NCT05507567

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Pneumagen Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Influenza Viral Infections

Interventions

Type	Name	Description
DRUG	Neumifil	Liquid for intranasal spray administration
DRUG	Placebo	Liquid for intranasal spray administration

Timeline

• Start date: 2022-08-12
• Primary completion: 2023-05-04
• Completion: 2023-05-04
• First posted: 2022-08-19
• Last updated: 2024-10-28
• Results posted: 2024-10-28

Locations

1 site across 1 country: United Kingdom