A first-in-human study to evaluate the safety, tolerability and performance of uncoated and placebo-coated Nanopatches

Phase 1

Completed

• Conditions: Vaccination Delivery Device; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12615000583549
• Lead Sponsor: Vaxxas Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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
11.Subject is pregnant or breast-feeding.
12.A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day.
13.Use of any prescription medication within 7 days, unless approved by the PI. All medications will be documented and reviewed for acceptance by the Investigator or a medically qualified nominee.
14.Use of any investigational drug or device within 30 days or 10 half-lives of the drug, whichever is longer, prior to the Day 0.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite Primary Outcome: To examine the safety and tolerability of uncoated and placebo-coated Nanopatches in healthy volunteers. Safety is assessed by number of Adverse events; Tolerability assessed by observation and measurements of erythema, itching, induration and flaking of skin (Draize scoring system). [For Cohort 1; Observations will begin immediately after application for 2 hours then daily for 6 days after each application then on day 10, 14 and Day 35<br>For Cohort 2; Observations will begin immediately after application then daily for 6 days after application then on day 28]

Secondary Outcome Measures

Name	Time	Method
Composite outcome To assess the pain and acceptability of the Nanopatch administration process in healthy volunteers. This will be assessed by optional Questionnaire administered after application. (Study Specific design); Pain assessed on 100mm VAS. [Assessment will begin immediately after application and will continue for 2 hours. ];To compare sites of application and uncoated versus placebo-coated patches within subjects. This will be assessed by examination and photography<br>[For Cohort 1: examination and photography will be done on Days 0, 3, 7, 10, 14 and 35. <br>For Cohort 2: examination and photography will be done on Days 0, 3, 7, and 28. ];Exploratory Objective: To perform post-application analysis of the nanopatches to investigate skin penetration and performance using scanning electron microscopy and for the placebo-coated nanopatches, residual trehalose content[The patches will be analysed post removal from patient. ]