Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy
Status:
Recruiting
Trial end date:
2021-10-21
Target enrollment:
Participant gender:
Summary
This two-part study will be conducted in male and female patients 18 to 65 years of age
undergoing bunionectomy.
Part I - three-step, single ascending dose study design in which two drug loads (low drug
load of funapide and high drug load of funapide) and two volumes (high volume and low volume)
of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3
placebo) for the management of post-surgical pain in patients undergoing bunionectomy.
Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and
efficacy of a selected drug load/volume of FX301. An additional 36 patients will be
randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic
nerve block adjacent to the sciatic nerve of the popliteal fossa.