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.

Vaxxas Pty Ltd0 sites43 target enrollmentFebruary 17, 2020

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2020

End Date

October 14, 2020

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.

•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