Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Rebel Medicine Inc
You may qualify if…
- ✓ Male or female, ages 18 or older at screening
- ✓ American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 5)
- ✓ Able to provide informed consent, adhere to the study schedule, and complete all study assessments
- ✓ Primary surgical indication is related to a bunion deformity (i.e., hallux valgus) and subject is scheduled to undergo a primary unilateral distal metaphyseal osteotomy procedure (i.e., Austin procedure)
- ✓ Indicated to undergo elective (i.e., not emergency) bunionectomy
- ✓ Body Mass Index (BMI) ≥18 and \<40 kg/m2
You may not qualify if…
- ✕ Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
- ✕ Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the surgery and which, in the Investigator's opinion, may confound the post dosing assessments
- ✕ Inadequate sensory function of the foot/ankle as assessed by the Investigator
- ✕ History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two (2) years
- ✕ Administration of an investigational drug within thirty (30) days or five (5) elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
- ✕ Administration of any local anesthetic within 72 hours prior to administration of study drug, other than for pretreatment prior to a needle placement
- ✕ Require additional local anesthetic other than study drug or lidocaine used for the Mayo field block or for pretreatment prior to a needle placement during the study period
- ✕ Uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
Where it's recruiting
Millcreek
Source: ClinicalTrials.gov · NCT07574385 · last updated 2026-05-07