We are looking for healthy male and female volunteers to participate in a study to show if the trial drug FF-3 has a useful effect in healthy adult subjects who have been experimentally infected with an attenuated influenza A virus.
FF-3 is inhaled through the nose. In previous human studies no significant side effects have been identified.
Participants must meet the following criteria:
Healthy male and female volunteers aged 18 – 50
You should have a body-mass Index (BMI) of 18-32 and weigh between 50-110KG inclusive (you can calculate your BMI in the pre-screening form)
You must be in good health and not suffer from any medical conditions
You cannot be a vegan or have any medical dietary restrictions
You also cannot care for or cohabit with any of the following
the elderly (65+)
children aged 5 or under
persons diagnosed with cancer, emphysema, chronic obstructive pulmonary disease, severe lung disease or have had any transplants
There are other reasons why you may or may not qualify for this study. You can find out now if you are eligible to be screened by completing the short pre-screening form.
The drug being tested in this study is Fluvirvitide-3 (FF-3), this is a drug that has the potential to help prevent and treat the Flu.
Study payment is £2520
Inpatient visit: Tuesday 1st December – Saturday 12th December
Follow up: Monday 4th January.
Screening for group 3 will take place between the 10th and 30th October.
Register for group 3
Volunteers are required to attend the unit 4 times.
There will also be groups following these dates.
Potential subjects will first undergo initial “panel screening” to demonstrate good health and if you have been previously infected by a specific flu strain. Panel screening will take place no greater than 3 months prior to the study screening visit. You will only be invited for the extensive study screening if your results from the panel screen are suitable
Visit 1 Screening If your results from the Panel Screening visit show that you are in good health, and have not been exposed to the specific flu strain used in the study, you will be invited to a further screening visit for the study. This will involve a doctor going through your medical history and a physical examination. You will have a number of tests during screening including blood pressure, heart rate, 12 Lead ECG (non-painful tracing of your heart), spirometry (breathing tests), measurement of your height and weight, blood and urine tests. This appointment determines your eligibility to take part in the trial.
Visit 2 – Admission
You will be admitted to the unit 2 days before dosing. This will be a single admission of 12 days and 11 nights. Upon arrival eligibility will be re- checked through repeat tests to ensure there are no changes to your health. You will be placed in “quarantine” and you will not be allowed to leave the ward for the stay.
On the day of dosing you will be administered FF-3 or placebo (dummy drug) intra nasally (through the nose). Approximately 4 hours later you will receive the flu virus intra nasally. You will then be administered the study drug or placebo twice a day for the following 5 days. Throughout the duration of your visit at set time points you will have a number of assessments including; measurement of your vital signs, nasal washes, 12 lead ECGs and blood tests, urine tests, and a physical examination.
Visit 3 Follow up appointment
This will take place up to 20 days following your discharge from the unit.
Before every clinical trial, each medicine has undergone extensive laboratory testing, and every trial has to be approved by the MHRA (Medicine and Healthcare products Regulatory Agency) and an Independent Research Ethics Committee, who will evaluate and ensure the wellbeing of the volunteers is safeguarded.
The trials are such a valuable part of the process as they are stringently designed to guarantee the quality, reliability, and safety of new medicines.
In the last seven years, Quintiles Drug Research Unit at Guy’s Hospital has conducted over 1000 Phase 1 development studies worldwide. This has seen thousands of paid volunteers taking part in the trials, each making a hugely valuable contribution to medical research.
Quintiles Drug Research Unit at Guy’s Hospital is based in London and has over twenty years of Phase 1 clinical research experience in this unit, and this site alone has been involved in the testing of more than 200 potential new medicines.
If you would like to register to take part in a clinical trial at Quintiles Drug Research Unit at Guy’s Hospital.
By registering you are not making a commitment but simply expressing an interest to find out more. We will ask you a few more details about your health and will then discuss what studies you may be suitable for.
Studies will be approved by a recognized independent Research Ethics Committee