MedTrace Logo

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

NCT01746654 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2016-03-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

P128-0.1 mg

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.

DRUG

P128-0.3 mg

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.

DRUG

P128-1.0 mg

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • GangaGen, Inc.

    lead INDUSTRY

Principal Investigators

  • Dale A Fisher, MBBS, FRACP · National University Hospital, Singapore

  • Surinder Kher, MD · Manipal Acunova Ltd, Bangalore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01746654 on ClinicalTrials.gov