A Study of TLC590 for Postsurgical Pain Following Bunionectomy

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Postoperative Pain

In brief

This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.

Key facts

Study ID

NCT07222748

Run by

TLC Biopharmaceuticals, Inc.

People needed

304

Starts

2025-11-17

Expected to finish

2026-07-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to provide written informed consent.
• Male or female aged 18 years or older (inclusive).
• Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia.
• ASA Physical Status Classification of 1 or 2.
• Male subjects must be either biologically or surgically sterile or commit to the use of a reliable method of birth control (must agree to use double-barrier contraception in the event of sexual activity) or be practicing abstinence.
• Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, or committing to the use of a highly effective method of birth control.
• BMI >18 \~ ≤39 kg/m2, with a minimum weight of 50 kg.

You may not qualify if…

• An abnormal clinical laboratory test value.
• Evidence of a clinically significant abnormal 12-lead ECG.
• History of orthostatic hypotension, syncope, or other syncopal attacks.
• History or any clinical manifestation of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other conditions that have been assessed by the Investigator to make the subject unsuitable for participation in the study.
• History of seizures or taking anticonvulsants.
• History of cardiac arrhythmia or taking Class III antiarrhythmic drugs.
• History of sleep apnea or at-home CPAP treatment.
• History of hypersensitivity to ropivacaine, bupivacaine, any other amide-type local anesthetic, or any other trial-required medications.
• History of severe or refractory PONV due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer, deemed clinically significant by the Investigator.
• Any lifetime history of a suicidal attempt or any suicidal behavior.
• History or positive test results of HIV, HCV, or HBV.
• History or current report of substance abuse including illicit drug abuse and/or alcohol abuse.
• Positive results on the urine drug screen or alcohol breath test.
• Pre-existing concurrent acute, or chronic painful restrictive/physical condition that may confound postoperative pain assessments or is expected to require analgesic treatment during the study.
• Has known or suspected daily use of opioids for longer than 4 days per week within 6 months.
• Use of daily analgesics for longer than 4 days per week for a chronically painful condition.
• Is receiving oxygen therapy.
• Use of any of the pre-specified medications prior to the study surgical procedure or as specified.
• Malignancy in the past 2 years, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
• Personal or family history of malignant hyperthermia.

Where it is running

• Clinical Pharmacology of Miami — Miami, Florida, United States
• First Surgical Hospital — Bellaire, Texas, United States
• Memorial Hermann Village — Houston, Texas, United States
• Endeavor Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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