Safety, Tolerability, PK and PD of MAD of inhaled AZD8871
Research type
Research Study
Full title
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
IRAS ID
202456
Contact name
Muna Albayaty
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2016-000776-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 7 days
Research summary
This is a phase 1, randomised, single-blind, placebo-controlled multiple ascending dose clinical study in healthy male volunteers. The study is being conducted to assess the safety, tolerability and pharmacokinetics (PK) of AZD8871. The study drug will be given to volunteers by inhalation (breathed in), using an inhaler.\n\nThis will not be the first time AZD8871 has been given to human participants. A single ascending dose (SAD) study is currently ongoing in mild asthmatic patients and patients with chronic obstructive pulmonary disease (COPD). The SAD doses (up to 2100µg) given in mild asthmatic patients raised no safety or tolerability concerns; the COPD portion of the study is starting in April 2016.\n\nAZD8871 is a new drug being developed by AstraZeneca AB. AstraZeneca are developing the drug for treating COPD and potentially asthma. COPD is the name for a collection of lung diseases including chronic bronchitis and emphysema. Patients with COPD find breathing difficult due to narrowing of the airways. Clinical symptoms include progressive shortness of breath, cough and sputum (saliva and mucus) production.\n\nAsthma is a common disease usually characterised by inflammation of the airways in the lung which can limit airflow. It results in respiratory symptoms such as shortness of breath, wheezing, chest tightness and cough.\n\nThe main purpose of the study is to see how safe the drug is and how well the body tolerates the drug after multiple doses. The study will also investigate the PK of the drug. This will look at how the drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). A further aim is to look at any potential effects on lung function and pupil diameter.
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0456
Date of REC Opinion
6 May 2016
REC opinion
Favourable Opinion