A Study on TLC590 for Managing Postsurgical Pain

NCT06574269 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TLC590A2006
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase 2 open-label trial investigates the pharmacokinetics (PK), pharmacodynamics, and safety profile of TLC590 across various surgical procedures. Researchers aim to determine the maximum tolerated dose (MTD) of TLC590 via Safety Monitoring Committee (SMC). The study evaluates TLC590 in bunionectomy, laparoscopy-assisted open ventral hernia repair, breast augmentation, abdominoplasty, and total knee arthroplasty models. Additionally, it determines the relative bioavailability of TLC590 to ropivacaine injection.

Conditions

Postsurgical Pain Management

Outcome Measures

Primary Outcomes (2)

• To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2)

  0-168 hours

• To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2)

  30 days

Study Arms (8)

Part 1, Cohort 1

EXPERIMENTAL

Bunionectomy: Increasing dose cohorts for TLC590

Drug: TLC590

Part 1, Cohort 2

EXPERIMENTAL

Laparoscopy-assisted Open Ventral Hernia: TLC590

Drug: TLC590

Part 2, Cohort 3

EXPERIMENTAL

Breast Augmentation: TLC590 or Ropivacaine

Drug: TLC590; Drug: Ropivacaine

Part 2, Cohort 4

EXPERIMENTAL

Breast Augmentation: TLC590 or Ropivacaine

Drug: TLC590; Drug: Ropivacaine

Part 2, Cohort 5

EXPERIMENTAL

Breast Augmentation: TLC590 with the SMC-suggested dose

Drug: TLC590

Part 3, Cohort 6

EXPERIMENTAL

Laparoscopy-assisted Open Ventral Hernia: The MTD of TLC590

Drug: TLC590

Part 3, Cohort 7

EXPERIMENTAL

Total Knee Arthroplasty: The MTD of TLC590

Drug: TLC590

Part 3, Cohort 8

EXPERIMENTAL

Abdominoplasty: The MTD of TLC590

Drug: TLC590

Interventions

TLC590 DRUG

Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590

Also known as: TLC590 (Ropivacaine Extended-Release Injectable Suspension)

Part 1, Cohort 1

Ropivacaine DRUG

Ropivacaine

Also known as: Ropivacaine HCL Injection

Part 2, Cohort 3; Part 2, Cohort 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent
• Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled
• Scheduled to undergo one of the following elective surgeries, with no additional procedures and be able to use the anesthesia regimen:
• Unilateral first metatarsal bunionectomy (Cohort 1)
• Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6)
• Breast augmentation (Cohort 3 through 5)
• Unilateral total knee arthroplasty (Cohort 7)
• Abdominoplasty (tummy tuck) (Cohort 8)
• 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 for the duration of the study and for 30 days after study drug administration
• Female subjects are eligible only if all the following apply:
• Not pregnant with a negative serum pregnancy test at Screening and negative urine pregnancy test on Day 1 before surgery (pregnancy test not required for females of non-childbearing potential, defined as surgically sterile or post-menopausal)
• Not lactating
• Not planning to become pregnant during the study
• If of childbearing potential, commits to the use of a highly effective method of birth control for the duration of the study and or at least 30 days after study drug administration

You may not qualify if:

• A clinically significant abnormal clinical laboratory test value
• Evidence of a clinically significant 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 condition that has been assessed by the Investigator to be unsuitable for participation in the study
• History of seizures or taking anticonvulsants during the Screening period
• History of cardiac arrhythmia or taking Class III antiarrhythmic drugs including amiodarone, dofetilide, dronedarone, sotalol, or ibutilide during the Screening period
• History of sleep apnea or on home CPAP treatment
• History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, hydromorphone, fentanyl, midazolam, acetaminophen, oxycodone, or morphine (or other opioids)
• 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, as assessed by the C-SSRS at Screening
• 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 (regularly drinks \>4 units of alcohol per day: 1 unit = 8 oz. beer, 3 oz. wine, or 1 oz. spirits) within 2 years prior to Screening
• Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or non-prescribed drug or alcohol abuse at Screening or on Day 1 before surgery. Prescribed medication that is known to result in a positive drug test is allowed. Marijuana (medical or recreational) is not allowed
• 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 the previous 6 months prior to Screening

Sponsors & Collaborators

• TLC Biopharmaceuticals, Inc.: lead

Study Sites (2)

First Surgical Hospital

Bellaire, Texas, 77401, United States

RECRUITING

Memorial Hermann Village

Houston, Texas, 77043, United States

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Tien-Tzu Tai, MD

  Taiwan Liposome Company

  STUDY DIRECTOR

Central Study Contacts

Jack Chang

CONTACT

+886-2-26557377; Jack@tlcbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 27, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

US (2)