A Phase 1 trial to study inhaled RV6153 (QCL117440)
Research type
Research Study
Full title
A randomized, double blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of treatment with single and repeat doses of inhaled RV6153 in healthy subjects and subjects with stable asthma.
IRAS ID
180762
Contact name
Paul Russell
Contact email
Sponsor organisation
Respivert Ltd
Eudract number
2015-000440-41
Duration of Study in the UK
0 years, 9 months, 24 days
Research summary
The Sponsor is developing the study drug, RV6153, for the potential treatment of uncontrolled asthma and chronic obstructive pulmonary disease (COPD). This study has been designed to look at the safety of RV6153, how the body tolerates the drug, and how the drug is taken up in the body when given at different doses.
The study will consist of 4 parts involving up to 119 male and female subjects in total. Part A will comprise of an initial series of 9 parallel groups (cohorts) each containing 8 subjects. Subjects will receive a single inhaled dose of study drug or placebo (dummy drug) with a low dose level for the first cohort, rising to a higher dose level in each additional cohort.
Part B will consist of up to 2 cohorts, each containing up to 9 healthy subjects. Subjects will receive a fixed dose of either RV6153 or placebo, repeated once daily for either 14 days (cohort 10) and 28 days (cohort 11).
Part C will consist of a single cohort of up to 9 subjects with controlled, stable asthma. Subjects will receive a fixed dose of either RV6153 or placebo once daily for 14 days.
Part D will consist of a single cohort of up to 20 healthy subjects who are current smokers. Subjects will receive a fixed dose of RV6153 or placebo once daily for 14 days.
REC name
Wales REC 1
REC reference
15/WA/0143
Date of REC Opinion
7 May 2015
REC opinion
Unfavourable Opinion