Clinical trial NCT04848402: A Device Study in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline through day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: LABCORP
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: