drugset / Trial / NCT05513950
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibody (mAb) in Patients With IPF (SAD).
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CHF10067 | Unknown | 1000 mg | Intravenous |
| Subject | CHF10067 | Unknown | 2000 mg | Intravenous |
| Subject | CHF10067 | Unknown | 3000 mg | Intravenous |