Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06574269
PHASE2

A Study on TLC590 for Managing Postsurgical Pain

Sponsor: TLC Biopharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-09-30

Completion Date

2026-08

Last Updated

2025-12-02

Healthy Volunteers

No

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

Locations (2)

First Surgical Hospital

Bellaire, Texas, United States

Memorial Hermann Village

Houston, Texas, United States