A first-in-human study to evaluate the safety and performance of placebo excipient-coated high-density microarray patches applied by an integrated application device.
- Conditions
- VaccinationsPublic Health - Other public health
- Registration Number
- ACTRN12620000179932
- Lead Sponsor
- Vaxxas Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 43
1.Aged 18-64 years (inclusive).
2.Subject has a Body Mass Index (BMI) within the range 18.0–34.9 kg/m².
3.Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical history, physical examination, and vital signs.
4.Females of childbearing potential and males should either be sexually inactive (abstinent) for 14 days prior to Day 0 and throughout the study or be using one of the following acceptable birth control methods:
i.Surgically sterile (hysterectomy and/or bilateral oophorectomy);
ii.Surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study initiation);
iii.IUD in place for at least 3 months;
iv.Stable hormonal contraceptive for at least 3 months prior to study through study completion;
v.Surgical sterilization (vasectomy) for male participants or for female participant’s partner at least 6 months prior to study
vi.Condom for male participant together with effective contraception for their female partner.
5.Postmenopausal women must have had at least 12 months since their last menstrual period
6.Subject can communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
7.Subject is able and willing to provide written, personally signed and dated informed consent to participate in the study.
1.Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema or sunburn) on forearms, upper arms, or posterior shoulder regions (both arms) which could reasonably obscure potential application sites
2.Subject with known chronic spontaneous urticaria / dermographism
3.Subject with known allergy/sensitivity to ingredients, including gold
4.Previous adverse reaction to fluorescein or synthetic dyes
5.Known predisposition to keloid scar formation
6.History of granulomatous diseases (especially sarcoidosis and granuloma annulare)
7.History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, or haematological disorders
8.History of malignancy, other than basal cell skin cancer.
9.An active medical condition (which is deemed as clinically significant) that is under evaluation or treatment, or a recent illness, a chronic illness, or an autoimmune disease
10.History of Hepatitis B, Hepatitis C, or HIV infection
11.History of abnormal bleeding tendencies or thrombophlebitis unrelated to venepuncture or intravenous cannulation
12.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
13.History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
14.Subject has donated blood or plasma or clinically significant blood loss within 60 days prior to screening visit
15.Subject has received blood or plasma within 60 days prior to screening visit
16.Subject is pregnant or breast-feeding
17.A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day
18.Use of any prescription medication (except for contraceptives) within 7 days, unless approved by the PI. All medications will be documented and reviewed for acceptance by the PI or a medically qualified nominee
19.Use of any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Day 0
20.A Vaxxas employee
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary study endpoint (outcome)<br>•Number of subjects with SAEs deemed possibly, probably, or definitely related to treatment administration.<br>•Number of subjects with AEs deemed possibly, probably, or definitely related to treatment administration.<br>•Local skin response (erythema, oedema, redness extent, induration, skin flaking, application site visibility) and photo imaging thirty minutes post-application. Local skin response and other recorded adverse events will be assessed at Day 7 (±1 day). Any local skin responses still present at Day 28 (±2 days) will be followed up to resolution, or until the subject is lost to follow-up. <br>the outcome for Part A is the same as for Part B but with an increased number of subjects in part B[30 mins post application, Day 7 post application and Day 28 post application]
- Secondary Outcome Measures
Name Time Method Post-application analysis of HD-MAP engagement with skin using Scanning Electron Microscopy (SEM).<br><br>the outcome for Part A is the same as for Part B but with an increased number of subjects in part B[30 mins post application, Day 7 post application and Day 28 post application];Post-application analysis of delivered dose from HD-MAP to skin using residual fluorescein sodium dye on the HD-MAP.[30 mins post application, Day 7 post application and Day 28 post application];Skin assessment using non-invasive methods, such as dermatoscope, Trans epidermal water loss and Epsilon.[30 mins post application, Day 7 post application and Day 28 post application]