BunionectomyPhase 2NCT07858734
Postsurgical Analgesia After Unilateral Bunionectomy
A Phase 2 study testing AMT-143 in people with Bunionectomy and Bunion, run by AmacaThera Inc..
Trial summary
The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bunionectomy, Bunion
- What is being tested?
- AMT-143
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 15 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to provide written informed consent, adhere to the study visit schedule, and complete all study assessments.
- Adults 18 to 75 years at screening.
- Planned distal metaphyseal osteotomy procedure (e.g., Austin procedure/chevron osteotomy) under general anesthesia.
- Health surgery rating according to American Society of Anesthesiologists (ASA) class 1-3.
- Body mass index (BMI) ≥18 and ≤39 kg/m^2.
Who cannot join
- Surgery is for minimally invasive bunionectomy procedure.
- Contralateral bunionectomy within 3 months of study dosing.
- Planned surgical intervention concurrent with unilateral bunionectomy (e.g., collateral procedures).
- Hypersensitivity/allergy to any ingredient in AMT-143 formulation (hyaluronan or methylcellulose).
- History or presence of glucose-6-phosphate dehydrogenase deficiency.
- History or presence of congenital or idiopathic methemoglobinemia.
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- Hypersensitivity/allergy to amide type local anaesthetics (e.g., lidocaine, bupivacaine, ropivacaine, etc.).
- Loss of sensation or significant peripheral neuropathy on the side of bunionectomy.
- Concurrent pain syndromes (e.g., arthritis, fibromyalgia, cancer, etc.) that would require an additional use of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or opioids during the course of the study.
- Arrhythmias predisposing to long QT syndrome (e.g., ventricular tachycardia, atrial fibrillation, atrioventricular block, etc.).
- Disease or condition that in the opinion of the Investigator, would pose a health risk to the participant or interfere with study assessments or compliance, including but not limited to, any of the following:
- Myocardial infarction within 6 months of study dosing or coronary bypass grafting within 12 months of study dosing.
- Congestive heart failure (New York Heart Association Class III-IV).
- Uncontrolled diabetes with A1C hemoglobin ≥ 7%.
- Severe peripheral vascular disease.
- Pulmonary dysfunction.
- Severe hepatic or renal dysfunction.
- Coagulation or bleeding disorders.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorders.
- Have history of human immunodeficiency virus (HIV) or hepatitis B/hepatitis C or a positive test at screening.
- Suspected or known addiction or abuse of illicit drugs, prescription medications, or alcohol within 2 years of study.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study dosing, or planned administration of another investigational drug or procedure during the subject's participation in this study.
- Administration of medications with a potential for drug interactions with ropivacaine (i.e., amide-type local anaesthetics such as lidocaine, bupivacaine, mepivacaine and prilocaine; antiarrhythmics such as procainamide, disopyramide, tocainide, mexiletine and flecainide; inhibitors of cytochrome P4501A2 such as fluvoxamine and enoxacin) for at least 5 half-lives prior to study dosing.
- Current use of neuromodulating agents [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta), etc.].
- Use of systemic glucocorticoids within 30 days of study dosing.
- Use of dexmedetomidine HCl (Precedex®) or clonidine within 3 days of study dosing.
- Chronic opioid use [average ≥30 oral morphine equivalents (OMEDs)/day] within 30 days of study dosing.
- Use of opioid medications within 3 days of study dosing.
- Use of marijuana, tetrahydrocannabinol (THC), and cannabidiol (CBD) within 30 days of study dosing or planned use during the course of the study.
- Current pregnancy, nursing, or planning to become pregnant during the study.
- Unwillingness to use effective methods of contraception during participation in this study (for females with childbearing potential and males).
- Recent or potential exposure to COVID-19.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of AMT-143 for Postsurgical Analgesia After Unilateral Bunionectomy
The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.
- Conditions
- Bunionectomy, Bunion
- Being tested
- AMT-143, Saline (NaCl 0,9 %) (placebo)
- Medical subject headings
- Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-143Drug
Group 1 will receive AMT-143 containing 354 mg ropivacaine.
AMT-143Drug
Group 2 will receive AMT-143 containing 707 mg ropivacaine.
Saline (NaCl 0,9 %) (placebo)Other
Group 3 will receive 2.00 mL Placebo [sodium chloride (NaCl) 0.9%].
| Study group | Role | What they receive |
|---|---|---|
| AMT-143 Group 1 | Experimental | Not described Receives: Drug: AMT-143 |
| AMT-143 Group 2 | Experimental | Not described Receives: Drug: AMT-143 |
| Saline Placebo | Placebo comparator | Not described Receives: Other: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of AMT-143
To evaluate the safety and tolerability of AMT-143 in participants undergoing unilateral bunionectomy.
