Staphylococcus aureus carriage. MedDRA version: 9.1 Level: LLT Classification code 10058588 Term: Bacterial culture positive
Conditions
Interventions
Product Name: HT61 (1%) gel
Product Code: HY50A
Pharmaceutical Form: Gel
Current Sponsor code: HT61
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 1-
Sponsors
Helperby Therapeutics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 to 80 years 2. Following verbal & written information about the trial, the subject has signed & dated informed consent before any study related activity was carried out. 3. Subject legally competent and able to communicate effectively with the study personnel 4. Male subject should be abstinent or should be using an effective method of contraception, or partner(s) should be post-menopausal or have a hysterectomy or should use an effective method of contraception. Female subjects should be post menopausal or post –hysterectomy. 5. Microbial diagnosis of nasal carriage of Staphylococcus aureus. 6. Treatment area amenable to topical treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of any skin or other condition or disorder that may affect the conduction or outcome of the study 2. Clinical Signs of infected skin diseases, e.g. infected Eczema 3. Carriage of either methicillin sensitive or resistant Staphylococcus aureus in the throat 4. Abnormal pathology of nasal passages 5. Any clinically significant allergy or drug intolerance 6. Active hay fever, on-going cold/flu symptoms, including rhinitis 7. Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics 8. Known or suspected severe renal insufficiency or severe hepatic disorders. 9. Subject with history/signs/symptoms of cancer, including melanoma skin cancers, but excluding other skin cancers 10. Current participation or within less than 30 days in any other interventional clinical trial. 11. Subjects known or suspected of not being able to comply with trial protocol (e.g. alcoholism, drug dependency, or psychological state). 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 measure of spirits or one glass of wine. 12. Subjects with known or suspected immunodeficiency. 13. Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit 14. intranasal steroids for rhinitis 15. Subjects who have received treatment with any non–marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to baseline visit 16. Current history or presence of clinically significant haematological, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, or neurological disease 17. Blood donation or blood loss of more than 600 ml within 90 days prior to dosing on Day 1. 18. Known or suspected drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of either once only treatment or three consecutive treatments at one and half hour intervals, with 70 µl of HT61 (1%) gel or vehicle in each anterior nares of the nostril in a panel of twelve subjects, with sensitive or resistant nasal carriage of Staphylococcus aureus.;Secondary Objective: To determine the safety and local tolerability of either once only treatment or three consecutive treatments at one and half hour intervals with 70 µl of HT61 (1%) gel or vehicle in each nostril in a panel of twelve subjects with nasal carriage of Staphylococcus aureus.;Primary end point(s): 1. Levels of absorbed HT61 in blood plasma at baseline and after 30min, 1h, 2h, 4h, 6h (single application only), 1d, 2d and 7 days after the last application of the investigational medicinal product. 2. Adverse events (AEs) will be monitored throughout the study 3. Pathology of the nasal passages assessed by an ENT specialist at specified time points as outlined in study flow charts A and B 4. ECG;s and vital signs at specified time points as outlined in study flow charts A and B 5. Effect of HT61 on clinical chemistry and liver function at specified time points as outlined in study flow charts A and B. 6. Urinalysis at specified time points as outlined in study flow charts A and B. | — |
Countries
United Kingdom
Outcome results
None listed