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

This study is currently recruiting participants.
Verified December 2012 by GangaGen, Inc.
Sponsor:
Information provided by (Responsible Party):
GangaGen, Inc.
ClinicalTrials.gov Identifier:
NCT01746654
First received: December 5, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Infectious Disease
Bacterial Infections
 Drug: P128-0.1 mg
Drug: P128-0.3 mg
Drug: P128-1.0 mg
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Double-Blind Placebo-Controlled Study to Determine Safety of P128 Applied to Nares of Healthy Volunteers and Safety And Efficacy of P128 Applied to Nares of Chronic Kidney Disease Patients Who Are Nasal Carriers of S.Aureus.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GangaGen, Inc.:

Primary Outcome Measures:
  • Safety and tolerability (Part A, Part B and Part C) [ Time Frame: 30 Days (Part A and Part B), 20 Days (Part C) ] [ Designated as safety issue: Yes ]
    The number of adverse events, type of adverse events, frequency of adverse events and proportion of subjects with adverse events and the severity, seriousness and the relationship of adverse event to the treatment

  • Efficacy (Part C) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Rate of S. aureus clearance following 5 days of treatment with various doses of P128


Secondary Outcome Measures:
  • Immunogenicity (Part A, Part B and Part C) [ Time Frame: 8 Days (Part A), 13 Days (Part B) ] [ Designated as safety issue: No ]
    Levels of antibodies to the investigational product in serum before and after administration of the drug will be compared to understand immunogenicity of the drug.

  • Pharmacokinetics (Part A and Part B) [ Time Frame: 1 Day (Part A), 6 days (Part B) ] [ Designated as safety issue: No ]

    AUC0-t, AUC0-∞, Cmax, Tmax, Tlag, Kel and AUC_% will be measured; AUC means area under curve

    Part A Baseline Pre-dose: before 1st dose on Day 1. Post - dose: 5 min, 15 min, 30 min, 1hr, 2hrs and 6hrs after first dose(on day 1)

    Part B Baseline Pre-dose: before 1st dose on Day 1. Post - dose: 5 min, 15 min, 30 min, 1hr, 2hrs and 6hrs after first dose(on day 1) Pre-final dose Post - dose: 5 min, 15 min, 30 min, 1 hr, and 12 hours post last dose - after the last dose is administered.


  • Secondary efficacy (Part C) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Rate of S. aureus clearance following 3 days of treatment with various doses of P128

  • Re-colonization (Part C) [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    Rate of re-colonization by S. aureus 7 and 14 days after the last day of treatment with various doses of P128


Estimated Enrollment: 64
Study Start Date: December 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: P128-0.1 mg
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)
 Drug: P128-0.1 mg
P-128 at 0.1 mg divided evenly between the nares is administered once in Part A and multiple times in Part B and Part C
Other Names:
  • Single dose in Part A
  • Multiple doses in Part B
  • Multiple doses in Part C
Experimental: P128-0.3 mg
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)
 Drug: P128-0.3 mg
P-128 at 0.3 mg divided evenly between the nares is administered once in Part A and multiple times in Part B and Part C.
Other Names:
  • Single dose in Part A
  • Multiple doses in Part B
  • Multiple doses in Part C
Experimental: P128-1.0 mg
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)
 Drug: P128-1.0 mg
P-128 at 1.0 mg divided evenly between the nares is administered once in Part A and multiple times in Part B and Part C
Other Names:
  • Single dose in Part A
  • Multiple doses in Part B
  • Multiple doses in Part C
Placebo Comparator: Placebo
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)

Detailed 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 three 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy human volunteer
  • Chronic Kidney disease patients stable on dialysis who are nasal carrier of S. aureus or MRSA.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746654

Contacts
Contact: Dale A Fisher, MBBS,FRACP dale_andrew_fisher@nuhs.edu.sg
Contact: Liong HC Linda, M.Pharma linda.liong@ecronacunova.com

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Dale A Fisher, MBBS, FRACP         dale_andrew_fisher@nuhs.edu.sg    
Principal Investigator: Dale A Fisher, MBBS, FRACP            
National University Hospital Recruiting
Singapore, Singapore
Principal Investigator: Dale A Fisher, MD            
Sponsors and Collaborators
GangaGen, Inc.
Investigators
Principal Investigator: Dale A Fisher, MBBS, FRACP National University Hospital, Singapore
Study Director: Surinder Kher, MD Manipal Acunova Ltd, Bangalore
  More Information

No publications provided

Responsible Party: GangaGen, Inc.
ClinicalTrials.gov Identifier: NCT01746654     History of Changes
Other Study ID Numbers: P128-001
Study First Received: December 5, 2012
Last Updated: December 13, 2012
Health Authority: Singapore: Health Sciences Authority

Keywords provided by GangaGen, Inc.:
S.aureus
Methicillin Resistant S.aureus (MRSA)
Nasal carrier status
Prophylaxis

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Infection
Renal Insufficiency, Chronic
 Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013