A Device Study in Healthy Participants

NCT04848402 | Completed Phase 1

• 2 other identifiers: 17770H7K-MC-O005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

On-Body Delivery System (OBDS)/Multiple Bolus Injector

EXPERIMENTAL

On-Body Delivery System (OBDS)/Multiple bolus injector used to administer placebo subcutaneously (SC).

Device: On-Body Delivery System (OBDS)/Multiple Bolus Injector; Drug: Placebo

Single Auto Injector

EXPERIMENTAL

Single auto injector used to administer placebo SC.

Device: Single Auto Injector; Drug: Placebo

Interventions

On-Body Delivery System (OBDS)/Multiple Bolus Injector DEVICE

Used to administer placebo SC.

On-Body Delivery System (OBDS)/Multiple Bolus Injector

Single Auto Injector DEVICE

Used to administer placebo SC.

Single Auto Injector

Placebo DRUG

Administered SC.

On-Body Delivery System (OBDS)/Multiple Bolus Injector; Single Auto Injector

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

LABCORP

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 19, 2021
• Study Start: September 27, 2021
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)