Clinical Trial

A Study on TLC590 for Managing Postsurgical Pain

Recruiting Phase 2
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Record status
This record was last updated December 2, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-08-25; most recent amendment 2025-11-24.
Status change: Not Yet Recruiting → Recruiting 2024-09-18
Trial Details
NCT Number NCT06574269
Lead Sponsor TLC Biopharmaceuticals, Inc.
Conditions Postsurgical Pain Management
Enrollment 120 participants
Start Date 2024-09-30
Primary Completion 2026-07 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2025-12-02