NCT04717830

Brief Summary

Open-label safety, tolerability, pharmacokinetics and immunogenicity study in three dose escalation groups

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 18, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 15, 2021

Last Update Submit

February 17, 2021

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Serious Adverse Events

    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

    Determination of Number of Participants with Solicited Local and Systemic Adverse Events

    through the whole study, an average of 90 days

  • Pharmacokinetics 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.

Study Arms (3)

Gamezumab 1/10 therapeutic dose

EXPERIMENTAL

1/10 therapeutic dose (5 volunteers)

Drug: Gamezumab

Gamezumab 1/2 therapeutic dose

EXPERIMENTAL

1/2 therapeutic dose (5 volunteers)

Drug: Gamezumab

Gamezumab full therapeutic dose

EXPERIMENTAL

therapeutic dose (10 volunteers)

Drug: Gamezumab

Interventions

GamezumabDRUG

solution for infusion

Also known as: monoclonal antibodies against Ebola virus disease
Gamezumab 1/10 therapeutic doseGamezumab 1/2 therapeutic doseGamezumab full therapeutic dose

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Institute of Influenza

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Study Officials

  • Tatiana Zubkova

    Research Institute of Influenza, Sankt-Peterburg, Russian Federation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Shcheblyakov

CONTACT

1933001info@gamaleya.org

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 15, 2021

First Posted

January 22, 2021

Study Start

February 15, 2021

Primary Completion

December 31, 2021

Study Completion

January 31, 2022

Last Updated

February 18, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)