Postsurgical Pain ManagementPhase 2NCT06574269
A Study on TLC590 for Managing Postsurgical Pain
A Phase 2 study testing TLC590 and Ropivacaine in people with Postsurgical Pain Management, run by TLC Biopharmaceuticals, Inc. at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postsurgical Pain Management
- What is being tested?
- TLC590 and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2024to Aug 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
First Surgical Hospital
Bellaire, Texas, 77401
- Recruiting
Memorial Hermann Village
Houston, Texas, 77043
About this study
Official title: 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.
Read the 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.
- Conditions
- Postsurgical Pain Management
- Being tested
- TLC590, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLC590Drug
Also called TLC590 (Ropivacaine Extended-Release Injectable Suspension)
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
TLC590Drug
Also called TLC590 (Ropivacaine Extended-Release Injectable Suspension)
TLC590 Dose 1
TLC590Drug
Also called TLC590 (Ropivacaine Extended-Release Injectable Suspension)
TLC590 Dose 2
TLC590Drug
Also called TLC590 (Ropivacaine Extended-Release Injectable Suspension)
The MTD of TLC590
TLC590Drug
Also called TLC590 (Ropivacaine Extended-Release Injectable Suspension)
TLC590 Dose 3 (The SMC-suggested dose)
RopivacaineDrug
Also called Ropivacaine HCL Injection
Ropivacaine
TLC590Drug
Also called TLC590 (Ropivacaine Extended-Release Injectable Suspension)
TLC590
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Cohort 1 | Experimental | Bunionectomy: Increasing dose cohorts for TLC590 Receives: Drug: TLC590 |
| Part 1, Cohort 2 | Experimental | Laparoscopy-assisted Open Ventral Hernia: TLC590 Receives: Drug: TLC590 |
| Part 2, Cohort 3 | Experimental | Breast Augmentation: TLC590 or Ropivacaine Receives: Drug: TLC590; Drug: Ropivacaine |
| Part 2, Cohort 4 | Experimental | Breast Augmentation: TLC590 or Ropivacaine Receives: Drug: TLC590; Drug: Ropivacaine |
| Part 2, Cohort 5 | Experimental | Breast Augmentation: TLC590 with the SMC-suggested dose Receives: Drug: TLC590 |
| Part 3, Cohort 6 | Experimental | Laparoscopy-assisted Open Ventral Hernia: The MTD of TLC590 Receives: Drug: TLC590 |
| Part 3, Cohort 7 | Experimental | Total Knee Arthroplasty: The MTD of TLC590 Receives: Drug: TLC590 |
| Part 3, Cohort 8 | Experimental | Abdominoplasty: The MTD of TLC590 Receives: Drug: TLC590 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2)
Measured: 0-168 hours
To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start30 Sep 2024
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postsurgical Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TLC Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tien-Tzu Tai, MD, Study director, Taiwan Liposome Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574269
- Sponsor's protocol ID
- TLC590A2006
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No