An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Trial of Tozorakimab

• Research type

  Research Study

• Full title

  A Multiple Centre, Randomised, Open label, Parallel Group, Phase I Pharmacokinetic Comparability Study of Tozorakimab Administered using an Accessorised Prefilled Syringe (APFS) or an Autoinjector (AI) in Healthy Volunteers

• IRAS ID

  1011498

• Contact name

  Claudia Percivalle

• Contact email

  information.center@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2024-511840-22

• Research summary

  The trial is a multi-centre, randomised, open label, Phase I trial in up to 252 healthy males and females between the ages of 18-55 years, with a body weight of 55 to 100kg, and a body mass index of 19-30 kg/m2.

  The medicine to be tested in this trial is a compound called Tozorakimab being developed for the treatment of lung diseases, such as symptomatic chronic obstructive pulmonary disease (COPD), asthma, and severe viral lower respiratory tract disease.

  The main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated following a single subcutaneous (under skin) injection of the clinical trial medicine with either an accessorized prefilled syringe (APFS) or an autoinjector (AI) into one of 3 injection sites. The clinical trial will also investigate how the clinical trial medicine is taken up, metabolised (chemically broken down), distributed through the body and excreted (removed from the body).
  Randomisation will be stratified by weight group based on weight (55 to < 70 kg, 70 to < 85 kg, and 85 to 100 kg), and within each of the 3 weight groups, participants will be randomised to one of the 6 combinations of the 2 devices (AZ or APFS devices) and one of three injection sites (abdomen, thigh, or upper arm).
  The trial will comprise of:
  - Screening period of a maximum 28 days
  - In-house Treatment Period: one night overnight stay Day -1 to Day 1
  - x12 Out-clinic Visits on Day 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85
  - A Follow up Visit on Day 113 after the dose of clinical trial medication

  This a not a first-in-human trial, which means that this medicine has been given to humans in clinical trials before. The trial will take place at 4 study sites in 3 countries.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  25/LO/0084

• Date of REC Opinion

  8 Apr 2025

• REC opinion

  Further Information Favourable Opinion