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

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Recruitment Status: Open

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