Nasal carriage of Staphylococcus aures (including MRSA) MedDRA version: 12 Level: LLT Classification code 10067910 Term: Staphylococcal colonisation
Conditions
Interventions
Product Name: HT61 1% gel
Product Code: HY50A
Pharmaceutical Form: Nasal gel
Current Sponsor code: HT61
Other descriptive name: 4-methyl
Sponsors
Helperby Thearapeutics Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 to 85 years inclusive. 2. Judged healthy from a medical history, routine laboratory investigations, vital signs and ECGs. 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. 6. Male or female subjects who are using a medically acceptable method of contraception or of non-childbearing potential (i.e., surgically sterile-bilateral tubal ligation or removal of both ovaries and/or uterus at least 6 months prior to dosing or naturally postmenopausal for at least one year with a Screening FSH level = 40 mIU/L). A negative serum pregnancy test is required at Screening for females. Female subjects Female subjects of childbearing potential must use medically acceptable methods of contraception from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include: • Oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or sub-dermal implants and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}: • A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Medically prescribed topically-applied transdermal contraceptive patch and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository}; • Documented tubal ligation (female sterilisation). In addition, a barrier method {condom or occlu-sive cap (diaphragm or cervical/vault caps) used with spermicidal foam/gel/film/cream/suppository} should also be used; • Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; • Abstinence. Male subjects Male subjects must use medically acceptable methods of contraception if their female partners are pregnant from the time of the first administration of the study medication until 3 months following administration of the last application of study medication. Acceptable methods include: • Condom • If the subject has undergone surgical sterilisation (vasectomy with documentation of azoosper-mia) a condom with spermicidal foam/gel/film/cream/suppository should also be used. • Use acceptable methods of contraception if the male subject’s partner could become pregnant from the time of the first administration of study medication until 3 months following administration of the last application of study medication. The acceptable methods of contraception are as follows: • Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; • Surgical sterilisation (vasectomy with documentation of azoospermia) and a barrier method {condom or occlusive cap (diaphragm or cervical/vault caps) used wi
Exclusion criteria
Exclusion criteria: 1. Any allergic reactions to mupirocin or glycine ester. 2. Any clinically significant skin or other condition or disorder which may affect the conduct or outcome of the study. 3. Clinical significant signs of infected skin diseases, e.g. infected Eczema 4. Carriage of either methicillin sensitive or resistant Staphylococcus aureas in the throat or skin/wound lesion. 5. Abnormal pathology of nasal passages. 6. Any clinically significant allergy or drug intolerance 7. Active hay fever, on-going cold/flu symptoms, including rhinitis. 8. Use of antibiotics for 4 weeks prior to the study drug application or use of concomitant systemic or topical antibiotics. 9. Any medical history or renal insufficiency or hepatic disorder. 10. Any history of history of pet ownership. 11. Are living with children under the age of 10. 12. History or signs or symptoms of any cancer. 13. Participation in a study with an investigational drug within 90 days prior to study drug application on Day 1. 14. 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. 15. Subjects with known or suspected immunodeficiency. 16. Systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to baseline visit. 17. 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. 18. History or presence of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, or neurological disease. 19. A positive HIV 1 & 2 antibodies, Hepatitis B surface antigen, and/or Hepatitis C antibody result. 20. Blood donation or blood loss of more than 600 ml within 90 days prior to dosing on Day 1. 21. Known or suspected drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the efficacy of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with vehicle alone. ; Secondary Objective: • To determine the efficacy of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with 2% mupirocin. • To determined the rate of reduction of colony forming units of nasal Staphylococcus aureus. • To determine the rate of relapse. • To determined the safety and tolerability of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with vehicle alone and 2% mupirocin • To determine the pharmacokinetic profile of HT61 (1%) gel. ;Primary end point(s): • To determine the efficacy of HT61 (1%) gel at two dose frequencies as determined by nasal decolonisation of Staphylococcus aureus in comparison with vehicle alone. | — |
Countries
United Kingdom
Outcome results
None listed