Comparative Pharmacokinetics and Safety Assessment of 1st‐ and 2nd‐Generation Zinpentraxin Alfa Drug Products in Healthy Volunteers: A Randomized Crossover Study

Abstract

AbstractZinpentraxin alfa is a recombinant form of the human pentraxin‐2 that was studied in idiopathic pulmonary fibrosis (IPF). To improve the purity and yield of the drug material, a 2nd‐generation drug product was developed. To characterize and compare the pharmacokinetic (PK) properties of the 1st‐ and 2nd‐generation zinpentraxin alfa, PK studies were conducted in healthy volunteers (HVs). In a phase 1 randomized, double‐blind, 2‐sequence crossover, sequential 2‐stage study (ISRCTN59409907), single intravenous (IV) doses of 1st‐ and 2nd‐generation zinpentraxin alfa at 10 mg/kg were studied with a blinded interim analysis (IA) at the end of stage 1. Bioequivalence (BE) was achieved for the maximum observed plasma concentration (Cmax), but the overall exposure was higher for the 2nd‐ compared to the 1st‐generation zinpentraxin alfa. The study was stopped after stage 1 as the gating criteria were met based on the result of the blinded IA. Safety profiles were similar for the 1st‐ and 2nd‐generation drug products, and antidrug antibody (ADA) was not observed in this study.