Clinical Trial

Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy

Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07574385
Lead Sponsor Rebel Medicine Inc
Conditions Hallux Valgus, Bunionectomy
Enrollment 60 participants
Start Date 2026-03-10
Primary Completion 2026-08 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-07