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Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects

An investigational wearable injector (WI), the BD Libertas Wearable Injector (BD Libertas is a trademark of Becton, Dickinson and Company), was evaluated in an early feasibility clinical study for functional performance, tissue effects, subject tolerability, and acceptability of 5 mL, non‐Newtonian...

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Autores principales: Woodley, Wendy D., Yue, Wen, Morel, Didier R., Lainesse, Audrey, Pettis, Ronald J., Bolick, Natasha G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212760/
https://www.ncbi.nlm.nih.gov/pubmed/33278331
http://dx.doi.org/10.1111/cts.12946
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author Woodley, Wendy D.
Yue, Wen
Morel, Didier R.
Lainesse, Audrey
Pettis, Ronald J.
Bolick, Natasha G.
author_facet Woodley, Wendy D.
Yue, Wen
Morel, Didier R.
Lainesse, Audrey
Pettis, Ronald J.
Bolick, Natasha G.
author_sort Woodley, Wendy D.
collection PubMed
description An investigational wearable injector (WI), the BD Libertas Wearable Injector (BD Libertas is a trademark of Becton, Dickinson and Company), was evaluated in an early feasibility clinical study for functional performance, tissue effects, subject tolerability, and acceptability of 5 mL, non‐Newtonian ~ 8 cP subcutaneous placebo injections in 52 healthy adult subjects of 2 age groups (18–64 years and ≥ 65 years). Randomized WI subcutaneous injections (n = 208, 4/subject) were delivered to the right and left abdomen and thigh of each subject, 50% (1 thigh and 1 abdomen) with a defined movement sequence during injection. Injector functional performance was documented. Deposition was qualified and quantified with ultrasound. Tissue effects and tolerability (pain) were monitored through 24 hours with corresponding acceptability questionnaires administered through 72 hours. WI (n = 205) automatically inserted the needle, delivered 5 mL ± 5% in 5.42 minutes (SD 0.74) and retracted. Depots were entirely (93.2%) or predominantly (5.4%) localized within the target subcutaneous tissue. Slight to moderate wheals (63.9%) and erythema (75.1%) were observed with ≥ 50% resolution within 30–60 minutes. Subject pain (100 mm Visual Analog Scale) peaked mid‐injection (mean 9.1 mm, SD 13.4) and rapidly resolved within 30 minutes (mean 0.4 mm, SD 2.6). Subjects’ peak pain (≥ 90.2%), injection site appearance (≥ 92.2%) and injector wear, size, and removal (≥ 92.1%) were acceptable (Likert responses) with 100% likely to use the injector if prescribed. Injection site preference was divided between none (46%), abdomen (25%), or thigh (26.9%). The investigational WI successfully delivered 5 mL viscous subcutaneous injections. Tissue effects and pain were transient, well‐tolerated and acceptable. Neither injection site, movement or subject age affected injector functional performance or subject pain and acceptability.
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spelling pubmed-82127602021-06-25 Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects Woodley, Wendy D. Yue, Wen Morel, Didier R. Lainesse, Audrey Pettis, Ronald J. Bolick, Natasha G. Clin Transl Sci Research An investigational wearable injector (WI), the BD Libertas Wearable Injector (BD Libertas is a trademark of Becton, Dickinson and Company), was evaluated in an early feasibility clinical study for functional performance, tissue effects, subject tolerability, and acceptability of 5 mL, non‐Newtonian ~ 8 cP subcutaneous placebo injections in 52 healthy adult subjects of 2 age groups (18–64 years and ≥ 65 years). Randomized WI subcutaneous injections (n = 208, 4/subject) were delivered to the right and left abdomen and thigh of each subject, 50% (1 thigh and 1 abdomen) with a defined movement sequence during injection. Injector functional performance was documented. Deposition was qualified and quantified with ultrasound. Tissue effects and tolerability (pain) were monitored through 24 hours with corresponding acceptability questionnaires administered through 72 hours. WI (n = 205) automatically inserted the needle, delivered 5 mL ± 5% in 5.42 minutes (SD 0.74) and retracted. Depots were entirely (93.2%) or predominantly (5.4%) localized within the target subcutaneous tissue. Slight to moderate wheals (63.9%) and erythema (75.1%) were observed with ≥ 50% resolution within 30–60 minutes. Subject pain (100 mm Visual Analog Scale) peaked mid‐injection (mean 9.1 mm, SD 13.4) and rapidly resolved within 30 minutes (mean 0.4 mm, SD 2.6). Subjects’ peak pain (≥ 90.2%), injection site appearance (≥ 92.2%) and injector wear, size, and removal (≥ 92.1%) were acceptable (Likert responses) with 100% likely to use the injector if prescribed. Injection site preference was divided between none (46%), abdomen (25%), or thigh (26.9%). The investigational WI successfully delivered 5 mL viscous subcutaneous injections. Tissue effects and pain were transient, well‐tolerated and acceptable. Neither injection site, movement or subject age affected injector functional performance or subject pain and acceptability. John Wiley and Sons Inc. 2021-03-25 2021-05 /pmc/articles/PMC8212760/ /pubmed/33278331 http://dx.doi.org/10.1111/cts.12946 Text en © 2021 Becton Dickinson and Company. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Research
Woodley, Wendy D.
Yue, Wen
Morel, Didier R.
Lainesse, Audrey
Pettis, Ronald J.
Bolick, Natasha G.
Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects
title Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects
title_full Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects
title_fullStr Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects
title_full_unstemmed Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects
title_short Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects
title_sort clinical evaluation of an investigational 5 ml wearable injector in healthy human subjects
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8212760/
https://www.ncbi.nlm.nih.gov/pubmed/33278331
http://dx.doi.org/10.1111/cts.12946
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