A Phase 3 Study on TLC590 for Managing Postsurgical Pain Following Bunionectomy

Not Applicable

Not yet recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: TLC590; Drug: Bupivacaine; Drug: Saline Placebo

• Registration Number: NCT07222748
• Lead Sponsor: TLC Biopharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-28
• Study First Submitted QC: 2025-10-28
• Last Update Submitted: 2025-10-28
• Study First Posted: 2025-10-30
• Last Update Posted: 2025-10-30
• Study Start: 2025-11-01
• Primary Completion: 2026-04
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TLC590	TLC590	-
Bupivacaine	Bupivacaine	-
Saline Placebo	Saline Placebo	-

Primary Outcome Measures

Name	Time	Method
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.	72 hours

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who are opioid-free for TLC590 compared with Saline Placebo.	72 hours
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.	72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Saline Placebo	72 hours
Proportion of subjects who are opioid-free for TLC590 compared with Bupivacaine Liposome.	72 hours
Mean Total Postoperative Opioid Consumption for TLC590 Compared with Bupivacaine Liposome.	72 hours

Trial Locations

Locations (2)

First Surgical Hospital; 🇺🇸 Bellaire, Texas, United States

Memorial Hermann Village; 🇺🇸 Houston, Texas, United States