Safety, Tolerability and PK of AZD8871 in Healthy Japanese Subjects
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 Japanese Subjects
IRAS ID
225405
Contact name
Muna Albayaty
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-000890-35
Duration of Study in the UK
0 years, 4 months, 6 days
Research summary
This is a phase 1, randomised, single-blind, placebo-controlled multiple ascending dose clinical study in healthy male Japanese 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.
This will not be the first time AZD8871 has been given to human participants. A multiple ascending dose (MAD) study has recently completed clinically in healthy male Caucasian participants. The MAD doses (up to 900µg) raised no safety or tolerability concerns.
AZD8871 is a new drug being developed by AstraZeneca AB. AstraZeneca are developing the drug for treating chronic obstructive pulmonary disorder (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 saliva and mucus production.
Asthma 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.
The main purpose of the study is to see how safe the drug is and how well the body tolerates the drug after multiple doses are administered to healthy male Japanese participants. The study will also 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.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0127
Date of REC Opinion
20 Apr 2017
REC opinion
Favourable Opinion