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 Japanese Subjects
Abstract
AZD8871 is a new chemical entity possessing long-acting dual-pharmacology (muscarinic receptor antagonist and β2 adrenoceptor agonist \[MABA\]) in a single molecule. This type of agent presents a novel approach to the treatment of chronic obstructive pulmonary disease (COPD) and potentially asthma (in combination with an inhaled corticosteroid). AZD8871 is being developed for inhalation, formulated with alpha lactose monohydrate and delivered by dry powder inhaler (DPI) that allows delivery of a single dose of the study drug.
The primary objective is to investigate the safety and tolerability of AZD8871 at steady state in healthy male Japanese subjects.
Conditions: Chronic Obstructive Pulmonary Disease - COPD.
Primary outcome: Adverse events.; Concomitant medication.; Physical examination.; Vital signs.; Number of clinically relevant new findings or worsening of a pre-existing findings as assessed by Hematology.; Number of clinically relevant new findings or worsening of a pre-existing findings as assessed by Clinical chemistry.; ECG.; 2-lead real-time telemetry ECG.; Number of clinically relevant new findings or worsening of a pre-existing findings as assessed by urinalysis report..
Enrollment: 25 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 25 participants or records.
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