Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT04848402
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04848402
Study Brief:
Protocol Section:
NCT04848402