drugset / Trial / NCT05513950

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

NCT05513950 ↗

Phase 1 Completed 52 enrolled Chiesi Farmaceutici S.p.A.
RandomizedSequentialQuadruple-blindTreatment

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).

Timeline

Start
2023-01-25
Primary completion
2024-06-17
Completion
2024-06-17

Drugs

EvaluationDrugModalityDoseRoute
Subject CHF10067 Unknown 1000 mg Intravenous
Subject CHF10067 Unknown 2000 mg Intravenous
Subject CHF10067 Unknown 3000 mg Intravenous