drugset / Trial / NCT02598999
Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALX-009 | Unknown | — | Inhaled |
| Subject | OSCN- | Unknown | — | Inhaled |
| Subject | bLF | Unknown | — | Inhaled |