A Device Study in Healthy Participants

NCT ID: NCT04848402

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2022-07-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Used to administer placebo SC.

Placebo

Intervention Type: DRUG

Administered SC.

Single Auto Injector

Single auto injector used to administer placebo SC.

Group Type: EXPERIMENTAL

Single Auto Injector

Intervention Type: DEVICE

Used to administer placebo SC.

Placebo

Intervention Type: DRUG

Administered SC.

Interventions

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

Used to administer placebo SC.

Intervention Type: DEVICE

Single Auto Injector

Used to administer placebo SC.

Intervention Type: DEVICE

Placebo

Administered SC.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

LABCORP

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

H7K-MC-O005

Identifier Type: OTHER

Identifier Source: secondary_id

17770

Identifier Type: -

Identifier Source: org_study_id