NCT06574269 · Taiwan Liposome Company
A Study on TLC590 for Managing Postsurgical Pain
What this study is about
This Phase 2 where both patients and doctors know the treatment given trial investigates the how the drug moves through the body (PK), how the drug affects the body, 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).
View original scientific description
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.
Interventions
DRUG
TLC590
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
DRUG
TLC590
TLC590 Dose 1
DRUG
TLC590
TLC590 Dose 2
DRUG
TLC590
The MTD of TLC590
DRUG
TLC590
TLC590 Dose 3 (The SMC-suggested dose)
DRUG
Ropivacaine
Ropivacaine
DRUG
TLC590
TLC590
Primary outcome measures
To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2)
Time frame: 0-168 hours
To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2)
Time frame: 30 days
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- BMI \>18 \~ ≤39 kg/m2
Exclusion criteria
- 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
- Is taking daily analgesics for longer than 4 days per week for a chronically painful condition during the Screening period. Not exclusionary if it is utilized for pain related to the total knee arthroplasty indication
- Is receiving oxygen therapy during the Screening period
- Use of any of the following medications within 5 half-lives prior to the study surgical procedure or as specified
- Malignancy in the last 2 years prior to Screening, 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
- Bellaire, Texas
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 2, 2025 · Source of record for eligibility and locations