Investigate Safety, Tolerability & Pharmacokinetics of Inhaled AZD0449
Research type
Research Study
Full title
A Single blind, Randomized, Placebo-controlled Three part Study in Healthy Volunteers and Patients with Mild Asthma to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled AZD0449 Following Single and Multiple Ascending Doses and to Investigate the Anti-inflammatory Effect of Inhaled AZD0449
IRAS ID
250847
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2018-003469-32
Duration of Study in the UK
1 years, 1 months, 18 days
Research summary
Summary of Research
This is a single-blind, randomised, placebo-controlled, three-part study to investigate the safety, tolerability, pharmacokinetics (PK) and the anti-inflammatory effect of AZD0449 in healthy volunteers (Part 1) and patients with mild asthma (Parts 2 and 3). AZD0449 is a potentially new asthma drug that will be administered in single doses (Part 1) and repeated doses (Parts 2 and 3), using either a nebulizer or dry powder inhaler (DPI). As part of the investigation, a single cohort of healthy volunteers who previously took inhaled study medication will also be subject to intravenous (IV) administration of study medication (Part 1b).The study drug is being developed by AstraZeneca, for treatment of patients with moderate to severe asthma. Researchers foresee that the study drug will decrease overall inflammation and reduce episodes of worsening of symptoms, with accompanying improvement of lung function.
Each study part will include a screening visit, a treatment period and a follow-up visit. Eligible participants will remain residential at the Clinical Unit for the full duration of the treatment period.
This is a first-in-human clinical trial. Conditional inclusion of women of non-childbearing potential is allowed in this study. The main purpose of the study is to see how safe the study drug is and how well the body tolerates the study drug after single and repeated doses, administered by inhalation. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as PK). In addition, the study will investigate the anti-inflammatory effect as a measure of the effects of the study drug on the body (referred to as pharmacodynamics [PD]) and the way in which the study drug works (mechanism of action).
Summary of Results
The lay summary of study results is under preparation and will be posted on https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.trialsummaries.com%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C26977fb0dd784dcbe09008da8f6aa522%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637979985463671250%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=h0%2FgklzwqrC4cd%2BqU6cSPOgdJKYruBu8DxulSsto2Bc%3D&reserved=0 within 2 years of study end.REC name
London - London Bridge Research Ethics Committee
REC reference
18/LO/1432
Date of REC Opinion
14 Nov 2018
REC opinion
Further Information Favourable Opinion