To Investigate the Safety Tolerability and PK of AZD4604
Research type
Research Study
Full title
A Single-blind, Randomized, Placebo-controlled 3 Part Study in Healthy Volunteers and Patients with Mild Asthma to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled AZD4604 Following Single and Multiple Ascending Doses and to Investigate the Anti-inflammatory Effect of Inhaled AZD4604
IRAS ID
290632
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-005244-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 5 days
Research summary
This is a single-blind, randomised, placebo-controlled, two-part study to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4604 in male and female healthy volunteers (Part 1) and patients with mild asthma (Part 2). In addition, the anti-inflammatory effect of inhaled AZD4604 will be evaluated in the asthma patients. AZD4604 is a potentially new asthma drug that will be administered in single doses using a nebulizer (Part 1a) and repeated doses using a dry powder inhaler (DPI) (Part 2). One dose level may be repeated in healthy subjects with a DPI (DPI cohort). As part of the investigation, a single cohort of healthy volunteers who previously took inhaled study medication will also be subject to intravenous (IV) and oral (PO) administration of study medication (Part 1b). Each study part will include a screening visit, a treatment period and a final assessment (Parts 1a and 2) or follow-up visit (Part 1b). Eligible participants will remain residential at the Clinical Unit for the duration of the treatment period.
AZD4604 has not been studied in man previously. This is a first-in-human clinical trial to see how safe the study drug is and how well the body tolerates the study drug. Single doses at increasing dose levels will be administrated by inhalation in 7 healthy subject cohorts, and intravenously and orally in another 2 cohorts. Repeated doses at increasing dose levels will be administered by inhalation in 3 patient cohorts. 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).
The study drug is being developed by AstraZeneca, for treatment of patients with severe, uncontrolled asthma. Researchers foresee that the study drug will improve symptoms, reduce episodes of worsening of symptoms, improve lung function, and have positive effects on disease progression.
Lay summary of study results: The Lay Language Summary is still in development, per Sponsor SOP this is released 2 years after LSLV.
REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0001
Date of REC Opinion
8 Jan 2021
REC opinion
Favourable Opinion