drugset / Trial / NCT01746654
Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to determine whether the antibacterial protein P128 is (i) safe and well tolerated in healthy volunteers and in chronic kidney diseases patients on dialysis, (ii) is it effective in reducing the nasal carriage of pathogen (Staphylococcus aureus) in humans.
Timeline
- Start
- 2012-12
- Primary completion
- 2015-10
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P128 | Protein / enzyme biologic | 0.1 mg | Intranasal |
| Subject | P128 | Protein / enzyme biologic | 0.3 mg | Intranasal |
| Subject | P128 | Protein / enzyme biologic | 1 mg | Intranasal |