Ebola Virus DiseasePhase 1NCT04717830
An Open Study of the Safety and Pharmacokinetics of a Drug for the Emergency Prevention of Ebola Virus Disease
A Phase 1 study testing Gamezumab in people with Ebola Virus Disease, run by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation at 1 site in Russia.
Trial summary
Open-label safety, tolerability, pharmacokinetics and immunogenicity study in three dose escalation groups Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Gamezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteRussia
- Study dates
- 15 Feb 2021to 31 Jan 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -• Availability of written Informed Consent to participate in the research;
- Men and women between the ages of 18 and 45;
- Absence in the history, as well as according to the screening examination of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, blood, which can affect the safety of the volunteer and the assessment of the research results (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant abnormalities);
- Consent to use effective contraceptive methods during the entire period of participation in the study
- Body mass index (BMI) is 18.5≤ BMI≤30;
- Absence of acute infectious diseases at the time of drug administration and 14 days before drug administration;
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- Absence of allergic diseases in anamnesis
- No history of pronounced complications from previous use of immunobiological drugs;
- Negative pregnancy test based on urine test results (for women of childbearing age);
- Negative tests for HIV, hepatitis B and C, syphilis;
- Negative test for the presence of drugs and psychostimulants in the urine;
- Negative test for alcohol content;
- Indicators of general and biochemical analysis of blood, immunoglobulin E at screening within 1.1 X upper limit of the reference interval- 0.9 X lower limit of the reference interval
- Absence of changes in the myocardium of an inflammatory or dystrophic nature according to the results of ECG at screening
Who cannot join
- Participation of a volunteer in any other research within the last 90 days;
- Acute infectious and non-infectious diseases, exacerbations of chronic diseases during the 4 weeks preceding the screening;
- Vaccination against Ebola virus disease with any drugs, or administration of monoclonal antibodies against Ebola virus disease, including in the course of other clinical trials
- Treatment with steroids (except for hormonal contraceptives) in the last 10 days;
- Administration of immunoglobulins or other blood products in the last 3 months;
- Taking immunosuppressive drugs and / or immunomodulators within 6 months before the start of the study;
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- Pregnancy or breastfeeding;
- Systolic blood pressure less than 100 mm Hg. or above 139 mm Hg; diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg; heart rate less than 60 beats / min or more than 100 beats / min;
- Aggravated allergic anamnesis (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, a history of serum sickness, hypersensitivity or allergic reactions to the administration of immunobiological drugs, known allergic reactions to the drug components, etc.), IgE total at the screening visit more than 2x upper limit of the reference interval;
- Diabetes mellitus or other forms of impaired glucose tolerance;
- The presence of a concomitant disease that may affect the assessment of the study results or which, in the opinion of the researcher, will not allow the volunteer to participate in the study or may affect the study and / or its results (including the assessment of safety parameters);
- A history of malignant neoplasms;
- Donation of blood (450 ml or more of blood or plasma) less than 2 months before the start of the study;
- Taking narcotic and psychostimulating drugs at the present time or in history;
- Alcohol intake in excess of the low risk level: no more than 20 grams of pure alcohol per day, no more than 5 days a week, alcohol intake within 48 hours before the administration of the study drug;
- Smoking: more than 10 cigarettes a day;
- Planned hospitalization and / or surgical intervention during the period of participation in the study, as well as 4 weeks before the expected date of drug administration.
- The presence of a concomitant disease that may affect the assessment of research results
- The volunteer's weight is less than 45 and more than 100 kg (even if the BMI of the volunteer meets the norm - clause 5 of the inclusion criteria)
- Any condition that, in the opinion of the investigator's physician, may be a contraindication to participation in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Research Institute of Influenza
Saint Petersburg
Tatiana Zubkova, MD, PhD, +7 812 499-15-00 ext. 812, office@influenza.spb.ru
About this study
Official title: An Open Study of the Safety and Pharmacokinetics of a Drug for the Emergency Prevention of Ebola Virus Disease Based on Humanized Monoclonal Antibodies
Open-label safety, tolerability, pharmacokinetics and immunogenicity study in three dose escalation groups
Read the detailed description
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.
