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Local Anesthetic

Part 1, Cohort 2 for Post Operative Pain Management

Phase 2
Waitlist Available
Research Sponsored by Taiwan Liposome Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Able and willing to provide written informed consent
2. Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-168 hours
Awards & highlights

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) in a highly vascular surgical model. 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.

Who is the study for?
This trial is for individuals undergoing certain surgeries (like bunionectomy, hernia repair, breast augmentation, tummy tuck, or knee replacement) who need pain management post-operation. Specific eligibility criteria are not provided here.
What is being tested?
The study is testing TLC590 to see how it's processed in the body and its safety across different surgeries. It compares TLC590 with a standard pain relief injection called ropivacaine to find the highest dose patients can tolerate without severe side effects.
What are the potential side effects?
While specific side effects of TLC590 aren't listed here, similar drugs often cause issues like nausea, numbness around the injection site, low blood pressure, dizziness or headaches. The trial will monitor these closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-168 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-168 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2)
To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2)

Trial Design

8Treatment groups
Experimental Treatment
Group I: Part 3, Cohort 8Experimental Treatment1 Intervention
Abdominoplasty: The MTD of TLC590
Group II: Part 3, Cohort 7Experimental Treatment1 Intervention
Total Knee Arthroplasty: The MTD of TLC590
Group III: Part 3, Cohort 6Experimental Treatment1 Intervention
Laparoscopy-assisted Open Ventral Hernia: The MTD of TLC590
Group IV: Part 2, Cohort 5Experimental Treatment1 Intervention
Breast Augmentation: TLC590 with the SMC-suggested dose
Group V: Part 2, Cohort 4Experimental Treatment2 Interventions
Breast Augmentation: TLC590 or Ropivacaine
Group VI: Part 2, Cohort 3Experimental Treatment2 Interventions
Breast Augmentation: TLC590 or Ropivacaine
Group VII: Part 1, Cohort 2Experimental Treatment1 Intervention
Laparoscopy-assisted Open Ventral Hernia: TLC590
Group VIII: Part 1, Cohort 1Experimental Treatment1 Intervention
Bunionectomy: Increasing dose cohorts for TLC590
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TLC590
2018
Completed Phase 2
~220
Ropivacaine
2017
Completed Phase 4
~1960

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Who is running the clinical trial?

Taiwan Liposome CompanyLead Sponsor
18 Previous Clinical Trials
1,718 Total Patients Enrolled
Tien-Tzu Tai, MDStudy DirectorTaiwan Liposome Company
~80 spots leftby Jul 2026
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