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

GangaGen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Infectious Disease; Bacterial Infections

Treatments: Drug: P128-1.0 mg; Drug: P128-0.1 mg; Drug: P128-0.3 mg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01746654

P128-001

Details and patient eligibility

About

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.

Full description

Staphylococcus aureus with acquired multiple-drug resistance poses an increasing problem in both hospital and community settings. S. aureus is known to cause infections ranging in severity from skin infection to systemic bacteremia. As nasal colonization is the principal ecological niche for these bacteria and has been shown to be a significant risk factor in developing S. aureus infection, it is of importance to develop an efficient therapy that is able to clear this bacterium from human nostrils.

In-vivo studies have shown that P128 treatment is efficacious in reducing and decolonizing MRSA bacteria from rat nostrils.

Pre-clinical safety studies in animal models indicated no test drug related toxicity signs at the site of application or systemically.

The present clinical trial is conducted in four parts. Part A consists of safety and tolerability studies in 4 cohorts of 3 healthy subjects who are administered a single dose of three escalating concentrations of the drug and placebo intra-nasally. Part B consists of safety & tolerability as in part A but with multiple doses (3 doses/day for 5 days). Part C comprises of safety/tolerability as well as efficacy studies in chronic kidney disease patients stable on dialysis who are nasal carriers of S.aureus or MRSA on a treatment regimen as in Part B. Part D comprises of safety and efficacy studies in any patient who are nasal carriers of S.aureus or MRSA with single dose of 3 escalating concentrations of the drug and placebo intra-nasally.

Enrollment: 74 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 4 patient groups, including a placebo group

P128-0.1 mg

Experimental group

Description:

Three healthy adult volunteers will be enrolled to P128-0.1 mg single dose-cohort 1 (Part A) Three healthy adult volunteers will be enrolled to P128-0.1 mg multiple doses-Cohort 4 (Part B) Ten chronic kidney disease patients will be enrolled to P128-0.1 mg multiple doses (Part C) Ten patient harboring S.aureus nasally will be enrolled to P128-0.1 mg single dose (Part D)

Treatment:

Drug: P128-0.1 mg

P128-0.3 mg

Experimental group

Description:

Three healthy adult volunteers will be enrolled to P128-0.3 mg single dose-Cohort 2 (Part A) Three healthy adult volunteers will be enrolled to P128-0.3 mg multiple doses-Cohort 5 (Part B) Ten chronic kidney disease patients will be enrolled to P128-0.3 mg multiple doses (Part C) Ten patient harboring S.aureus nasally will be enrolled to P128-0.3 mg single dose (Part D)

Treatment:

Drug: P128-0.3 mg

P128-1.0 mg

Experimental group

Description:

Three healthy adult volunteers will be enrolled to P128-1.0 mg single dose-Cohort 3 (Part A) Three healthy adult volunteers will be enrolled to P128-1.0 mg multiple doses-Cohort 6 (Part B) Ten chronic kidney disease patients will be enrolled to P128 1.0 mg multiple doses (Part C) Ten patient harboring S.aureus nasally will be enrolled to P128-1.0 mg single dose (Part D)

Treatment:

Drug: P128-1.0 mg

Placebo

Placebo Comparator group

Description:

Three healthy adult volunteers will be enrolled to placebo single dose-Cohort 1-3 (Part A) Three healthy adult volunteers will be enrolled to placebo multiple doses-Cohort 4-6 (Part B) Ten chronic kidney disease patients will be enrolled to placebo multiple doses (Part C) Ten patient harboring S.aureus nasally will be enrolled to placebo single dose (Part D)

Treatment:

Drug: Placebo