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Investigational On-body Injector Clinical Study

NCT05553418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.

Conditions

  • Healthy Volunteers

Interventions

DEVICE

In-clinic wear first

Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection

DEVICE

Home wear first

Device will be applied to the abdomen or arm to deliver placebo subcutaneously. After device application, participant will go home and return to clinic before delivery.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Yves Donazzolo, MD · Eurofins

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2023-02-08
Completion
2023-02-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553418 on ClinicalTrials.gov