical blood analysis includes a determination of: total protein, urea, creatinine, aspartataminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, glucose, cholesterol, creatine phosphokinase, CRP, concentration of electrolytes (sodium, potassium), coagulation include: PI+, INR, APTT, fibrinogen.
*** evaluation of the immunological status includes: determining the number and relative content of subpopulations of T - and b-lymphocytes (CD3, CD 4, CD 8, CD 16, CD19), phagocytic activity of white blood cells, immunoregulatory index, content of serum immunoglobulins major classes (A, M, G, E), circulating immuno complexes, the detection of antibodies to the mouse immunoglobulin, the content of anti-inflammatory cytokines (TNF-α, ИЛ1, IL-6, IFN-γ).
Blood samples for testing for hepatitis b and C, HIV and syphilis will be taken once at screening visit.
In addition there will be samples of whole blood for analysis of pharmacokinetic parameters: before drug administration, through 1, 4, 8, 24, 36, 48 and 96 hours after drug administration, and 7, 10, 14, 21, 28, 45, 60 and 90 days study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: GamEMab1.4 mg/kg body weight |
| Group 2 | Experimental | Biological: GamEMab7 mg/kg body weight |
| Group 3 | Experimental | Biological: GamEMab14 mg/kg body weight |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- men and women aged 18 to 45 years;
- written informed consent;
- consent to use of effective contraception methods during the whole period of participation in the study; (using one of the following methods: abstinence, condoms (male or female with or without spermicide), diaphragm or cervical cap with a spermicidal tool, intrauterine device);
- body mass index (BMI) is 18.5 ≤ BMI ≤ 30;
- absence of acute infections/exacerbations of chronic at the time of participation in the study and for 7 days before initiation of therapy;
Key exclusion criteria (16 listed)
- volunteer participation in any other clinical trial within the last 90 days;
- respiratory symptoms in the last 3 days;
- treatment with steroids for the last 10 days (excluding preparations for intranasal administration and topical application);
- allergic reactions to proteins/epithelium of the mouse in history or about the results of laboratory studies on the screening, the titer of anti-mouse antibodies according to the study of 1:500 and more; introduction immunoglobulins or other blood products within the last 6 months;
- treatment with immunosuppressive drugs and/or immunomodulators within 6 months prior to 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 |
|---|---|---|
| GamEMabdrug for emergency prevention of Ebola based on recombinant monoclonal antibodies | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Number of Participants With Adverse Events
Time frame: through the whole study, an average of 90 days
Determination of Number of Participants With Adverse Events
3 secondary outcomes
Number of Participants With Serious Adverse Events
Time frame: through the whole study, an average of 90 days
Number of Participants with Solicited Local and Systemic Adverse Events
Time frame: through the whole study, an average of 90 days
Pharmacokinetics Study
Time frame: before drug administration, after 1, 4, 8, 24, 36 and 48 hours after drug administration, and 7, 10, 14, 21, 28, 45, 60 and 90 days study.
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 14 Nov 2019.
- 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.
Dmitry Lyoznov, MD, PhD principal investigator
Research Institute of Influenza, Sankt-Peterburg, Russian Federation
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 GamEMab in people with Healthy, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation 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 19 inclusion and 16 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 14 Nov 2019. 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?
Number of Participants With Adverse Events (time frame: through the whole study, an average of 90 days). 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 14 Nov 2019.