PB01 in an inhaled LPS challenge study in healthy subjects
Research type
Research Study
Full title
A Phase I, double-blind, placebo-controlled, randomised, crossover study to assess the anti-inflammatory effects of orally inhaled PB01 following an inhaled lipopolysaccharide (LPS) challenge in healthy male volunteers.
IRAS ID
190877
Contact name
Nuket Desem
Contact email
Sponsor organisation
Paranta Biosciences Limited
Eudract number
2015-004599-31
Clinicaltrials.gov Identifier
ANZCTR, ACTRN12616000496415 ; ,
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
The study drug (PB01) is a potential new inhaled drug that is being developed for the treatment of lung diseases such as as cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD).
The main purpose of the study is to examine how PB01 affects the immune/inflammatory response of the body to a Lipopolysaccharide (LPS) challenge. When LPS is inhaled by a healthy person it produces a short-lived response that is similar to that seen in people with certain lung diseases. The LPS challenge is a standard assessment used in respiratory research. This study will also assess the safety and tolerability of PB01, as well as measuring the amount of PB01 found in sputum (phlegm). Changes in the levels of biomarkers in both the volunteer's blood and sputum will be evaluated.
This study is a phase I, double-blind, placebo-controlled, randomised, crossover study. The aim is for 24 volunteers to be recruited with at least 15 completing both separate treatment periods. One 30mg dose of PB01 will be administered in one treatment period and one dose of placebo in the other treatment period, this will be via nebulisation at the clinical site on Day 1 of each treatment period. The LPS challenge will be performed 1 hour after dosing, followed by sputum induction 6 hours after the LPS challenge.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0858
Date of REC Opinion
19 Feb 2016
REC opinion
Further Information Favourable Opinion