Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy

Part of paid clinical trials in Millcreek, Utah.

Sponsor
Rebel Medicine Inc
Study ID
NCT07574385
Phase
PHASE2
Status
Recruiting
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Conditions

  • Bunionectomy
  • Hallux Valgus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALX006 (bupivacaine extended-release injection) — DRUG
    ALX006 (50 mg/mL bupivacaine free base)
  • Bupivacaine Hcl 0.25% Inj — DRUG
    Bupivacaine HCl 0.25% plain (2.5 mg/mL)
  • Sciatic Nerve Block — PROCEDURE
    Sciatic nerve block in the popliteal fossa

Study Details

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.

Key Dates

Start date
Mar 10, 2026
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ALX006 100 mg
    Single-dose ALX006 100 mg (50 mg/mL bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.
  • Experimental: ALX006 150 mg
    Single-dose ALX006 150 mg (50 mg/mL bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.
  • Experimental: ALX006 200 mg
    Single-dose ALX006 200 mg (50 mg/mL; bupivacaine free base) administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.
  • Active Comparator: MARCAINE 0.25%
    Single-dose MARCAINE 0.25% (bupivacaine HCl 50 mg; 20 mL), administered as ultrasound-guided sciatic nerve block in the popliteal fossa, 60 min (±15 min) prior to bunionectomy.

Primary Outcome Measure

Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: From start of nerve block procedure through 360 Hour Visit (Day 15) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CenExel Salt Lake CityMillcreekUtah84107
Director of Clinical Operations
[email protected]
(801) 261-2000
Todd Bertoch, MD (PRINCIPAL_INVESTIGATOR)

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CenExel Salt Lake City· Millcreek, UT

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