A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Phase 1 Completed 21 enrolled Hoffmann-La Roche

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.

Timeline

Start: 2011-03-29
Primary completion: 2012-07-02
Completion: 2012-07-02

Publications

van den Blink B, Dillingh MR, Ginns LC, Morrison LD, Moerland M, Wijsenbeek M, Trehu EG, Bartholmai BJ, Burggraaf J. Recombinant human pentraxin-2 therapy in patients with idiopathic pulmonary fibrosis: safety, pharmacokinetics and exploratory efficacy. Eur Respir J. 2016 Mar;47(3):889-97. doi: 10.1183/13993003.00850-2015. Epub 2016 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zinpentraxin Alfa	Protein / enzyme biologic	1 mg/kg	Intravenous
Subject	Zinpentraxin Alfa	Protein / enzyme biologic	5 mg/kg	Intravenous
Subject	Zinpentraxin Alfa	Protein / enzyme biologic	10 mg/kg	Intravenous

A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Summary

Timeline

Publications

Drugs

Indications