Condition: Hallux Valgus · Bunionectomy · Sponsor: Rebel Medicine Inc
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.
This description comes directly from the study's public registry record.
Caleb Lade, MD · 918-808-8399 · caleb.lade@rebelmedicine.com
Always discuss trial participation with your own doctor first.
| CenExel Salt Lake City | Millcreek, Utah, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07574385