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drugset / Trial / NCT03428347

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

NCT03428347 ↗

Phase 1 Completed 25 enrolled Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation Research Institute of Influenza, Sankt-Peterburg, Russian Federation · collab
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject GamEMab Monoclonal antibody 1.4 mg/kg —
Subject GamEMab Monoclonal antibody 7 mg/kg —
Subject GamEMab Monoclonal antibody 14 mg/kg —

Indications

No indication recorded.