The primary aim of this Phase 1 study is to evaluate the systemic safety of a novel
prolonged-duration local anesthetic, Neosaxitoxin (NeoSTX), given by subcutaneous injection
in combination with the commonly used local anesthetic, bupivacaine, and epinephrine.
The investigators hypothesize that a "minimal adverse effect threshold" NeoSTX dose for
subcutaneous administration in combination with bupivacaine 0.2% and epinephrine 5mcg/ml
respectively, can be defined for awake, young adult healthy volunteer subjects. At the same
time, the pharmacokinetics of NeoSTX when delivered subcutaneously will be determined.
Phase:
Phase 1
Details
Lead Sponsor:
Charles Berde
Treatments:
Anesthetics Anesthetics, Local Bupivacaine Epinephrine Epinephryl borate Neosaxitoxin Racepinephrine