At a glance
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A Phase I, Single Centre, Randomised, Single Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Inhaled AZD8871 in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating AZD8871 and Placebo for Chronic Obstructive Pulmonary Disease. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Multiple inhaled doses of AZD8871 will be administered via single dose dry powder inhaler (DPI). Each subject will receive a single inhaled dose of AZD8871 on Day 1 and then single once daily inhalations of AZD8871 will be administered for 12 days from Day 5 until Day 16.
Multiple inhaled doses of placebo powder will be administered via single dose DPI. Each subject will receive a single inhaled dose of placebo on Day 1 and then single once daily inhalations of placebo will be administered for 12 days from Day 5 until Day 16.