A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF

Study Identifier:
CLI-10067AA1-01
ClinicalTrials.gov Identifier:
NCT05513950
EudraCT Identifier:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Idiopatic Pulmonary Fibrosis
Study Drug
  • Biological: CHF10067 starting dose
  • Biological: CHF10067 intermediate dose
  • Biological: CHF10067 high dose
  • Drug: Placebo
Date
Jan 2023 - Jun 2024
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Healthy Volunteers
No

Protocol 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. Chiesi is conducting this study on patients affected by idiopathic pulmonary fibrosis (IPF, a lung disease). Chiesi is doing this study to establish the doses suitable for future studies.

Study Locations

Location
Status
Location
PHI University Clinic of Pulmonology and Allergology
Skopje, Unmapped, 1000
Status
N/A
Location
Medical Center of Limited Liability Company "Arensia Exploratory Medicine", department of Clinical Trials
Kyiv, Ukraine, 01135
Status
N/A
Location
Queen Elizabeth Hospital - NIHR Birmingham Clinical Research Facility - University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2TH
Status
N/A
Location
Royal Papworth Hospital NHSFT - Cambridge Biomedical Campus
Cambridge, United Kingdom, CB2 0AY
Status
N/A
Location
University of Dundee, NHS Tayside - Ninewells Hospital & Medical School
Dundee, United Kingdom, DD1 9SY
Status
N/A
Location
Interstitial Lung Disease Research - NHS Lothian - Royal Infirmary of Edinburgh,
Edinburgh, United Kingdom, EH16 4SA
Status
N/A