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Completed

NCT Number: NCT01746654

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

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.

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Key information

Conditions

Infectious Disease Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National University Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P128-0.1 mg

Drug

P-128 at 0.1 mg divided evenly between the nares is administered once in Part A; multiple times in Part B and Part C; and once in Part D.

Other names: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

P128-0.3 mg

Drug

P-128 at 0.3 mg divided evenly between the nares is administered once in Part A; multiple times in Part B and Part C; and once in Part D.

Other names: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

P128-1.0 mg

Drug

P-128 at 1.0 mg divided evenly between the nares is administered once in Part A; multiple times in Part B and Part C; once in Part D.

Other names: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

Placebo

Drug

Placebo was administered to both nares once in part A, multiple times in Part B and Part C, Once in part D

Other names: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

Primary outcomes

  1. Safety and tolerability (Part A, Part B, Part C and Part D); Efficacy (Part C and Part D)

    Time frame: 30 Days (Part A and Part B), 20 Days (Part C), 7 Days (Part D)

    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. For efficacy, rate of S. aureus clearance following 5 days of treatment with various doses of P128 for Part C; rate of clearance following single dose treatment with various doses of P128 for Part D.

Secondary outcomes

  1. Immunogenicity (Part A, Part B and Part C)

    Time frame: 8 Days (Part A), 13 Days (Part B)

    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.

  2. Pharmacokinetics (Part A and Part B)

    Time frame: 1 Day (Part A), 6 days (Part B)

    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.

  3. Secondary efficacy (Part C)

    Time frame: 3 days

    Rate of S. aureus clearance following 3 days of treatment with various doses of P128

  4. Re-colonization (Part C)

    Time frame: 14 Days

    Rate of re-colonization by S. aureus 7 and 14 days after the last day of treatment with various doses of P128

Sponsors and collaborators

Lead sponsor

GangaGen, Inc.

Industry

Registry information

Official study title

A Randomized Double-Blind Placebo-Controlled Study to Determine Safety of P128 Applied to Nares of Healthy Volunteers and Safety And Efficacy of Any Patient Including Chronic Kidney Disease Patients Who Are Nasal Carriers of S.Aureus.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2012
Registry last updated
Mar 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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