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Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model

Influenza Viral Infections Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 2a Study To Assess the Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza, Via a Human Viral Challenge Model in Healthy Adult Participants

Clinical Trial Summary

Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants

Clinical Trial Description

This is a single-centre, randomized, double-blind, placebo-controlled study in healthy adult participants to assess the pre-exposure prophylactic antiviral activity of Neumifil via a human viral challenge model. Participants will enter the quarantine unit on Day -4. Participants will be randomized to receive either active (single dose), active (multiple dose) or placebo in a 3:3:4 ratio followed by influenza viral challenge on Day 0. Participants will leave the unit on Day 8, provided that no virus is detected by a qualitative virus antigen test and the participant has no clinically significant symptoms. A final follow-up will be performed on Day 28. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05507567
Study type Interventional
Source Pneumagen Ltd.
Contact
Status Completed
Phase Phase 2
Start date August 12, 2022
Completion date May 4, 2023
View Details
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