ACTRN12620000944932已完成1 期
A prospective, Randomised, Double Blind, Placebo Controlled, single dose, single site phase I study to assess the safety and biological activity of a Human non-autologous platelet derived Extracellular Vesicle therapy vs placebo on wound healing rate following skin punch biopsy in healthy volunteer adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Exopharm ltd
- 入组人数
- 11
研究概览
简要总结
This phase I study of the nano vesicle product (Plexaris OS) purified from human donor platelets was primarily aimed to demonstrate the safety of the product administered to healthy adult volunteers as a single dose subcutaneously at the site of a skin punch biopsy induced wound. There were no untoward or unexpected safety events reported during the study with all 11 enrolled participants remaining healthy throughout and at the completion of their 30 day follow up period post administration of the product. All induced wounds had successfully healed without skin defects nor abnormal scarring or abnormal cosmetic appearance. This study demonstrated the safety of the nano vesicle Plexaris OS product derived from human donor platelets in a cutaneous wound healing condition with a group of healthy volunteers, concluding that there are no safety risks associated with the use of the product
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 64 Years（—）
- 性别
- All
入选标准
- •Healthy adults aged 18 to 64 years of age
- •Able to read, understand and sign Participant Information and Consent Form
- •Eligible for punch biopsy
- •Suitable health status to participate in the study, determined by medical history, vital signs, physical examination and within acceptable test range for general haematological laboratory profiles and general biochemistry laboratory profiles for metabolism & hormones
- •No history of diabetes or cardiac disease (e.g. hypertension, arrhythmia, etc) which can impede and delay wound healing.
- •No history of any bleeding or coagulation disorders.
- •No history of malignancy, except for fully excised Squamous Cell Carcinoma and Basal Cell Carcinoma.
- •No active or chronic diseases/disorders requiring systemic treatment, no history of hospitalisation 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 of child-bearing potential must be non-pregnant, (as confirmed by ß-HCG serum test at screening visit and urine test at dosing visit 1) and non-lactating.
- •All females of childbearing potential, and male participants with female partners of child-bearing potential, must agree to take medically acceptable contraception measures whilst on the treatment and for 30 days following treatment.
- •Agree to maintain wound dressings as per study instructions
排除标准
- •Existing scars in study area or evidence of infection;
- •Evidence of existing chronic dermatological conditions such as psoriasis and eczema.
- •Participation in another clinical study or prior participation within 3 months of first visit;
- •History of any clinically important severe allergic or anaphylactic reaction or known or suspected hypersensitivity to compounds similar to the investigational product;
- •History of clinically important or uncontrolled systemic disease or condition as determined by the investigator;
- •Concurrent administration of NSAIDs, Immunosuppressive agents, anticoagulation therapy including low dose aspirin or systemic corticosteroids therapy.
研究者
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