The primary safety endpoint is the incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) which reflect manifestations of local anesthetic (ropivacaine) systemic toxicity (LAST).
Measured: From surgery to Day 28 follow-up
Secondary outcomes (7)
Analgesic Efficacy of AMT-143
To evaluate efficacy of AMT-143 for postsurgical pain management following unilateral bunionectomy.
Numeric Rating Scale (NRS) pain intensity will be assessed while the participant is seated/recumbent with the surgically attended leg elevated or lying supine. The participant will be asked to rate their pain intensity on a scale of 0 to 10, where 0 = no pain and 10 = worst pain.
Measured: From surgery to Day 28 follow-up
Area under the plasma concentration-versus-time curve (AUC)
Measured: From surgery to Day 28 follow-up
Maximum observed plasma concentration (Cmax)
Measured: From surgery to Day 28 follow-up
Time of maximum observed plasma concentration (Tmax)
Measured: From surgery to Day 28 follow-up
Apparent terminal elimination half-life (t1/2)
Measured: From surgery to Day 28 follow-up
Apparent clearance (CL)
Measured: From surgery to Day 28 follow-up
Apparent volume of distribution (Vd)
Measured: From surgery to Day 28 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BunionectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AmacaThera Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858734
- Sponsor's protocol ID
- AMT-143-004
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of AMT-143 for Postsurgical Analgesia After Unilateral Bunionectomy
- ClinicalTrials.gov ID
- NCT07858734
- Acronym / sponsor ID
- AMT-143-004
- Conditions
- Bunionectomy, Bunion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AmacaThera Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMT-143 Group 1 | Experimental | Drug: AMT-143 |
| AMT-143 Group 2 | Experimental | Drug: AMT-143 |
| Saline Placebo | Placebo comparator | Other: Saline (NaCl 0,9 %) (placebo) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability and willingness to provide written informed consent, adhere to the study visit schedule, and complete all study assessments.
- Adults 18 to 75 years at screening.
- Planned distal metaphyseal osteotomy procedure (e.g., Austin procedure/chevron osteotomy) under general anesthesia.
- Health surgery rating according to American Society of Anesthesiologists (ASA) class 1-3.
- Body mass index (BMI) ≥18 and ≤39 kg/m^2.
Key exclusion criteria (32 listed)
- Surgery is for minimally invasive bunionectomy procedure.
- Contralateral bunionectomy within 3 months of study dosing.
- Planned surgical intervention concurrent with unilateral bunionectomy (e.g., collateral procedures).
- Hypersensitivity/allergy to any ingredient in AMT-143 formulation (hyaluronan or methylcellulose).
- History or presence of glucose-6-phosphate dehydrogenase deficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMT-143Group 1 will receive AMT-143 containing 354 mg ropivacaine. | Drug | AMT-143 Group 1 |
| AMT-143Group 2 will receive AMT-143 containing 707 mg ropivacaine. | Drug | AMT-143 Group 2 |
| Saline (NaCl 0,9 %) (placebo)Group 3 will receive 2.00 mL Placebo [sodium chloride (NaCl) 0.9%]. | Other | Saline Placebo |
Primary outcome
Safety and Tolerability of AMT-143
Time frame: From surgery to Day 28 follow-up
To evaluate the safety and tolerability of AMT-143 in participants undergoing unilateral bunionectomy. The primary safety endpoint is the incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) which reflect manifestations of local anesthetic (ropivacaine) systemic toxicity (LAST).
7 secondary outcomes
Analgesic Efficacy of AMT-143
Time frame: From surgery to Day 28 follow-up
Area under the plasma concentration-versus-time curve (AUC)
Time frame: From surgery to Day 28 follow-up
Maximum observed plasma concentration (Cmax)
Time frame: From surgery to Day 28 follow-up
Time of maximum observed plasma concentration (Tmax)
Time frame: From surgery to Day 28 follow-up
Apparent terminal elimination half-life (t1/2)
Time frame: From surgery to Day 28 follow-up
Apparent clearance (CL)
Time frame: From surgery to Day 28 follow-up
Apparent volume of distribution (Vd)
Time frame: From surgery to Day 28 follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMT-143 in people with Bunionectomy and Bunion, run by AmacaThera Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ab Khulbe (416-360-2094, ab@amacathera.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of AMT-143 (time frame: From surgery to Day 28 follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.