Phase 2 study of the prophylactic antiviral activity of Neumifil in an influenza challenge model
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, Phase 2 study to assess the safety, tolerability, and prophylactic antiviral activity against influenza of Neumifil via a human viral challenge model in healthy adult participants.
IRAS ID
1005885
Contact name
Samantha Yuille
Contact email
Sponsor organisation
Pneumagen Limited
Eudract number
2022-001853-22
Clinicaltrials.gov Identifier
Research summary
This is a single-centre, randomised, double-blind, placebo-controlled, proof-of-concept study in healthy adult male and female participants from 18 to 55 years of age, inclusive. The primary goal of this Phase 2 study is to assess the pre-exposure prophylactic (intended to prevent disease) antiviral activity against influenza, and the safety and tolerability of Neumifil via a human viral challenge model.
Each participant will receive one of 3 treatments:
• Neumifil once daily for 3 days on Days -3 to -1 (multiple dose active treatment).
• A single dose of Neumifil on Day -3 and placebo once daily on Days -2 and -1 (single dose active treatment).
• Placebo once daily for 3 days on Days -3 to -1.
A total of up to 100 participants is planned to be enrolled in this study: 30 participants on multiple dose active treatment, 30 participants on single dose active treatment, and 40 participants on placebo.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0223
Date of REC Opinion
28 Jul 2022
REC opinion
Further Information Favourable Opinion