At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating CHF10067 starting dose -- 1000mg (Cohort A), CHF10067 intermediate dose -- 2000mg (Cohort B), and 2 other interventions for Idiopathic Pulmonary Fibrosis. Completed, enrolled 52 participants across 9 sites in 3 countries.
Detailed Summary
Assess the safety of CHF10067 (study drug) and any side effects that might be associated with it. The study also evaluated 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 was evaluated. Chiesi conducted this study in patients affected by idiopathic pulmonary fibrosis (IPF, a progressive and chronic lung disease). Chiesi performed this study to establish the drug doses that would be suitable for future studies (a dose finding study).
Study Details
Timeline
Interventions
Intravenous administration of a starting dose of the monoclonal antibody
Intravenous administration of an intermediate dose of the monoclonal antibody
Intravenous administration of a high dose of the monoclonal antibody
Intravenous administration of a physiological solution as placebo