A Clinical Trial in Healthy Volunteers to Investigate a New Medicine (AZD4604) for the Treatment of Asthma
Status:
Recruiting
Trial end date:
2022-09-26
Target enrollment:
Participant gender:
Summary
This first in human clinical study will assess the safety and tolerability, as well as the
single dose pharmacokinetics (PK), of inhaled AZD4604 in healthy volunteers (Part 1a, single
ascending dose [SAD]). The single dose administration will be performed with dry powder
inhaler (DPI) formulation of AZD4604. When at least 4 cohorts of the SAD part of the study
have been completed, AZD4604 will be administered as a single intravenous (IV) or oral (PO)
dose to 2 different cohorts of healthy volunteers (Part 1b). The main purpose is to compare
the PK between IV and inhaled administration as well as between oral and inhaled
administration to further characterize the PK properties of AZD4604 by the various
administration routes. The results will be used to improve future study design and
interpretation.