None listed
Conditions
Brief summary
This study is primarily intended to investigate the safety and tolerability of platelet-derived extracellular vesicles (PLEXARIS) following intradermal injection around a skin punch biopsy in a healthy participant. PLEXARIS will be directly compared to a matched placebo formulation in each participant. Additionally, the study aims to evaluate the time to wound closure between the treated and control biopsies, and assess the presence of scaring, erythema or infection at the wound site.
Interventions
The active drug is Plexaris (formulation of platelet-derived extracellular vesicles). One to two weeks prior to drug administration, participants will be required to undergo a procedure to extract a sample of their own platelets, which will then be processed into the Plexaris drug product. The drug product will be patient-specific (autologous) for this study.
Each patient receives a punch biopsy in the upper underside of both their arms to form a small wound. The 0.3 mg/mL Plexaris drug produc
The active drug is Plexaris (formulation of platelet-derived extracellular vesicles). One to two weeks prior to drug administration, participants will be required to undergo a procedure to extract a sample of their own platelets, which will then be processed into the Plexaris drug product. The drug product will be patient-specific (autologous) for this study. Each patient receives a punch biopsy in the upper underside of both their arms to form a small wound. The 0.3 mg/mL Plexaris drug product is administered by intradermal injection in two locations adjacent to the punch biopsy wound in the non-dominant arm. The placebo formulation is administered by intradermal injection in two locations adjacent to the punch biopsy wound in the dominant arm. The same procedure is followed for Cohort 1 and Cohort 2, however Cohort 2 will receive a further punch biopsy seven days after the initial biopsy. This will partially intersect the original biopsy to enable the partially healed wound tissue to be extracted for analysis.
Sponsors
Exopharm Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
• 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
Exclusion criteria
• 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
Outcome results
None listed