A Device Study in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04848402

H7K-MC-O005 (Other Identifier)

17770

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

Drug: Placebo

Single Auto Injector

Experimental group

Description:

Single auto injector used to administer placebo SC.

Treatment:

Device: Single Auto Injector

Drug: Placebo