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

NCT01746654 | Completed Phase 1 DMC

• 1 other identifier: P128-001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Infectious Disease; Bacterial Infections

Keywords

S.aureus; Methicillin Resistant S.aureus (MRSA); Nasal carrier status; Prophylaxis

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

• Immunogenicity (Part A, Part B and Part C)

  8 Days (Part A), 13 Days (Part B)

• Pharmacokinetics (Part A and Part B)

  1 Day (Part A), 6 days (Part B)

• Secondary efficacy (Part C)

  3 days

• Re-colonization (Part C)

  14 Days

Study Arms (4)

P128-0.1 mg

EXPERIMENTAL

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)

Drug: P128-0.1 mg

P128-0.3 mg

EXPERIMENTAL

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)

Drug: P128-0.3 mg

P128-1.0 mg

EXPERIMENTAL

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)

Drug: P128-1.0 mg

Placebo

PLACEBO COMPARATOR

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)

Drug: Placebo

Interventions

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.

Also known as: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

P128-0.1 mg

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.

Also known as: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

P128-0.3 mg

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.

Also known as: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

P128-1.0 mg

Placebo DRUG

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

Also known as: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GangaGen, Inc.: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Communicable Diseases; Bacterial Infections

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Study Officials

• Dale A Fisher, MBBS, FRACP

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

• Surinder Kher, MD

  Manipal Acunova Ltd, Bangalore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 11, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

SG (1)