Safety and Tolerability of AZD9898 in Healthy Volunteers & Asthmatics

• Research type

  Research Study

• Full title

  A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Oral Doses of AZD9898 in Healthy Volunteers and Asthma Patients

• IRAS ID

  225083

• Contact name

  Muna Albayaty

• Contact email

  muna.albayaty@parexel.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2016-004237-24

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  This is a phase 1, randomized, placebo-controlled clinical study being conducted to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD9898. The study consists of 3 parts:

  Part 1: Single ascending doses in healthy volunteers
  Part 2: Single ascending doses in asthma patients
  Part 3: Multiple ascending doses in healthy volunteers (including a food effect group)

  This will be the first time AZD9898 is given to human participants and is a First in Human (FiH) clinical trial. AZD9898 is being developed by AstraZeneca AB for the treatment of Asthma. Asthma is a common lung condition characterized by inflammation of the airways in the lung and causes occasional breathing difficulties. The main symptoms are wheezing (whistling sound when breathing), shortness of breath, a tight chest and coughing.

  The main purpose of this study is to see how safe AZD9898 is after single doses in healthy volunteers and asthma patients, and after multiple doses in healthy volunteers. The study will also investigate the pharmacokinetics of AZD9898 in the body and the effect of AZD9898 on urine leukotriene E4 (a molecule produced by white blood cells). Additionally, the study will involve the collection of:

  - an optional genetic blood sample
  - blood samples for exploratory safety, PD and efficacy biomarkers
  - blood and urine for the analysis of the metabolites of AZD9898

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  17/EE/0121

• Date of REC Opinion

  2 May 2017

• REC opinion

  Further Information Favourable Opinion