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Microdermics Inc. is a British Columbia-based Canadian incorporation primarily focusing on microneedle-based painless and effective drug delivery systems.The Microneedle Adapter (model UAR-2S) is a single-use disposable medical device intended to provide a mechanism for intradermal bolus fluid delivery when used with a standard syringe with a Luer-lock tip connection. The Microneedle Adapter consists of a single-use gold-coated metallic microneedle integrated within the microneedle adapter with fluidic connections to a standard Luer syringe mount. The primary function of the Microneedle Adapter is to guide the microneedle into the skin in a controlled manner for successful insertion passing the stratum corneum layer. The fluid loaded onto the syringe can then be injected precisely intradermally into the skin.The primary objective of this study is to evaluate the performance of the Microneedle Adapter in healthy subjects in 3 different injection sites. Pain perception of the Microneedle Adapter will be a key secondary outcome, compared with the control device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Each subject will undergo ID administration by Microneedle Adapter (Model UAR-2S) and hypodermic needle + syringe of 100 μL injectable saline into 3 different regions: the inner forearm, the deltoid and the thigh, at three (3) study visits. A total of 4 injections (2 x 50 μL saline and 2 x 100 μL saline) will be administered to each study participant in the injection sites (2 injections per inner forearm/deltoid/thigh and 2 injection per device). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle Adapter (Model UAR-2S) | Device | Investigational device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the performance of the Microneedle Adapter in the inner forearm | Consistency of injected fluid volume by gravimetric technique | 1 day |
| Evaluate the performance of the Microneedle Adapter in the deltoid | Consistency of injected fluid volume by gravimetric technique | 1 day |
| Evaluate the performance of the Microneedle Adapter in the thigh | Consistency of injected fluid volume by gravimetric technique | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate pain perception of the Microneedle Adapter vs. the control device | Assessment of pain intensity using Numeric Rating Scale (NRS), a verbal 0-10 point scale where 0 means no pain and 10 means worst possible pain | 1 day (post needle injection and post fluid injection) |
| Collection and evaluation of adverse events [safety and tolerability] |
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Inclusion Criteria:
Healthy male or female, 19-65 years old inclusive, non-smoker (no use of tobacco products within 3 months prior to screening)
Able to understand the informed consent form and willing to participate in study
Intact skin at the sites of injection
Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive method throughout the study and for 30 days after the last study drug administration:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Larouche, MD | inVentiv Health Clinique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| inVentiv Health Clinique | Québec | Quebec | G1P 0A2 | Canada |
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| ID | Term |
|---|---|
| D009339 | Needles |
| D013594 | Syringes |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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Subjects will be first randomized to receive each of the injection (A, B, C, and D) in each of the 3 visits of the study, according to the block randomization scheme produced by inVentiv. The following sequences will be used: 1st (upper right location), 2nd (lower right location), 3rd (upper left location) and 4th lower left location) where:
A. Investigational device with 50 μL saline B. Control device with 50 μL saline C. Investigational device with 100 μL saline D. Control device with 100 μL saline
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| Hypodermic needle + syringe |
| Device |
Control device |
|
Events will be reported by severity and causality |
| 2 weeks |
| Assessment of contact dermatitis using Draize Scale [safety and tolerability] | Draize scale has 4 components (Hemorrhage/petechiae, Erythema, Edema, Pruritus) with scores 0 up to 5, where 5 indicates worst event | 2 weeks |
| Assess end-user satisfaction in using the Microneedle Adapter and obtain feedback on the device's design | Assessment of end-user usability using the modified System Usability Scale (mSUS), a 10-question scale producing a normalized score 0 to 100, where 0 indicates high user dissatisfaction and 100 indicates high user satisfaction | 2 weeks |