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Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy

NCT07574385 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Hallux Valgus
  • Bunionectomy

Interventions

DRUG

ALX006 (bupivacaine extended-release injection)

ALX006 (50 mg/mL bupivacaine free base)

DRUG

Bupivacaine Hcl 0.25% Inj

Bupivacaine HCl 0.25% plain (2.5 mg/mL)

PROCEDURE

Sciatic Nerve Block

Sciatic nerve block in the popliteal fossa

Sponsors & Collaborators

  • Rebel Medicine Inc

    lead INDUSTRY

Principal Investigators

  • Jayant Agarwal, MD · Rebel Medicine Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574385 on ClinicalTrials.gov