First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133

Официальное название

A Randomized Double-blind Placebo-controlled First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy of a Recombinant Chimeric Bacteriophage Endolysin HY-133 With an Extended Phase to Evaluate Effects of the Nasal Microbiome

Обзор

In this clinical trial we will test a new approach for decolonization of S. aureus. As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned.

Вмешательства

• Препарат HY_133
  A recombinant chimeric bacteriophage endolysin HY-133
• Препарат Placebo
  Placebo

Первичные конечные точки

• ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject [Срок оценки: baseline, pre-intervention/procedure/surgery, up to Day15]

Критерии участия

Критерии включения

• Must be ≥ 18 years at the time of signing the informedconsent.
• Understand and voluntarily sign an informed consent document prior to any study related
• assessments/procedures.
• Nasal colonization with methicillin-susceptible S. aureus (MSSA)
• Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15

Критерии исключения

• Nasal colonization with methicillin-resistant S. aureus (MRSA)
• Nasal traumata including nose penetrating foreign bodies (e.g. piercings)
• Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease
• Acute or known chronic diseases of the nose or the paranasal sinuses
• Acute or known chronic diseases of other parts of the respiratory tract
• Running nose due to other reasons (e.g. allergic diseases)7. Positive serological HIV, hepatitis A, B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
• Women during pregnancy and lactation.
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Participation in other clinical trials or observation period of competing trials, in the 12 weeks prior to screening.
• Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test
• Systemic antibiotic treatment in the 12 weeks prior to screening.
• Intranasal eradication therapy in the 12 weeks prior to screening.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Германия · 2 центра

• Department of Dermatology, University Hospital Tuebingen — Tübingen
• Department of Dermatology — Tübingen

Идентификаторы

NCT: NCT06290557 · HY-133 · 2023-507737-17-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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