Clinical Trials Logo

Clinical Trial 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.


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.

Taking into account the fact that for the first time the drug is studied on people, initially five volunteers will be hospitalized. Their dose of the studied medicine will be 1.4 mg/kg of weight. After confirmation of safety based on observation results on the 60th day of the study, the investigation will continue with the participation of five more volunteers. Safety will be studied on these five volunteers with a single use of dose of 7 mg/kg of weight.

After an intermediate safety assessment on the 60th day, 15 more volunteers will be included in the study. They will get the medicine with the dose of 14 mg/kg of weight.

If necessary, understudies in an amount of not more than 4 people may be included. Volunteers are replaced before the injection of the medicine. If a volunteer got the medicine, he could not be replaced.

After evaluating the safety analyzes' intermediate results (blood test and blood chemistry, urinalysis, immunological safety, clinical evaluation of general health status) obtained on day 60 of the study, the Researcher, in agreement with the Ethics Committee, makes a decision to include the second group (five people) to study the drug at a dosage of 7 mg/kg of weight. After the evaluation of intermediate safety results on the 60th day of the study of volunteers from the second group, 15 more volunteers will be included in the study. After the intermediate evaluation of safety on the 60th day of study, 15 more volunteers will be included in the study and get the medicine in a dose of 14 mg/kg of weight. Wherein the third part of volunteers is planned to be included consistently: in the beginning 5 volunteers will be included and after the intermediate safety evaluation on the 28th day the rest 10 volunteers will be included in the study.

The safety and tolerability assessment will be based on the registration of adverse events during the study. Changes in instrumental (ECG) and laboratory indicators (blood test and blood chemistry, blood coagulation system indicators, urinalysis, immunological status), dynamics of vital signs (blood pressure, heart rate, body temperature) will be also evaluated.

Pharmacokinetic parameters will be calculated by a model-independent method. Immunological methods (ELISA) will be used for studying the level of specific antibodies and the duration of their circulation in the human body.

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


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 Recruiting
Phase Phase 1
Start date March 12, 2018
Completion date December 31, 2018

See also
  Status Clinical Trial Phase
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Completed NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Completed 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
Active, not recruiting NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Completed 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
Completed NCT03373162 - Functional Effects of Botox on the Brain Using MRS and fMRI Phase 4
Active, not 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
Not yet recruiting NCT03617861 - Effect of Secretin in Functional Dyspepsia and Healthy Subjects Phase 1/Phase 2
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