Actively Recruiting
A Study on TLC590 for Managing Postsurgical Pain
Led by TLC Biopharmaceuticals, Inc. · Updated on 2025-12-02
120
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study on TLC590 for Managing Postsurgical Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Male or female aged 18 to 70 years, inclusive; for Part 2 breast augmentation surgery, only females are eligible
- Scheduled for one of these elective surgeries without additional procedures: unilateral first metatarsal bunionectomy, laparoscopy-assisted open ventral hernia repair, breast augmentation, unilateral total knee arthroplasty, or abdominoplasty
- ASA Physical Status Classification of 1 or 2
- Male subjects must be sterile or agree to use reliable birth control or abstinence during the study and for 30 days after
- Female subjects must not be pregnant, lactating, or planning pregnancy during the study, and if of childbearing potential, must use highly effective birth control during and for 30 days after the study
- Body mass index between greater than 18 and up to 39 kg/m2
You will not qualify if you...
- Clinically significant abnormal lab test values
- Clinically significant abnormal 12-lead ECG
- History of orthostatic hypotension, syncope, or similar fainting episodes
- History or clinical signs of significant renal, liver, gastrointestinal, heart, metabolic, neurological, psychiatric, or other conditions making participation unsuitable
- History of seizures or use of anticonvulsants during screening
- History of cardiac arrhythmia or use of Class III antiarrhythmic drugs during screening
- History of sleep apnea or use of home CPAP treatment
- Known allergy to ropivacaine, other local anesthetics, propofol, hydromorphone, fentanyl, midazolam, acetaminophen, oxycodone, morphine, or similar opioids
- History of severe or refractory postoperative nausea and vomiting from other causes
- Any history of suicidal behavior
- History or positive test for HIV, hepatitis C, or hepatitis B
- History or current substance abuse, including illicit drugs or alcohol abuse within 2 years prior to screening
- Positive urine drug or alcohol test at screening or before surgery (except prescribed medication)
- Existing acute or chronic painful condition that may interfere with pain assessment or require analgesics during the study
- Daily opioid use more than 4 days per week within 6 months prior to screening
- Daily use of analgesics more than 4 days per week for chronic pain (except for total knee arthroplasty pain)
- Receiving oxygen therapy during screening
- Use of certain medications within 5 half-lives before surgery
- Malignancy within 2 years before screening, except certain skin and cervical cancers
- Personal or family history of malignant hyperthermia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
First Surgical Hospital
Bellaire, Texas, United States, 77401
Actively Recruiting
2
Memorial Hermann Village
Houston, Texas, United States, 77043
Actively Recruiting
Research Team
J
Jack Chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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