NCT04767321

A Study to Evaluate the Safety and Efficacy of 3% LTX-109 for Nasal Decolonisation of Staphylococcus

A Phase I/IIa, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Exploratory Efficacy of 3% LTX-109 Compared to Placebo for Nasal Decolonisation of Staphylococcus Aureus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Pharma Holdings AS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase I/IIa, double-blind, placebo-controlled, randomised study designed to evaluate the safety, tolerability, exploratory efficacy and exposure of LTX-109 administered topically to the anterior nares in subjects with persistent carriage of S. aureus (methicillin-susceptible S. aureus \[MSSA\] and/or methicillin-resistant S. aureus \[MRSA\]).

Detailed description

Approximately 60 subjects will be screened to achieve 24 persistent MSSA and/or MRSA carriers and 16 randomised and dosed subjects randomized 3:1, active to placebo. Eligible subjects will be admitted to the clinic on Day 1 for randomisation and dosing and will remain at the clinic until Day 2. Following nasal and perineum swabs and a chlorhexidine (Hibiscrub®) shower, the investigational medicinal product (IMP) will be applied topically to both nostrils by a qualified health professional 4 times during a six hour period (every two hours at 0, 2, 4 and 6 hours) on Day 1. Subjects will come back to the research clinic on Day 3, Day 4, Day 8 and Day 15 (Visits 4 to 7) for safety, tolerability and efficacy assessments and for blood sampling for bioanalysis. On Day 5 and Day 6, subjects will take a chlorhexidine shower at home. A final end-of-study visit (Visit 8) will take place on Day 22 (±3 days) or after early withdrawal. All subjects will be instructed to wash the body and hair with chlorhexidine body wash and shampoo at the clinic on Day 1 (prior to the first dose) and on Day 2. Prior to leaving the clinic on Day 2, subjects will be provided with chlorhexidine body wash and shampoo for body and hair wash at home on Day 3 (prior to Visit 4), on Day 4 (prior to Visit 5) and on Day 5 and Day 6. Each subject is expected to participate in the study for approximately 50 days including a 28 day screening period

Conditions

• Nasal Decolonization of Staphylococcus Aureus

Interventions

Type	Name	Description
DRUG	LTX-109 gel, 3% w/w	LTX-109 gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
DRUG	Placebo	Placebo gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.

Timeline

• Start date: 2021-02-22
• Primary completion: 2021-03-23
• Completion: 2021-06-01
• First posted: 2021-02-23
• Last updated: 2021-08-30

Locations

1 site across 1 country: Sweden