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Clinical evaluation of large volume subcutaneous injection tissue effects, pain, and acceptability in healthy adults

28 April 2022

Early feasibility clinical study was performed to assess the feasibility and tolerability of syringe pump-driven, constant rate (20µl/s), 1-20cP, 5 and 10ml subcutaneous placebo injections to the thigh (5ml only) and abdomen in 32 healthy adults. Endpoints include injection feasibility, depot location, pressure, subject pain tolerability/acceptability and the corresponding tissue effects.

Session Outline:

• Demonstrate the feasibility and broad acceptability of subcutaneous injections up to 10ml and 20cP administered without a permeation enhancer

• Determine if injection site tissue effects are visible and transient as well as the impact of injection site, volume and viscosity on these patterns

• Explore the relationship between subjects’ pain/acceptability and the injection site, volume and/or viscosity



Mathew Cherian, Consultant, Executive Committee Member (IPS), USA


Wendy D WoodleyStaff Scientist II, Translational & Clinical Sciences, BD Technologies and InnovationUSA