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

NCT04767321 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-08-30

No results posted yet for this study

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 \[MRSA\]).

Conditions

  • Nasal Decolonization of Staphylococcus Aureus

Interventions

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.

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Pharma Holdings AS

    lead INDUSTRY

Principal Investigators

  • Johan Nilsson, MD · CTC Clinical Trial Consultants AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-22
Primary Completion
2021-03-23
Completion
2021-06-01

Countries

  • Sweden

Study Locations

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Entities

Drugs

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 NCT04767321 on ClinicalTrials.gov