A Device Study in Healthy Participants

A Study to Investigate the Safety and Tolerability of a Wearable On-body Delivery System, and Exploratory Assessment of Participant Response With an Autoinjector, Following Subcutaneous Injections of Placebo in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of two different devices that may be used to inject medication just under the skin. Participants will receive placebo; no active drug will be given. The study will last up to five weeks for each participant, including a one-week overnight stay in the study center.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Device: On-Body Delivery System (OBDS)/Multiple Bolus Injector; Device: Single Auto Injector

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Labcorp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overtly healthy male or female participants as determined by medical history, laboratory tests, physical examination, 12-lead ECGs, and vital signs.
• Body mass index (BMI) within the range of 18 to 32 kilograms per meter squared (kg/m²)
• Female participants must not be pregnant, and must test negative for pregnancy
• Agree to video recording during each administration event using the autoinjector or bolus injector

Exclusion Criteria:

• Have known allergies to any components of the placebo or related compounds, or history of significant atopy, or known allergies or irritation to adhesives (e.g. skin adhesives, band aid)
• Have an abnormal blood pressure as determined by the investigator
• Have a history or presence of a bleeding disorder
• Have a history of any types of neuropathy, radiculopathy, or fibromyalgia that would affect perception in abdominal wall
• Have self-perceived dullness or loss-of-sensation on either side of the body or the abdomen
• Have any condition that could affect pain perception from an injection
• Have tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection-site assessments
• Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the trial
• Are currently using or intend to use painkillers, aspirin, or other nonsteroidal Anti-inflammatory drugs, anticoagulant or antiaggregant drugs, over-the-counter or prescription medication for pain or inflammation
• Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 2 months or 5 half-lives (whichever is longer) should have passed
• Are unwilling to stop alcohol consumption
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Are unwilling to abide by the tobacco restrictions
• Poor peripheral venous access
• Have a pacemaker and/or similar devices/other implantables

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: On-Body Delivery System (OBDS)/Multiple Bolus Injector; On-Body Delivery System (OBDS)/Multiple bolus injector used to administer placebo subcutaneously (SC).	Drug: Placebo; Administered SC.; Device: On-Body Delivery System (OBDS)/Multiple Bolus Injector; Used to administer placebo SC.
Experimental: Single Auto Injector; Single auto injector used to administer placebo SC.	Drug: Placebo; Administered SC.; Device: Single Auto Injector; Used to administer placebo SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Device	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through day 7

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17770; H7K-MC-O005 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No