None listed
Conditions
Brief summary
A Placebo controlled Phase I study to demonstrate the safety of a therapy using nano vesicles purified from human donor platelets and administered to healthy adult volunteers.
Interventions
The intervention 'PLEXARIS OS' is a non-autologous, human donor platelet derived Extracellular Vesicle product. The platelets used to derive the Extracellular Vesicles are sourced from Australian blood donors.
Each participant receives a bilateral 4mm punch biopsy induced wound to their upper inner arms. The Product dose of 0.3 mg/mL is administered by subcutaneous injection to one of the two punch biopsy induced wounds of each participant. The Placebo is identically administered to the other
The intervention 'PLEXARIS OS' is a non-autologous, human donor platelet derived Extracellular Vesicle product. The platelets used to derive the Extracellular Vesicles are sourced from Australian blood donors. Each participant receives a bilateral 4mm punch biopsy induced wound to their upper inner arms. The Product dose of 0.3 mg/mL is administered by subcutaneous injection to one of the two punch biopsy induced wounds of each participant. The Placebo is identically administered to the other punch biopsy induced wound of the participant as a comparator. Both the product and placebo are a single dose administration performed at Day 0 and each participant is monitored by follow-up to 30 days post administration. The subcutaneous injection is administered by the Principal Investigator or delegate (qualified physicians) both of who are blinded to the product and placebo. The participant is blinded to the administration of the product and placebo. The wound is assessed at each follow up visit by a qualified dermatologist who is blinded to the wounds that received the product and placebo. The intervention is assessed in all participants to 30 days with follow up at Days 3, 7, 14 and 30. The participant consent form (PICF) contains details of the product source and its composition, the risks associated with the source material used for the product, what is involved in the study, how product is administered, how the punch biopsy is performed, blood samples taken for lab tests, schedule of required follow up visits and what is expected of the participant to adhere to the study. The health status of each participant will be assessed at each follow up visit by performing a physical examination and assessing their vital signs (Blood Pressure, Respiratory Rate, Body Temperature and Pulse Rate). A blood sample will also be taken at each follow up visit to assess haematological (FBE & clotting factors) and biochemical characteristics (LFT, KFT, etc) and monitor for any change in baseline results.
Sponsors
Exopharm ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed