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

Ebola Virus Disease Clinical Trial

Official title:
An Open Study of the Safety and Pharmacokinetics of a Drug for the Emergency Prevention of Ebola Virus Disease Based on Humanized Monoclonal Antibodies

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04717830
Study type Interventional
Source Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Contact Dmitry Shcheblyakov
Phone 1933001
Email info@gamaleya.org
Status Recruiting
Phase Phase 1
Start date February 15, 2021
Completion date January 31, 2022
View Details
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