Sciatic Nerve Block With ALX006 in Subjects Undergoing Bunionectomy

  • STATUS
    Recruiting
  • End date
    Aug 7, 2026
  • participants needed
    60
  • sponsor
    Rebel Medicine Inc
Send
Updated on 7 May 2026
See if I qualify

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.

Details
Condition Hallux Valgus, Bunionectomy
Age 18years or above
Clinical Study IdentifierNCT07574385
SponsorRebel Medicine Inc
Last Modified on7 May 2026

Eligibility

 Yes No Not Sure

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

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
Currently pregnant, nursing, or planning to become pregnant during the study
Clinically significant medical disease that, in the opinion of the Investigator would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction, glucose-6-phosphate dehydrogenase deficiency or other conditions that would constitute a contraindication to participation in the study
Confirmed clinically significant vital sign or ECG abnormality, including QTcF > 450 msec at Screening
Has any of the following laboratory abnormalities during Screening (1 retest permitted)
History of liver cirrhosis, having an aspartate aminotransferase >3x the upper limit of normal (ULN), or having an alanine aminotransferase > 3x ULN
Severe kidney function impairment as defined by estimated glomerular filtration rate (eGFR) by CKD-EPI 2021 equation <30 mL/min/1.73 m²or on dialysis
Platelet count < 100,000/uL, hemoglobin < 12 g/dL, or hematocrit < 35%
Currently on a gabapentinoid (e.g., gabapentin, pregabalin [Lyrica]) or a serotonin-norepinephrine reuptake inhibitor (SNRI) with recognized analgesic properties (e.g., duloxetine [Cymbalta]) that cannot be discontinued within 30 days before surgery. Other agents with documented efficacy in modulating acute or chronic pain may be excluded at the discretion of the Investigator in consultation with the Sponsor Medical Monitor. Selective serotonin reuptake inhibitors (SSRIs) are not excluded under this criterion
Current use of systemic glucocorticoids within thirty (30) days of randomization in this study
Use of dexmedetomidine HCl or clonidine within three (3) days of study drug administration
Any use of marijuana (including tetrahydrocannabinol (THC) and cannabidiol (CBD)) within thirty (30) days prior to randomization, or planned use during the study
Chronic opioid use within thirty (30) days prior to randomization (average ≥30 oral morphine mg equivalents/day)
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
0 0 /250
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.