Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GangaGen, Inc.

Criteria

Inclusion Criteria:

• Healthy human volunteer

• Any patient clinically stable who are nasal carrier of S. aureus or MRSA including Chronic Kidney disease patients stable on dialysis

Exclusion Criteria:

• Presence of active systemic bacterial infection of any nature not cured at least 4 weeks before enrollment.

• Systemic or intra-nasal anti-bacterial treatment during four week period before enrollment

• Pregnancy, breast feeding during the study duration

• Participation in any other intervention study during the past three months