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

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.

Source: Clinical Pharmacology in Drug Development - April 23, 2024 Category: Drugs & Pharmacology Authors: Tu H. Mai, Rajbharan Yadav, Audrey Arjomandi, Christine Jung, Monika M. Meier, Francis Donaldson, Rui Zhao, Han ‐Ting Ding, Joy C. Hsu, Nikhil Kamath, Lin Pan Tags: Original Article Source Type: research