A Study on TLC590 for Managing Postsurgical Pain
November 24, 2025 updated by: TLC Biopharmaceuticals, Inc.
A Phase 2, Open-label, Dose-escalation Study to Evaluate Pharmacokinetics, Pharmacodynamics, Bioavailability, Safety, and Tolerability of TLC590 in Multiple Surgical Models
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This Phase 2, open-label, multi-center study is a 3-part study to be performed in approximately 120 subjects undergoing multiple surgical procedures receiving TLC590 or ropivacaine injection.
Subjects eligible based on inclusion and exclusion criteria will receive study drug administered via infiltration.
Subjects entering all parts of the study will undergo the consent and screening procedures, eligibility requirements, and PK and safety evaluations during their participation in the study.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jack Chang
- Phone Number: +886-2-26557377
- Email: Jack@tlcbio.com
Study Locations
-
-
Texas
-
Bellaire, Texas, United States, 77401
- Recruiting
- First Surgical Hospital
-
Contact:
- Daneshvari R. Solanki, MD
-
Houston, Texas, United States, 77043
- Recruiting
- Memorial Hermann Village
-
Contact:
- Dominick S. D'Aunno, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Part 1, Cohort 1
Bunionectomy: Increasing dose cohorts for TLC590
|
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
|
Experimental: Part 1, Cohort 2
Laparoscopy-assisted Open Ventral Hernia: TLC590
|
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
|
Experimental: Part 2, Cohort 3
Breast Augmentation: TLC590 or Ropivacaine
|
Ropivacaine
Other Names:
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
|
Experimental: Part 2, Cohort 4
Breast Augmentation: TLC590 or Ropivacaine
|
Ropivacaine
Other Names:
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
|
Experimental: Part 2, Cohort 5
Breast Augmentation: TLC590 with the SMC-suggested dose
|
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
|
Experimental: Part 3, Cohort 6
Laparoscopy-assisted Open Ventral Hernia: The MTD of TLC590
|
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
|
Experimental: Part 3, Cohort 7
Total Knee Arthroplasty: The MTD of TLC590
|
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
|
Experimental: Part 3, Cohort 8
Abdominoplasty: The MTD of TLC590
|
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
Other Names:
TLC590 Dose 1
Other Names:
TLC590 Dose 2
Other Names:
The MTD of TLC590
Other Names:
TLC590 Dose 3 (The SMC-suggested dose)
Other Names:
TLC590
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2)
Time Frame: 0-168 hours
|
0-168 hours
|
|
To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2)
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tien-Tzu Tai, MD, Taiwan Liposome Company
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 30, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
August 25, 2024
First Submitted That Met QC Criteria
August 25, 2024
First Posted (Actual)
August 27, 2024
Study Record Updates
Last Update Posted (Actual)
December 2, 2025
Last Update Submitted That Met QC Criteria
November 24, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLC590A2006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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