ACTRN12619001378112终止1 期
A Prospective open-Label, single dose proof of concept study to Evaluate the safety, tolerability and biological activity of platelet-derived extracellular vesicles, on the augmentation of wound healing rate and effect on scar formation following skin punch biopsy in healthy volunteer adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Exopharm Ltd
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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