A Phase 2, Open-label, Dose-escalation Study to Evaluate Pharmacokinetics, Pharmacodynamics, Bioavailability, Safety, and Tolerability of TLC590 in Multiple Surgical Models
TLC Biopharmaceuticals, Inc.
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). 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.
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.
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able and willing to provide written informed consent 2. Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled 3. Scheduled to undergo one of the following elective surgeries, with no additional procedures and be able to use the anesthesia regimen: 1. Unilateral first metatarsal bunionectomy (Cohort 1) 2. Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6) 3. Breast augmentation (Cohort 3 through 5) 4. Unilateral total knee arthroplasty (Cohort 7) 5. Abdominoplasty (tumm…
Interventions
- DrugTLC590
Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
- DrugTLC590
TLC590 Dose 1
- DrugTLC590
TLC590 Dose 2
- DrugTLC590
The MTD of TLC590
- DrugTLC590
TLC590 Dose 3 (The SMC-suggested dose)
- DrugRopivacaine
Ropivacaine
- DrugTLC590
TLC590
Locations (2)
- First Surgical HospitalBellaire, Texas
- Memorial Hermann VillageHouston, Texas