A Device Study in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848402
• Other study ID #: 17770
• Secondary ID: H7K-MC-O005
• Status: Completed
• Phase: Phase 1
• Start date: September 27, 2021
• Est. completion date: July 22, 2022

Study information

• Verified date: February 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 22, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• On-Body Delivery System (OBDS)/Multiple Bolus Injector
Used to administer placebo SC.
• Single Auto Injector
Used to administer placebo SC.

Drug:
• Placebo
Administered SC.

Locations

Country	Name	City	State
United Kingdom	LABCORP	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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