A Study of TLC590 for Postsurgical Pain Following Bunionectomy

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified October 2025 by TLC Biopharmaceuticals, Inc.
Sponsor
TLC Biopharmaceuticals, Inc.
Information Provided by (Responsible Party)
TLC Biopharmaceuticals, Inc.
Clinicaltrials.gov Identifier
NCT07222748
Other Study ID Numbers:
TLC590A3004
First Submitted
October 27, 2025
First Posted
October 29, 2025
Last Update Posted
December 1, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Postoperative Pain
Drug: TLC590Drug: Liposomal BupivacaineDrug: Saline Placebo

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-blind, Comparator- and Placebo-controlled Study to Evaluate the Safety and Efficacy of TLC590 for Postsurgical Pain Management Following Bunionectomy
Study Start DateNovember 16, 2025
Actual Primary Completion DateMarch 31, 2026
Actual Study Completion DateApril 30, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
TLC590
Drug: TLC590
TLC590 (Ropivacaine Extended-Release Injectable Suspension)
Liposomal Bupivacaine
Drug: Liposomal Bupivacaine
Bupivacaine Liposome Injectable Suspension
Saline Placebo
Drug: Saline Placebo
Normal Saline 0.9%

Outcome Measures

Primary Outcome Measures
  1. Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Saline Placebo.
    Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.
Secondary Outcome Measures
  1. Proportion of subjects who are opioid-free for TLC590 compared with Saline Placebo.
  2. Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores Through 72 Hours Postsurgery (AUC0-72), Compared with Bupivacaine Liposome.
    Pain intensity is measured using an 11-point Numeric Rating Scale (NRS) (0-10), where 0 represents "no pain" and 10 represents "worst pain imaginable", and higher scores indicate worse pain.
  3. Mean Total Postoperative Opioid Consumption for TLC590 Compared with Saline Placebo
  4. Proportion of subjects who are opioid-free for TLC590 compared with Bupivacaine Liposome.
  5. Mean Total Postoperative Opioid Consumption for TLC590 Compared with Bupivacaine Liposome.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Able and willing to provide written informed consent. 2. Male or female aged 18 years or older (inclusive). 3. Scheduled to undergo a primary unilateral, transpositional first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia. 4. ASA Physical Status Classification of 1 or 2. 5. 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. 6. 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. 7. BMI \>18 \~ ≤39 kg/m2, with a minimum weight of 50 kg.
Exclusion Criteria
1. An abnormal clinical laboratory test value. 2. Evidence of a clinically significant abnormal 12-lead ECG. 3. History of orthostatic hypotension, syncope, or other syncopal attacks. 4. 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. 5. History of seizures or taking anticonvulsants. 6. History of cardiac arrhythmia or taking Class III antiarrhythmic drugs. 7. History of sleep apnea or at-home CPAP treatment. 8. History of hypersensitivity to ropivacaine, bupivacaine, any other amide-type local anesthetic, or any other trial-required medications. 9. 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. 10. Any lifetime history of a suicidal attempt or any suicidal behavior. 11. History or positive test results of HIV, HCV, or HBV. 12. History or current report of substance abuse including illicit drug abuse and/or alcohol abuse. 13. Positive results on the urine drug screen or alcohol breath test. 14. 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. 15. Has known or suspected daily use of opioids for longer than 4 days per week within 6 months. 16. Use of daily analgesics for longer than 4 days per week for a chronically painful condition. 17. Is receiving oxygen therapy. 18. Use of any of the pre-specified medications prior to the study surgical procedure or as specified. 19. 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. 20. Personal or family history of malignant hyperthermia.

Contacts and Locations

Sponsors and CollaboratorsTLC Biopharmaceuticals, Inc.
Locations
Clinical Pharmacology of Miami | Miami Florida, United States, 33172First Surgical Hospital | Bellaire Texas, United States, 77401Memorial Hermann Village | Houston Texas, United States, 77043Endeavor Clinical Trials | San Antonio Texas, United States, 78240
Investigators
Study Director: Tien-Tzu Tai, MD, Taiwan Liposome Company