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An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola

NCT03428347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-11-14

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

GamEMab

drug for emergency prevention of Ebola based on recombinant monoclonal antibodies

Sponsors & Collaborators

  • Research Institute of Influenza, Sankt-Peterburg, Russian Federation

    collaborator UNKNOWN

  • Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

    lead OTHER

Principal Investigators

  • Dmitry Lyoznov, MD, PhD · Research Institute of Influenza, Sankt-Peterburg, Russian Federation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-12
Primary Completion
2018-12-29
Completion
2018-12-29

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428347 on ClinicalTrials.gov