NCT06574269

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: TLC Biopharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Postsurgical Pain Management

Interventions

Type	Name	Description
DRUG	TLC590	Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
DRUG	TLC590	TLC590 Dose 1
DRUG	TLC590	TLC590 Dose 2
DRUG	TLC590	The MTD of TLC590
DRUG	TLC590	TLC590 Dose 3 (The SMC-suggested dose)
DRUG	Ropivacaine	Ropivacaine
DRUG	TLC590	TLC590

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2024-08-27
• Last updated: 2025-12-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study