Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects
Status:
Completed
Trial end date:
2016-11-28
Target enrollment:
Participant gender:
Summary
AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which
presents a novel treatment approach to chronic obstructive pulmonary disease [COPD] and
potentially also asthma (in combination with an inhaled corticosteroid [ICS]). The
therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism
bronchodilators, with an equivalent or superior safety and tolerability profile. The primary
purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A
multiple ascending dose (MAD) design has been selected for this study following the first
time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an
ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses
will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the
previous dose. The aim of this study is to also enable further investigations in healthy
subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable
side-effect profile compared to other inhaled bronchodilators on the market as a treatment
for COPD and asthma.