A Phase 2, Randomized, Double-blind, Active-controlled, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, Efficacy and Pharmacodynamics of ALX006 for Postsurgical Pain Management When Administered as a Sciatic (in the Popliteal Fossa) Nerve Block in Subjects Undergoing a Bunionectomy
Rebel Medicine Inc
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: *…
Interventions
- DrugALX006 (bupivacaine extended-release injection)
ALX006 (50 mg/mL bupivacaine free base)
- DrugBupivacaine Hcl 0.25% Inj
Bupivacaine HCl 0.25% plain (2.5 mg/mL)
- ProcedureSciatic Nerve Block
Sciatic nerve block in the popliteal fossa
Location
- CenExel Salt Lake CityMillcreek, Utah