I6Q-MC-BIFD SC Injections of Buffer Matrices in Healthy Subjects
Research type
Research Study
Full title
A Randomized Study to Investigate Injection-Site Pain Following Subcutaneous injections of Buffer Matrices in Healthy Subjects
IRAS ID
249207
Contact name
Firas Almazedi
Contact email
Sponsor organisation
Eli Lilly & Company Limited
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
It has been noted on several Lilly studies that one of the main adverse events are injection site pain, with the intensity of this acute pain yet to be investigated using validated pain scales. This study is being conducted to compare acute pain site intensity when different buffer solutions are injected, this information will help Lilly to improve the formulation of their products to help minimise injection site pain.
We will be subcutaneously injecting volunteers with inactive versions of different buffer solutions, the volume will be 1ml and none of the solutions will have any active drugs.
A previous study (BIFC) determined the combination of buffer and tonicity agent determined injection site pain. This study will expand upon this and have a larger number of formulation variables with additional tonicity agents and buffers.
This is a single-site, 2-period, non-active treatment, subject- and investigator-blind, randomized, crossover study in healthy subjects. This study may involve the exposure of up to 10 different buffer conditions to subjects in the form of 1-mL subcutaneous (SC) injections into the abdominal wall. No active investigational product will be administered in this study.
Each subject will be randomized to receive a total of five 1-mL SC injections on Day 1 of each of Periods 1 and 2. The order of the treatments will be randomized in both periods, and there will be an interval of approximately 2 hours between each SC injection. In both periods, subjects will be discharged from the CRU on Day 1 following completion of study procedures, provided they are deemed medically fit by the investigator or designee. There will be at least 7 days between the 2 study periods.
Subjects will receive a follow-up phone call within 14 days following the final SC injection to determine if any later onset injection-site reactions may have occurred. For purposes of this study, a subject completes the study when all scheduled procedures shown in the Trial Schedule have been finished.REC name
HSC REC B
REC reference
18/NI/0135
Date of REC Opinion
17 Jul 2018
REC opinion
Favourable Opinion