Comparison of blood levels and safety of CHF6001 in healthy Caucasian and Japanese participants
Research type
Research Study
Full title
A single-centre, randomised, double-blind, placebo-controlled, two-period, one-sequence, parallel-group (Caucasian and Japanese) ethnic sensitivity study to assess the pharmacokinetics, safety, and tolerability of two dose levels of CHF6001 Dry Powder Inhaler (DPI) administered as single and multiple doses in healthy participants
IRAS ID
1012640
Contact name
Emilie Oosterom
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A
Clinicaltrials.gov Identifier
TBC
Research summary
The study medicine (CHF6001) is an experimental treatment for chronic obstructive pulmonary disease (COPD) and asthma. These conditions involve long-term inflammation (swelling and irritation) of the airways, with symptoms such as breathlessness, coughing and wheezing. Over time this can make it harder to breathe and may cause permanent damage to the lungs.
We hope that the study medicine will work by blocking an enzyme (a substance that causes biological changes in the body) called phosphodiesterase-4 (PDE4), to reduce inflammation. Other medicines that block PDE4 can cause side effects such as diarrhoea, nausea, decreased appetite and weight loss, which can lead to patients stopping treatment. The study medicine has been designed to be inhaled directly into the lungs without circulating the rest of the body, which should cause fewer side effects than the existing similar medicines.
If this and future studies are successful, the study medicine would be a useful treatment for patients in many countries, including Japan. But first, we need to test the drug in healthy Japanese people, so that we can compare the results with those from other ethnic groups.
We’ll give 15 healthy Japanese participants and 15 healthy Caucasian participants (aged 18-55) a single dose of the study medicine or placebo, followed by 14 daily doses of the study medicine/placebo, in 2 treatment periods. In the first treatment period they will receive the dose we expect to treat patients with, in the second they will receive a higher dose. We aim to find out its side effects and compare blood levels of the study medicine in Caucasian and Japanese participants.
Participants will take up to 9 weeks to finish the study. They’ll stay on the ward for 20 days in a row in each session, and have 1 outpatient visit.
A pharmaceutical company (Chiesi) is funding the study.
The study will take place at 1 centre in London.REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0218
Date of REC Opinion
1 Sep 2025
REC opinion
Further Information Favourable Opinion