HV Study to Compare Two PrEP-001 Nasal Powder Formulations (QCL117975)
Research type
Research Study
Full title
A Single Centre, Partially Blinded, Randomised Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production in Healthy Human Volunteers
IRAS ID
224933
Contact name
Tim Jenkins
Contact email
Sponsor organisation
PrEP Biopharm
Eudract number
2017-001030-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 17 days
Research summary
The Sponsor is developing PrEP-001 nasal powder for the prevention of viral upper respiratory tract infection such as the common cold. PrEP-001 works to stimulate the body's natural defensive response to the viruses that cause these infections.
The nasal powders are sprayed into each nostril via a single use disposable device. The products to be tested are Formulation A and Formulation B. It is hoped that Formulation B will decrease the number of sprays someone would have to take per administration of the drug.The study will compare the effect and safety of the two different formulations (A and B) on the activity of the immune system over five days of consecutive dosing by taking samples of blood and from inside the nose. The study will also investigate whether there is a difference between the Formulation B and placebo.
20 subjects will be enrolled and will be randomly allocated to receive 1 of 4 treatments. This will be either, 6.4 mg PrEP-001 Formulation A, 6.4 mg PrEP-001 Formulation B, 3.2 mg PrEP-001 Formulation B or the placebo. The study is partially blinded. The subjects will only know that they will receive one of the four treatments, but not know the specific one they receive. The study sponsor and study staff, other than the dosing team, will also not be aware of the treatment allocation.
Subjects will receive their allocated treatment for five consecutive days whilst remaining resident in the clinical unit. They will leave the clinical unit 3 days after their final dose. During the clinical residency, blood samples and fluid samples of the inside of the nose (using a tool like a cotton bud) will be taken on a regular basis. Safety assessments will also be performed regularly. Subjects will return for a follow-up visit 14 days after their last dose.
REC name
Wales REC 1
REC reference
17/WA/0082
Date of REC Opinion
12 Apr 2017
REC opinion
Further Information Favourable Opinion