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Clinical evaluation of large volume subcutaneous injection tissue effects, pain, and acceptability in healthy adults
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.
• 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 Woodley, Staff Scientist II, Translational & Clinical Sciences, BD Technologies and Innovation, USA