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An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola (03-AT-2017)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03428347
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
Research Institute of Influenza, Sankt-Peterburg, Russian Federation
Information provided by (Responsible Party):
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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 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.

Condition or disease Intervention/treatment Phase
Healthy Biological: GamEMab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : December 29, 2018
Actual Study Completion Date : December 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arm Intervention/treatment
Experimental: Group 1
1.4 mg/kg body weight
Biological: GamEMab
drug for emergency prevention of Ebola based on recombinant monoclonal antibodies

Experimental: Group 2
7 mg/kg body weight
Biological: GamEMab
drug for emergency prevention of Ebola based on recombinant monoclonal antibodies

Experimental: Group 3
14 mg/kg body weight
Biological: GamEMab
drug for emergency prevention of Ebola based on recombinant monoclonal antibodies




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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 and the duration of their circulation in the human body (ELISA)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428347


Locations
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Russian Federation
Research Institute of Influenza
Sankt-Peterburg, Russian Federation
Sponsors and Collaborators
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Research Institute of Influenza, Sankt-Peterburg, Russian Federation
Investigators
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Principal Investigator: Dmitry Lyoznov, MD, PhD Research Institute of Influenza, Sankt-Peterburg, Russian Federation
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Responsible Party: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
ClinicalTrials.gov Identifier: NCT03428347    
Other Study ID Numbers: 03-AT-2017
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation:
Ebola
Ebola Virus Disease
Monoclonal antibody
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes