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 2. Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled 3. Scheduled to undergo one of the following elective surgeries, with no additional procedures and be able to use the anesthesia regimen: 1. Unilateral first metatarsal bunionectomy (Cohort 1) 2. Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6) 3. Breast augmentation (Cohort 3 through 5) 4. Unilateral total knee arthroplasty (Cohort 7) 5. Abdominoplasty (tummy tuck) (Cohort 8) 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 for the duration of the study and for 30 days after study drug administration 6. Female subjects a
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