Last updated on February 2018

First-in-man Dose Escalation Study of ALX-009 and Its Components in Healthy Men and Cystic Fibrosis Suffering Patients


Brief description of study

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis.

Detailed Study Description

Part I: SAD of OSCN- and bLF in healthy male volunteers (cohorts 1 to 3) - Part II: SAD and MAD of ALX-009 in healthy male volunteers (cohorts 4 and 5) - Part III: MAD of OSCN- and bLF in patients suffering from cystic fibrosis (cohorts 6 to 8) - Part IV: MAD of ALX-009 in patients suffering from cystic fibrosis (cohorts 9 to 11)

Clinical Study Identifier: NCT02598999

Contact Investigators or Research Sites near you

Start Over

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.