Phase 2a Study of SV001 for Safety and Immune Response in Adults with Idiopathic Pulmonary Fibrosis

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and immune response of a drug called SV001 in patients with idiopathic pulmonary fibrosis IPF, a lung condition. This Phase IIa clinical trial is randomized, double-blind, and placebo-controlled, aiming to gather detailed information about how the drug behaves in the body and its safety profile. Participants will receive multiple doses of SV001 or a placebo, with the study designed to compare these groups. The treatment period includes escalating doses to assess how the drug is tolerated and processed by the body. The study will last approximately one year, during which participants will be closely monitored. During the trial, participants will undergo regular assessments including checking for treatment-related adverse events, measuring the drug concentration in blood over time, and testing for immune responses. The main outcome is the incidence of adverse events over about one year. Additional evaluations will look at peak drug levels, time to peak levels, drug exposure over time, half-life, and immunogenicity. Safety and tolerability will be continuously monitored throughout the study period.

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis