An Open Study of the Safety and Pharmacokinetics of a Drug for the Emergency Prevention of Ebola Virus Disease

February 17, 2021 updated by: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-• 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;
  • 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

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Gamezumab 1/10 therapeutic dose
1/10 therapeutic dose (5 volunteers)
Drug: Gamezumab
solution for infusion
Other Names:
  • monoclonal antibodies against Ebola virus disease
Experimental: Gamezumab 1/2 therapeutic dose
1/2 therapeutic dose (5 volunteers)
Drug: Gamezumab
solution for infusion
Other Names:
  • monoclonal antibodies against Ebola virus disease
Experimental: Gamezumab full therapeutic dose
therapeutic dose (10 volunteers)
Drug: Gamezumab
solution for infusion
Other Names:
  • monoclonal antibodies against Ebola virus disease

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Determination of Number of Participants with Solicited Local and Systemic Adverse Events
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.
Immunological methods will be used to study the level of specific antibodies (ELISA)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tatiana Zubkova, Research Institute of Influenza, Sankt-Peterburg, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01-AT-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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