Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

Inclusion Criteria

• •Both cohorts:
• •Type 1 or type 2 diabetes mellitus with glycated hemoglobin (HbA1c) ≤10, 5%
• •Suitable physical and mental health as determined by the investigator based on medical history and general physical examination.
• •Subjects must be medically stable based on clinical laboratory tests, medical history and vital signs. Clinical laboratory tests should be within normal values or not clinically significant, unless directly related to the condition of diabetes.
• •Female subjects must fulfil one of the following criteria:
• •1. At least 1 year post-menopausal (amenorrhea \>12 months prior to screening);
• •2. Surgically sterile (bilateral oophorectomy or hysterectomy);
• •3. If of childbearing potential, must agree to use a highly effective method of birth control from screening until 14 days after the last administration of IP.
• •Female subjects of childbearing potential must have a negative pregnancy test at screening.
• •Male subjects with a female partner of child-bearing potential or pregnant partner must agree to use a condom from screening until 14 days after the last IP application.
• •ICF signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose of, and procedures required for the study and is willing to participate in the study.
• •Part A:
• •\- Non-infected diabetic foot ulcer perfusion grade 1, depth grade 1 and infection grade 1 according to PEDIS classification.
• •Part B
• •Infected diabetic foot ulcer meeting perfusion grade 1 or 2, depth grade 1 or 2 and infection 2 or 3,except if presence of abscess, fasciitis, osteomyelitis, and septic arthritis, according to PEDIS definition.
• •Infected with at least one bacterial strain susceptible to bacteriophage cocktail assessed from culture.