A Phase I clinical study to evaluate safety, tolerability and biological activity of platelet-derived extracellular vesicles on wound healing in healthy adults
- Conditions
- Wound healingSkin - Normal skin development and function
- Registration Number
- ACTRN12619001378112
- Lead Sponsor
- Exopharm Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 3
• Adult patients aged 18 – 45 years
• Able to read, understand and sign Participant Information and Consent Form
• Suitable health status to participate in the study, determined by non-clinically significant Laboratory profiles, medical history, vital signs, physical examination as deemed by the Principal Investigator.
• No history of cardiac disease.
• No active or chronic diseases/disorders, no history of hospitalization for illness within the six months prior to enrolment into study, and no major surgery within the 6 months
prior to enrolment into study
• Females must be non-pregnant or non-lactating in the last 12 months, postmenopausal for at least 1 year (as confirmed by follicle stimulating hormone [FSH]), or surgically sterile for at least 6 months prior to dosing.
• All male and females of childbearing potential must agree to use two forms of acceptable contraception from the time of signing informed consent until 30 days after study completion. Acceptable forms of contraception are: a nonhormonal
intrauterine device (IUD); contraceptive sponge; diaphragm; cervical cap; a male sexual partner who agrees to use a male condom; a sterile sexual partner; or complete abstinence. Hormonal contraceptives may not be used from the time of signing the informed consent until end of treatment period. Female Participants of childbearing potential must have a negative urine pregnancy test result at the screening visit and at
Visit 4 . Male Participants must use contraception or practice complete abstinence for 30 days after dosing and must not donate sperm during this time.
• Agreeing to maintain wound dressings as per study instructions
Additional inclusion criteria specific for the donation of platelets:
• Height no less than 168 cm and weight no less than 70 kg as determined at screening visit (Visit 0)
• Platelet count no less than 215,000 platelets/µL
• History of any clinically important cardiac, endocrinologic, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator
• Chronic inflammatory disease
• Chronic infectious disease
• History of keloid formation
• Concurrent administration of NSAIDs, Immunosuppressive agents, anticoagulation therapy or systemic corticosteroids therapy
• Acute disease state (e.g., nausea, vomiting, diarrhoea) within 7 days of Study Visit 1.
• No personal history of cardiac arrhythmia, epilepsy and no family or personal history of prolonged QT syndrome
• History of any clinically important severe allergic or anaphylactic reaction or known or suspected hypersensitivity to compounds similar to the investigational product. Use of any
investigational or prescription drug within 30 days of Study Visit 1.
• Participation in another clinical trial or administration of any investigational product or experimental treatment within 12 weeks or 5 half-lives (whichever is longer) preceding Study Visit 1.
Additional exclusion criteria specific for the donation of platelets:
• Acute disease state (e.g., nausea, vomiting, diarrhea) within 7 days of proposed apheresis date
• Dental treatments (i.e. cleaning, scaling, fillings, etc) or root canals in the preceding 7 days
• Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
• Positive serologic screening for HTLV (human T-lymphotropic virus) and syphilis
• Any other findings that the Investigator considers precludes the participant from taking part in the study.
• Veins that are not suitable for a large gauge needle used during apheresis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method