Clinical Trials Logo
NCT number NCT03428347
Study type Interventional
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact Dmitry Sheblyakov, PhD
Phone 193 30 60
Email info@gamaleya.org
Status Not yet recruiting
Phase Phase 1
Start date March 1, 2018
Completion date December 31, 2018

Clinical Trial Summary

The present clinical phase I study designed to examine the safety, tolerability and pharmacokinetics of a medicinal product for emergency prevention of Ebola based on monoclonal recombinant antibodies in a single application in healthy volunteers with dose escalation. 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 received the drug will be at least 25 people.


Clinical Trial 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 received the drug will be at least 25 people.

Given the fact that the drug is investigated for the first time with the participation of the people, will initially be admitted to hospital on 5 volunteers who receive the study drug at a dose of 1.4 mg/kg of body weight. When you confirm the safety of the drug on the results of the observations at the 60-th day of the study, the study will be continued with the participation of 5 other volunteers, which will examine the safety of study drug in a single application at a dosage of 7 mg/kg body weight.

After the intermediate safety assessment for the 60 day study will be included 15 volunteers who receives the drug at a dose of 14 mg/kg of body weight.

Sampling of biological material involves:

Urinalysis: at screening, before administration of the drug after 48 hours and on 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; urine samples for a pregnancy test taken at screening and on the day of hospitalization (in addition to volunteers women).

to define security settings (General clinical and biochemical** blood tests, including a study of the coagulation system): at screening, before dosing, 48 hours, and 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; immune status***- the drug, 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; will also be determining the level of specific antibodies to the drug (with detection with the determination of class, subclass, immunoglobulins and assessment of their functional activity) is the drug, 7, 10, 14, 21, 28, 45, 60 and 90 days of the study; **biochemical blood analysis includes a determination of: total protein, urea, creatinine, aspartataminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin, glucose, cholesterol, creatine phosphokinase, CRP, concentration of electrolytes (sodium, potassium), coagulation include: PI+, INR, APTT, fibrinogen.

*** evaluation of the immunological status includes: determining the number and relative content of subpopulations of T - and b-lymphocytes (CD3, CD 4, CD 8, CD 16, CD19), phagocytic activity of white blood cells, immunoregulatory index, content of serum immunoglobulins major classes (A, M, G, E), circulating immuno complexes, the detection of antibodies to the mouse immunoglobulin, the content of anti-inflammatory cytokines (TNF-α, ИЛ1, IL-6, IFN-γ).

Blood samples for testing for hepatitis b and C, HIV and syphilis will be taken once at screening visit.

In addition there will be samples of whole blood for analysis of pharmacokinetic parameters: before drug administration, through 1, 4, 8, 24, 36, 48 and 96 hours after drug administration, and 7, 10, 14, 21, 28, 45, 60 and 90 days study.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Terminated NCT00001844 - Study of New Magnetic Resonance Methods N/A
Enrolling by invitation NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Recruiting NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Active, not recruiting NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Recruiting NCT03114839 - Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN) N/A
Recruiting NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Recruiting NCT03259464 - This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated Phase 1
Completed NCT03309566 - Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir Phase 4
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Recruiting NCT03277612 - Effects of C-section Delivery on Infant Brain Development N/A
Completed NCT03373162 - Functional Effects of Botox on the Brain Using MRS and fMRI Phase 4
Recruiting NCT02509494 - Staged Phase 3 Study to Assess the Safety and Immunogenicity of Ebola Candidate Vaccines Ad26.ZEBOV and MVA-BN-Filo During Implementation of Stages 1 and 2 Phase 3
Terminated NCT02555085 - Single Ascending Doses of BIIB063 in Healthy Volunteers Phase 1
Completed NCT03125018 - Accuracy of SpO2 for Noninvasive Pulse Oximeter Sensor (LNCS ADTX) N/A
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT00004556 - The Effects of Dextroamphetamine on Brain Function N/A
Completed NCT00091533 - Neural Correlates of Observation of Tactile Stimulation in Healthy Subjects N/A
Completed NCT00068926 - VRC 300: Screening of Healthy Volunteers for Clinical Trials of Investigational Vaccines to Prevent Infectious Diseases N/A
Recruiting NCT03280173 - A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood Phase 1