drugset / Trial / NCT02598999

Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients

NCT02598999 ↗

Phase 1 Terminated 92 enrolled Alaxia SAS
RandomizedParallel-groupDouble-blindTreatment

Summary

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 (CF) and non-CF bronchiectasis (NCFBE).

Timeline

Start
2015-11
Primary completion
2021-12
Completion
2021-12

Outcome

Outcome not reported

Stopped (Business): “Financial issues”

Drugs

EvaluationDrugModalityDoseRoute
Subject ALX-009 Unknown — Inhaled
Subject OSCN- Unknown — Inhaled
Subject bLF Unknown — Inhaled