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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) in a highly vascular surgical model.
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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:
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:
BMI >18 ~ ≤39 kg/m2
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
120 participants in 8 patient groups
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Central trial contact
Grace Tsao
Data sourced from clinicaltrials.gov
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