Status:
COMPLETED
An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola
Lead Sponsor:
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Collaborating Sponsors:
Research Institute of Influenza, Sankt-Peterburg, Russian Federation
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 si...
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 re...
Eligibility Criteria
Inclusion
- 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);
- 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
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03428347
Start Date
March 12 2018
End Date
December 29 2018
Last Update
November 14 2019
Active Locations (1)
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1
Research Institute of Influenza
Saint Petersburg, Russia