NCT04717830

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
DRUG	Gamezumab	solution for infusion

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-12-31
• Completion: 2022-01-31
• First posted: 2021-01-22
• Last updated: 2021-02-18

Locations

1 site across 1 country: Russia