A Study to Investigate On-body Device System Safety and Tolerability
Research type
Research Study
Full 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
IRAS ID
292093
Contact name
Samuel Israel
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a large volume injection device feasibility study, being conducted to primarily study the effect of delivery rate and volume on injection safety/tolerability as well as user preference between a single injection via on-body delivery system (OBDS; also referred to as bolus injector) and multiple injections with an autoinjector
This is a single-site, non-active treatment, study in healthy participants.
This study involves five different forms of SC (subcutaneous) placebo injections into the abdomen. Participants will self-inject study intervention under medical supervision. Injections will be rotated among different injection sites on the anterior abdominal wall during the study periods (that is, left/right lower quadrants and left/right upper quadrant).
Each participant will be randomized to receive a single SC administration of the placebo on each of Days 1 to 5. Each administration will differ in terms of volume, delivery speed, and device (ie, bolus injector vs autoinjector). Participants will be randomized to 1 of 5 SC injection sequences.
There will be a washout period of approximately 24 hours between each SC injection.Participants will be discharged from the CRU on Day 6 following the completion of all safety assessments.
Participants will receive a follow up phone call 24 hours after discharge from the CRU to assess adverse events. Based on the responses the participant may have to return to clinic for an in person follow up within the 7 days after the final injection. This determination will be made by the PI in discussion with the clinical pharmacologist.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0070
Date of REC Opinion
30 Jun 2021
REC opinion
Further Information Favourable Opinion