ACTRN12615000583549
Completed
Phase 1
A first-in-human study to evaluate the safety, tolerability and performance of uncoated and placebo-coated Nanopatches
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vaccination Delivery Device
- Sponsor
- Vaxxas Pty Ltd
- Enrollment
- 18
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Aged 18\-45 years (inclusive).
- •2\.Subject has a BMI within the range 18\.0–30\.0 kg/m2
- •3\.Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical
- •history, physical examination, vital signs and laboratory evaluation (haematology or biochemistry)
- •4\.Adequate venous access in their left or right arms to allow collection of a number of blood samples.
- •5\.Subject is fair\-skinned.
- •6\.Subject is able to communicate effectively with study personnel and is considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
- •7\.Able and willing to provide written, personally signed and dated informed consent to participate in the study.
Exclusion Criteria
- •1\.Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions on both forearms and deltoid regions which could reasonably obscure application site reactions.
- •2\.Known Predisposition to keloid scar formation.
- •3\.History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease or haematological disorders.
- •4\.History of malignancy, other than non\-melanoma skin cancer.
- •5\.An active medical condition that is under evaluation or treatment, or a recent illness, a chronic illness, an autoimmune disease or had major surgery within the last year.
- •6\.History of Hepatitis B, Hepatitis C or HIV infection or clinical laboratory serology is positive for Hepatitis B surface antigen, Hepatitis C or HIV antibodies.
- •7\.History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation,
- •8\.Receiving chronic treatment with immune\-suppressive therapy (asthma inhalers and topical corticosteroids are permitted). All medications will be documented and reviewed for acceptance by the Investigator or a medically qualified nominee.
- •9\.History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study.
- •10\.Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit
Outcomes
Primary Outcomes
Not specified
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