ALX006 for Bunion Correction

Overseen By Caleb Lade, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rebel Medicine Inc

Must not be taking: Gabapentinoids, SNRIs, Glucocorticoids, Marijuana

Disqualifiers: Addiction history, Severe kidney impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Immediate pre-surgery

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jayant Agarwal, MD

Principal Investigator

Rebel Medicine Inc

Are You a Good Fit for This Trial?

Inclusion Criteria

I am scheduled for a planned bunion surgery.

I am 18 years old or older.

* Body Mass Index (BMI) ≥18 and \<40 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Single-dose ALX006 or MARCAINE administered as ultrasound-guided sciatic nerve block prior to bunionectomy

Immediate pre-surgery

1 visit (in-person)

Post-surgery Monitoring

Monitoring of pain intensity, opioid consumption, and adverse events post-surgery

168 hours (7 days)

Multiple assessments (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ALX006

How Is the Trial Designed?

Group I: ALX006 200 mg Experimental Treatment 2 Interventions

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.

Group II: ALX006 150 mg Experimental Treatment 2 Interventions

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.

Group III: ALX006 100 mg Experimental Treatment 2 Interventions

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.

Group IV: MARCAINE 0.25% Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Rebel Medicine Inc

Lead Sponsor