Safety and PK of single and repeated doses of Neumifil; Version 1 [COVID-19]
Research type
Research Study
Full title
A two-part, randomised, double-blind, placebo-controlled, ascending dose study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of Neumifil (a novel drug candidate with potential for treatment of COVID-19). (HMR code 20-021)
IRAS ID
299083
Contact name
David Howat
Contact email
Sponsor organisation
Pneumagen Ltd
Eudract number
2021-001946-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Summary of Research
Neumifil™ (the study medicine) is an experimental medicine for preventing infections with certain types of viruses, including the COVID-19 virus and influenza (‘flu’) viruses. Once a virus enters the body, it quickly replicates (‘makes copies of itself’) inside cells in the nose and lung, causing a viral infection. We expect Neumifil™ will work by binding to a substance (called glycans, which are made up of sugars) on the surface of cells in the nose, that the virus uses to attach to the cells, so that the virus can’t enter cells and cause an infection.
This is a 2-part study (Parts A and B) in healthy volunteers, aged 18–60. We aim to find out the side effects and blood levels of single and repeated doses of Neumifil™ when given as a nasal spray. Neumifil™ has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses.
In Part A, we’ll test single doses of Neumifil™ or placebo, in up to 5 groups, (up to 36 volunteer participants in total). Participants will take up to 2 weeks to complete the study. They will stay on the ward for 2 nights in a row and make 1 outpatient visit.
In Part B, we’ll test repeated doses of study medicine or placebo, in up to 3 groups, (24 volunteer participants in total). Participants will receive the study medicine, once-daily for up to 7 days. Participants will take up to 3 weeks to complete the study. They will stay on the ward for 8 nights in a row and make 2 outpatient visits.
A pharmaceutical company (Pneumagen) is funding the study.
The study will take place at 1 centre in London.
Summary of Results
Researchers look at the results of many studies to understand if experimental new medicines work and how they work. It takes lots of people in many studies all around the world to advance medical science. This summary shows the results from only this study. Other studies may find different results. We are extremely grateful to the study participants who took part in this important research.
Why did we do the study?
The study medicine (Neumifil) is an experimental new medicine for preventing infections with certain types of viruses, including COVID-19 virus and influenza (‘flu’) virus. Most people who get infected with COVID-19 or flu have only a mild illness and recover without medical treatment. But some people, particularly the elderly or those with existing health problems, can become seriously ill. We hope the study medicine will be an improvement on existing treatments and cause fewer side effects.
We tested single and repeated doses of the study medicine in healthy volunteers. The study medicine had never been given to humans before, so we started with a low dose and increased the dose as the study progressed. We aimed to find out its side effects of the medicine, when given as a nasal spray.
In this study, some people took placebo (a dummy medicine that had no active ingredient) instead of the study medicine – a computer decided who took which. The study medicine and placebo looked the same, so neither the study doctor nor the participants knew which one they were taking. That was done to make sure the study results weren’t influenced in any way.
Who organised the study and when did it take place?
The doctors and support staff of HMR, London, UK organised the study. A pharmaceutical company – Pneumagen, Fife, Scotland (the ‘sponsor’) – paid for the study.
The study took place at HMR (London) from 07 Oct 2021 until 05 Apr 2022. We completed the study as planned.
Who took part in the study and what treatments did they take?
This was a 2-part study. We tested single doses of the study medicine in Part A, and repeated doses in Part B. In total, 60 healthy volunteers, aged 18–60 years, took part; 36 in Part A and 24 in Part B.
Participants took the study medicine or a dummy medicine (placebo) as a nasal spray.
What were the results of the study?
Side effects
Side effects are unwanted medical events (such as headache) that happen during the study and are reported because the study doctor believes the side effects may have been related to the study medicine. In this study, we found out the following.
• There were no serious side effects – those are side effect that are life threatening or required someone to go to hospital.
• Not all people in the study had side effects.
• The most common side effects (reported by more than 1 out of 60 people) were short-lived and included: nose irritation, bad taste in the mouth, sneezing, change in smell or taste, runny nose, and nose feeling dry.
• More side effects were seen at higher doses.
• People had fewer side effects after taking the study medicine for a few days.Other results
• The study medicine was safe and well tolerated at the doses tested.How has the study helped patients and researchers?
The results of this study have been used to decide the doses in other studies to learn whether people are helped by the study medicine.
Are there plans for further studies?
Studies of Neumifil (the study medicine) are ongoing and further trials are planned, to find out if the study medicine prevents virus infection.
Where can I find more information about the study?
You can find out more detailed information about this study at ClinicalTrials.gov and https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.pneumagen.com%2Fneumifil&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca09df2e5fd9042f21efb08db35eb3ed4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638163056704990009%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=urD6uY62zvX5YeZfcf2%2BK%2BrquKlPbqjmcYV9n8L4yi0%3D&reserved=0.
If you would like more general information about clinical trials, the UK Clinical Research Collaboration (UKCRC) booklet ‘Understanding Clinical Trials’ has information about medical research, and questions you might want to ask. If you’d like to read it, please visit https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.ukcrc.org%2Fwp-content%2Fuploads%2F2014%2F03%2FiCT_Booklet.pdf&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ca09df2e5fd9042f21efb08db35eb3ed4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638163056704990009%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=jcijvOCM%2BlJrCZQCZhy%2BaOISMd82NClMwK%2BXjtQSTiU%3D&reserved=0
REC name
London - Chelsea Research Ethics Committee
REC reference
21/HRA/1566
Date of REC Opinion
5 Oct 2021
REC opinion
Further Information Favourable Opinion