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Clinical Trial Details

Trial ID: L1700
Source ID: NCT01746654
Associated Drug: P128-0.1 Mg
Title: Safety & Efficacy of an Antibacterial Protein Molecule Applied Topically to the Nostrils of Volunteers and Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Infectious Disease|Bacterial Infections
Interventions: DRUG: P128-0.1 mg|DRUG: P128-0.3 mg|DRUG: P128-1.0 mg|DRUG: Placebo
Outcome Measures: Primary: 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: 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., 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., 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, 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, 14 Days
Sponsor/Collaborators: Sponsor: GangaGen, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 74
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2012-12
Completion Date: 2015-12
Results First Posted:
Last Update Posted: 2016-03-07
Locations: National University Hospital, Singapore, Singapore
URL: https://clinicaltrials.gov/show/NCT01746654