The study will include volunteers of both sexes, aged 18 to 45 years inclusive. Only 25 people will take part in the study and will receive the study drug, of which 5 will receive 1/10 of the therapeutic dose, 5 - 1/2 of the therapeutic dose, 15 - in the full therapeutic dose.
Participation of 5 doubles is envisaged: 1 person for a group of 5 volunteers and 3 for 15.
- Conditions
- Ebola Virus Disease
- Being tested
- Gamezumab
- 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.
GamezumabDrug
Also called monoclonal antibodies against Ebola virus disease
solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Gamezumab 1/10 therapeutic dose | Experimental | 1/10 therapeutic dose (5 volunteers) Receives: Drug: Gamezumab |
| Gamezumab 1/2 therapeutic dose | Experimental | 1/2 therapeutic dose (5 volunteers) Receives: Drug: Gamezumab |
| Gamezumab full therapeutic dose | Experimental | therapeutic dose (10 volunteers) Receives: Drug: Gamezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (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 posted22 Jan 2021
- Study start15 Feb 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Virus DiseaseStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tatiana Zubkova, Principal investigator, Research Institute of Influenza, Sankt-Peterburg, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717830
- Sponsor's protocol ID
- 01-AT-2020
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 18 Feb 2021
- 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 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study of the Safety and Pharmacokinetics of a Drug for the Emergency Prevention of Ebola Virus Disease Based on Humanized Monoclonal Antibodies
- ClinicalTrials.gov ID
- NCT04717830
- Acronym / sponsor ID
- 01-AT-2020
- Conditions
- Ebola Virus Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 22 Jan 2021 (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.
Open-label safety, tolerability, pharmacokinetics and immunogenicity study in three dose escalation groups
Detailed description
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.
The study will include volunteers of both sexes, aged 18 to 45 years inclusive. Only 25 people will take part in the study and will receive the study drug, of which 5 will receive 1/10 of the therapeutic dose, 5 - 1/2 of the therapeutic dose, 15 - in the full therapeutic dose.
Participation of 5 doubles is envisaged: 1 person for a group of 5 volunteers and 3 for 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gamezumab 1/10 therapeutic dose | Experimental | Drug: Gamezumab1/10 therapeutic dose (5 volunteers) |
| Gamezumab 1/2 therapeutic dose | Experimental | Drug: Gamezumab1/2 therapeutic dose (5 volunteers) |
| Gamezumab full therapeutic dose | Experimental | Drug: Gamezumabtherapeutic dose (10 volunteers) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- -• Availability of written Informed Consent to participate in the research;
- Men and women between the ages of 18 and 45;
- Absence in the history, as well as according to the screening examination of pathology from the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system, musculoskeletal system, genitourinary, immune and endocrine systems, blood, which can affect the safety of the volunteer and the assessment of the research results (clinical, instrumental and laboratory studies did not reveal diseases or clinically significant abnormalities);
- Consent to use effective contraceptive methods during the entire period of participation in the study
- Body mass index (BMI) is 18.5≤ BMI≤30;
Key exclusion criteria (20 listed)
- Participation of a volunteer in any other research within the last 90 days;
- Acute infectious and non-infectious diseases, exacerbations of chronic diseases during the 4 weeks preceding the screening;
- Vaccination against Ebola virus disease with any drugs, or administration of monoclonal antibodies against Ebola virus disease, including in the course of other clinical trials
- Treatment with steroids (except for hormonal contraceptives) in the last 10 days;
- Administration of immunoglobulins or other blood products in the last 3 months;
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 |
|---|---|---|
| GamezumabAlso: monoclonal antibodies against Ebola virus diseasesolution for infusion | Drug | Gamezumab 1/10 therapeutic dose, Gamezumab 1/2 therapeutic dose, Gamezumab full therapeutic dose |
Primary outcome
Number of Participants With Serious Adverse Events
Time frame: through the whole study, an average of 90 days
Determination of Number of Participants With Serious Adverse Events
Number of Participants with Solicited Local and Systemic Adverse Events
Time frame: through the whole study, an average of 90 days
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
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.
Immunological methods will be used to study the level of specific antibodies (ELISA)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- 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.
Tatiana Zubkova 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 Gamezumab in people with Ebola Virus Disease, 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 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Shcheblyakov (1933001, info@gamaleya.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (time frame: through the whole study, an average of 90 days). The study lists 3 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 18 Feb 2021.