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Phase 2Recruiting

A Study on TLC590 for Managing Postsurgical Pain

A Phase 2, Open-label, Dose-escalation Study to Evaluate Pharmacokinetics, Pharmacodynamics, Bioavailability, Safety, and Tolerability of TLC590 in Multiple Surgical Models

Sponsor
TLC Biopharmaceuticals, Inc. (Industry)
Enrollment
120 planned
Conditions
Postsurgical Pain Management
Interventions
TLC590; TLC590; TLC590; TLC590; TLC590; Ropivacaine; TLC590
Ages
adults, older adults
Registry
NCT06574269

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2)
  • To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2)

History

  1. Study completion

  2. Primary completion

  3. Last registry update

  4. Started

  5. Registered