To Investigate the Safety, Tolerability, PK and PD of AZD8630

• Research type

  Research Study

• Full title

  Phase I, Randomised, Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8630 in Healthy Adult Subjects (Part A) and Adults with Asthma on Medium to High Dose Inhaled Corticosteroids and Long-acting Beta-agonists (Part B)

• IRAS ID

  303730

• Contact name

  Dinesh Saralaya

• Contact email

  dinesh.saralaya@bthft.nhs.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2021-004000-18

• Duration of Study in the UK

  0 years, 8 months, 27 days

• Research summary

  This study will be the first investigation of AZD8630 in humans and is primarily designed to investigate safety and tolerability of single and repeat inhaled doses. The study will also investigate how the study drug is taken up into the body, chemically broken down, distributed through the body, and removed from the body (pharmacokinetics).

  The study consists of 2 parts:
  • Part A: single dose and repeated daily doses over 14 days in HVs.
  Rising doses will be given to separate cohorts (groups) in a single-blind, randomised, placebo-controlled design. This part consists of 4 sub-parts (A1: 5 cohorts; A2: 2 cohorts; A3: 3 cohorts; A4: 2 cohorts [8 participants per cohort]). Up to 8 additional cohorts may be investigated if required and justified from safety and PK data. Part A includes a screening visit, treatment period and a follow-up visit. Participants will stay inhouse for at least 3 days after dosing.

  • Part B: repeated daily doses over 28 days in asthma patients.
  There will be 3 dose-levels given in a double-blind, randomised, placebo-controlled design. Part B includes a screening visit, treatment period and a follow-up visit. Assessments will be completed at the study site for up to 12 hours after the first dose. Patients will return to the study site on Days 2, 7, 14, 28, and 29 for assessments. Day 21 will be a remote visit.

  AZD8630 is being developed by AstraZeneca AB, for asthma (chronic inflammatory disorder of the airways) treatment.

  As this is the first study with AZD8630 in humans, no human safety data is available yet. Based on the nonclinical safety data, no clinically significant undesirable effects are expected.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  21/LO/0586

• Date of REC Opinion

  28 Oct 2021

• REC opinion

  Further Information Favourable Opinion