A Study on TLC590 for Managing Postsurgical Pain

Recruiting now · Phase 2

Conditions studied: Postsurgical Pain Management

In brief

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.

Key facts

Study ID: NCT06574269
Run by: TLC Biopharmaceuticals, Inc.
People needed: 120
Starts: 2024-09-30
Expected to finish: 2026-08-01
Last updated by the study team: 2025-12-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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
BMI >18 \~ ≤39 kg/m2

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
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 it is running

First Surgical Hospital — Bellaire, Texas, United States (enrolling)
Memorial Hermann Village — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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