An open-label, multiple dose, efficacy study of HT61 in combination with marketed antibiotics, applied to the anterior nares in subjects with nasal carriage of Staphylococcus aureus (S. aureus). - (duplicate) An efficacy study of HT61.

• Conditions: asal carriage of Staphylococcus aureus (including MRSA); MedDRA version: 14.1Level: LLTClassification code 10067914Term: Staphylococcal colonisationSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2011-002438-38-GB
• Lead Sponsor: Helperby Therapeutics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-23
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

To be eligible for inclusion, each subject must fulfil each of the following criteria:

1.Male or female between 18 to 65 years inclusive.
2.Judged healthy from a medical history, routine laboratory investigations, vital signs and 12-lead ECG.
3.Capable of giving informed consent.
4.Able to understand, willing and likely to fully comply with study procedures and restrictions.
5.Able to attend all visits and complete the study and comply with the necessary restrictions.
6.Male or female subject who is using a medically acceptable method of contraception or females of non-childbearing potential.
7.Treatment area amenable to topical treatment, i.e. anterior nares should be free of any obstructions and tissue damage.
8.Subject who tests positive for S. aureus carriage in both right and left anterior nares
9.Subject who tests negative for S. aureus carriage in the throat.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Subjects will be excluded from the study if any of the following criteria are met at screening:

1.Subject has wound lesions.
2.Any clinically significant allergy, including allergy to Arachis oil (peanut oil), neomycin, chlorhexidine, mupirocin or glycerine ester or drug intolerance.
3.Active hay fever, on-going cold/flu symptoms, or a clinically significant history or currently active rhinitis.
4.Any structural abnormalities of the nose or nasal piercings
5.Use of concomitant systemic or topical antibiotics or systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to Day 1. Use of any prescribed medication in the 2 weeks prior to Day 1 and use of any non-prescribed medication (including herbal remedies, nutritional supplements or vitamins and minerals) in the 1 week prior to Day 1 (inclusion of subjects who have taken medication will be assessed on a case-by-case basis in relation to the safety aspects and objectives of this study).
6.Participation in a clinical study where the final dose of a New Chemical Entity occurred within the previous 16 weeks to Day 1; or where the final dose of a marketed drug occurred within the previous 12 weeks or at least 5 half lives (whichever is longest) of Day 1.
7.Clinically significant history or presence of any: haematological, dermatological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, neurological disease; any known or suspected immunodeficiency; any history or signs or symptoms of cancer; or a history or presence of any other disorder that may affect the conduct or outcome of the study.
8.History or pre-existing prolongation of QTc interval, cardiac arrhythmias or conduction defects on a 12-lead ECG.
9.A positive HIV 1 & 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result.
10.Donation of 450ml or more blood within the previous 12 weeks to Day 1.
11.Known or suspected drug abuse including a history of regular alcohol consumption exceeding an average weekly intake of alcohol greater than 21 units. One unit is equivalent to a half-pint of beer or one 25 mL measure of spirits or one small glass of wine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •The primary objective is to assess the efficacy of HT61 when given concurrently with marketed antibiotics Bactroban and Naseptin. ;Secondary Objective: •Assess the safety of HT61<br><br>•To measure the plasma concentration of HT61<br>;Primary end point(s): The primary endpoint is the time to 99% reduction in colony forming units of nasal S. aureus following treatment.