Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
A Phase 2, Randomized, Double-blind, Active-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of ALX006 for Postsurgical Pain Management When Administered as a Sciatic (in the Popliteal Fossa) Nerve Block in Subjects Undergoing a Bunionectomy
Rebel Medicine Inc
60 participants
Mar 10, 2026
INTERVENTIONAL
Conditions
Summary
This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as a single-dose sciatic nerve block in the popliteal fossa in adult subjects undergoing primary unilateral bunionectomy. Approximately 60 subjects will be enrolled across 3 sequential dose cohorts (100 mg, 150 mg, 200 mg ALX006), with each cohort comparing ALX006 against MARCAINE 0.25% (bupivacaine HCl 50 mg) as the active comparator at a 3:1 randomization ratio. Dose escalation between cohorts is governed by an Independent Data Monitoring Committee.
Eligibility
Plain Language Summary
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Interventions
ALX006 (50 mg/mL bupivacaine free base)
Bupivacaine HCl 0.25% plain (2.5 mg/mL)
Sciatic nerve block in the popliteal fossa
Locations(1)
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NCT07574385