Infectious DiseasePhase 1/2NCT01746654
Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients
A Phase 1/2 study testing P128-0.1 mg, P128-0.3 mg and P128-1.0 mg in people with Infectious Disease and Bacterial Infections, run by GangaGen, Inc. at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infectious Disease, Bacterial Infections
- What is being tested?
- P128-0.1 mg, P128-0.3 mg and P128-1.0 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2012to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy human volunteer
- Any patient clinically stable who are nasal carrier of S. aureus or MRSA including Chronic Kidney disease patients stable on dialysis
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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 Any Patient Including Chronic Kidney Disease Patients Who Are Nasal Carriers of S.Aureus.
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.
Read the 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 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.
- Conditions
- Infectious Disease, Bacterial Infections
- Being tested
- P128-0.1 mg, P128-0.3 mg, P128-1.0 mg, Placebo
- Keywords
- S.aureus, Methicillin Resistant S.aureus (MRSA), Nasal carrier status, Prophylaxis
- Medical subject headings
- Communicable Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P128-0.1 mgDrug
Also called Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D
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.
P128-0.3 mgDrug
Also called Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D
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.
P128-1.0 mgDrug
Also called Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D
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.
PlaceboDrug
Also called Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part D
Placebo was administered to both nares once in part A, multiple times in Part B and Part C, Once in part D
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 8 Days (Part A), 13 Days (Part B)
Pharmacokinetics (Part A and 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.
Measured: 1 Day (Part A), 6 days (Part B)
Secondary efficacy (Part C)
Rate of S. aureus clearance following 3 days of treatment with various doses of P128
Measured: 3 days
Re-colonization (Part C)
Rate of re-colonization by S. aureus 7 and 14 days after the last day of treatment with various doses of P128
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- GangaGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dale A Fisher, MBBS, FRACP, Principal investigator, National University Hospital, SingaporeSurinder Kher, MD, Study director, Manipal Acunova Ltd, Bangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746654
- Sponsor's protocol ID
- P128-001
- Status last verified
- Mar 2016
- First submitted
- 5 Dec 2012
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Any Patient Including Chronic Kidney Disease Patients Who Are Nasal Carriers of S.Aureus.
- ClinicalTrials.gov ID
- NCT01746654
- Acronym / sponsor ID
- P128-001
- Conditions
- Infectious Disease, Bacterial Infections
- Keywords
- S.aureus, Methicillin Resistant S.aureus (MRSA), Nasal carrier status, Prophylaxis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- GangaGen, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| P128-0.1 mg | Experimental | Drug: P128-0.1 mgThree 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) |
| P128-0.3 mg | Experimental | Drug: P128-0.3 mgThree 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) |
| P128-1.0 mg | Experimental | Drug: P128-1.0 mgThree 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) |
| Placebo | Placebo comparator | Drug: PlaceboThree 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) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy human volunteer
- Any patient clinically stable who are nasal carrier of S. aureus or MRSA including Chronic Kidney disease patients stable on dialysis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P128-0.1 mgAlso: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part DP-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 | P128-0.1 mg |
| P128-0.3 mgAlso: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part DP-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 | P128-0.3 mg |
| P128-1.0 mgAlso: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part DP-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 | P128-1.0 mg |
| PlaceboAlso: Single dose in Part A, Multiple doses in Part B, Multiple doses in Part C, Single dose in Part DPlacebo was administered to both nares once in part A, multiple times in Part B and Part C, Once in part D | Drug | Placebo |
Primary outcome
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.
4 secondary outcomes
Immunogenicity (Part A, Part B and Part C)
Time frame: 8 Days (Part A), 13 Days (Part B)
Pharmacokinetics (Part A and Part B)
Time frame: 1 Day (Part A), 6 days (Part B)
Secondary efficacy (Part C)
Time frame: 3 days
Re-colonization (Part C)
Time frame: 14 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale A Fisher, MBBS, FRACP principal investigator
National University Hospital, Singapore
Surinder Kher, MD study director
Manipal Acunova Ltd, Bangalore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing P128-0.1 mg, P128-0.3 mg and P128-1.0 mg in people with Infectious Disease and Bacterial Infections, run by GangaGen, Inc. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.