Investigational On-body Injector Clinical Study

NCT05553418 | Completed

• 1 other identifier: PHS-20OBI01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

On-Body Injector

Outcome Measures

Primary Outcomes (2)

• Device Performance - Dose delivery efficiency

  Determined by volume - measured via gravimetric analysis (weighing the device)

  After device removal

• Device Performance

  Change in adhesive pad adherence - device to skin/device to adhesive pad - determined via adherence scales (Score 0 - 4, whereby 0 is full adherence and 4 is reflecting full detachment)

  From device application until 15-minutes after injection

Secondary Outcomes (7)

• Additional OBI performance - Injection signal/indicator performance

  Before, during and after injection for each applied device; up to 28 hours after application

• Additional OBI performance - Catheter condition

  Approximately 15-minutes after device removal

• Participant Pain

  Immediately before device catheter is inserted, after insertion, during wear period, at start of injection, 15 minutes after injection, end of injection and upon removal for each applied device

• Participant Acceptability Questionnaires

  Device acceptability questionnaire will be completed after device catheter is inserted, at 8 hours and 26 hrs after application, during Injection and upon device removal

• Ultrasound Imaging of injection site

  Baseline and immediately after procedure for each applied device

Study Arms (2)

"In-Clinic wear first"

EXPERIMENTAL

Participant will wear the devices first during 27 hr in-clinic wear first followed by injection, then a short-term wear period in-clinic followed by injection, and finally at home for 27 hrs followed by injection.

Device: In-clinic wear first

"Home wear first"

EXPERIMENTAL

Participant will wear the devices at home first with return to clinic for injection, followed by a short-term wear period in-clinic for injection, and finally during a 27hr in-clinic stay for injection

Device: Home wear first

Interventions

In-clinic wear first DEVICE

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

"In-Clinic wear first"

Home wear first DEVICE

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.

"Home wear first"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult participants ≥ 18 years
• BMI ≥18.5 kg/m2
• Participant willing and able to complete all required study procedures and to provide informed consent

You may not qualify if:

• Participant any self-reported existing chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.).
• Participants with treatment interfering with coagulation, platelet function, or pain perception within 12 hrs of in-clinic visit
• Participants with abdominal or arm skin conditions or treatments that may interfere with planned study treatment
• Participants with acute or chronic hepatitis B or C and/or with known history/positive HIV serology.
• Participants who are pregnant, planning to become pregnant, or are breast-feeding.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (1)

Eurofins Optimed

Gières, France

Location

Study Officials

• Yves Donazzolo, MD

  Eurofins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will participate in three (3) study arms, whereby each participant will wear six (6) OBI prototype devices in total: three (3) on the arm and three (3) on the abdomen. A randomization scheme will be provided with the order of study arm + body location (arm/abdomen) + body side (left/right) randomized.

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: September 23, 2022
• Study Start: September 5, 2022
• Primary Completion: February 8, 2023
• Study Completion: February 8, 2023
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)