A Device Study in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04848402
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
2.7
Anticipated Duration (Months)
22.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: On-Body Delivery System (OBDS)/Multiple Bolus Injector
  • Device: Single Auto Injector
  • Drug: Placebo
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Sep 27, 2021
Anticipated Primary Completion Date :
Dec 17, 2021
Anticipated Study Completion Date :
Dec 17, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: On-Body Delivery System (OBDS)/Multiple Bolus Injector

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

Device: On-Body Delivery System (OBDS)/Multiple Bolus Injector
Used to administer placebo SC.

Drug: Placebo
Administered SC.

Experimental: Single Auto Injector

Single auto injector used to administer placebo SC.

Device: Single Auto Injector
Used to administer placebo SC.

Drug: Placebo
Administered SC.

Outcome Measures

Primary Outcome Measures

  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 [Baseline through day 7]

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1LABCORPLeedsUnited KingdomLS2 9LH

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04848402
Other Study ID Numbers:
  • 17770
  • H7K-MC-O005
First Posted:
Apr 19, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 7, 2021