An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola

NCT03428347 | Completed Phase 1

• 1 other identifier: 03-AT-2017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Ebola; Ebola Virus Disease; Monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Determination of Number of Participants With Adverse Events

  through the whole study, an average of 90 days

Secondary Outcomes (3)

• Number of Participants With Serious Adverse Events

  through the whole study, an average of 90 days

• Number of Participants with Solicited Local and Systemic Adverse Events

  through the whole study, an average of 90 days

• Pharmacokinetics Study

  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.

Study Arms (3)

Group 1

EXPERIMENTAL

1.4 mg/kg body weight

Biological: GamEMab

Group 2

EXPERIMENTAL

7 mg/kg body weight

Biological: GamEMab

Group 3

EXPERIMENTAL

14 mg/kg body weight

Biological: GamEMab

Interventions

GamEMab BIOLOGICAL

drug for emergency prevention of Ebola based on recombinant monoclonal antibodies

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation: lead
• Research Institute of Influenza, Sankt-Peterburg, Russian Federation: collaborator

Study Sites (1)

Research Institute of Influenza

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Dmitry Lyoznov, MD, PhD

  Research Institute of Influenza, Sankt-Peterburg, Russian Federation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 9, 2018
• Study Start: March 12, 2018
• Primary Completion: December 29, 2018
• Study Completion: December 29, 2018
• Last Updated: November 14, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)