In the next coming months, IRCCS ISMETT in Palermo will launch a Phase I clinical trial to evaluate the safety and tolerability of a new drug therapy for the treatment of pulmonary fibrosis.
The study will be the first Phase I clinical trial conducted in Sicily and will be carried out by ISMETT’s Phase I Clinical Trials Unit, a facility dedicated to the early stages of clinical development of new medicines.
“The study highlights the value of the research infrastructure ISMETT has built by investing in expertise, organization, and safety,” said Angelo Luca, Director of ISMETT. “Our Phase I Clinical Trials Unit enables us to develop new therapies from their earliest stages. This is important not only for ISMETT, but for the entire regional health system. It strengthens Sicily’s role in national clinical research and creates new opportunities for patients with complex diseases for which satisfactory therapeutic options are still lacking.”
Phase I represents the first stage of clinical testing in humans following preclinical studies. At this stage, the main objective is to evaluate the safety of treatment, monitor adverse events, and collect information on how the drug behaves in the human body. The ability to conduct Phase I clinical trials is reserved for highly qualified centers capable of ensuring dedicated personnel, specialized expertise, rigorous procedures, quality systems, and a capacity to respond immediately in the event of adverse reactions.
The study that will be launched at ISMETT concerns a new drug therapy for pulmonary fibrosis, a chronic disease characterized by the progressive formation of scar tissue in the lungs and the resulting decline in respiratory function.
“This study will allow us to carefully evaluate the safety and tolerability of a new treatment for patients with pulmonary fibrosis,” said Patrizio Vitulo, Medical Director of the Phase I Clinical Trials Unit and Head of ISMETT’s Pulmonology Unit. “This is the first step in a complex but essential research pathway to determine whether a new therapy can become a treatment option in the future. Every piece of data will be important to guide the subsequent stages of clinical development, in full compliance with the highest standards of safety and participant protection.”
In Italy, authorization to conduct Phase I clinical trials is regulated by the Italian Medicines Agency (AIFA), which verifies centers meet specific organizational, professional, infrastructural, and quality requirements. Most qualified centers are currently located in central and northern Italy. The presence of an active Phase I Clinical Trials Unit in Sicily is a strategic milestone for clinical research on the island. This study strengthens ISMETT’s role within Italy’s national clinical research network and confirms its commitment to developing innovative therapies through a model that integrates specialized patient care, scientific research, and patient safety.
