A study to investigate the safety, tolerability, and pharmacokinetics of mAb in patients with IPF

• Research type

  Research Study

• Full title

  A Phase Ib, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of an intravenous monoclonal antibody (mAb) after single ascending doses in subjects affected by idiopathic pulmonary fibrosis.

• IRAS ID

  1005931

• Contact name

  Laura Bonino

• Contact email

  l.bonino@chiesi.com

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2022-001079-15

• Clinicaltrials.gov Identifier

  NCT05513950

• Research summary

  The purpose of this study is to assess the safety of CHF10067 (the study drug) and any side effects that might be associated with it. In addition, the study will evaluate how much of the study drug gets into the bloodstream and how long the body takes to remove it. The body’s immune response to the study drug will also be evaluated. The study may also evaluate the effect of the study drug on the level of a certain protein in the body.
  We are conducting this study on people affected by idiopathic pulmonary fibrosis (IPF; a lung disease).
  The reason we are doing this study is to establish the doses suitable for future studies in subjects

• REC name

  London - Brent Research Ethics Committee

• REC reference

  22/LO/0516

• Date of REC Opinion

  13 Oct 2022

• REC opinion

  Further Information Favourable Opinion