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A Study on TLC590 for Managing Postsurgical Pain

NCT06574269 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-02

No results posted yet for this study

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.

Conditions

  • Postsurgical Pain Management

Interventions

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

Sponsors & Collaborators

  • TLC Biopharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Tien-Tzu Tai, MD · Taiwan Liposome Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2026-07-31
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574269 on ClinicalTrials.gov