A Study on TLC590 for Managing Postsurgical Pain

ConditionPostsurgical Pain Management

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorTLC Biopharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Able and willing to provide written informed consent

Male or female aged 18 to 70 years, inclusive. For the Part 2 breast augmentation surgical model, only females can be enrolled

Unilateral first metatarsal bunionectomy (Cohort 1)

Laparoscopy-assisted open ventral hernia repair (Cohort 2 and 6)

Disqualifiers

A clinically significant abnormal clinical laboratory test value

Evidence of a clinically significant 12-lead ECG

History of orthostatic hypotension, syncope, or other syncopal attacks

History or any clinical manifestation of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition that has been assessed by the Investigator to be unsuitable for participation in the study

Trial design

Treatments tested in this trial

TLC590
TLC590
TLC590
TLC590
TLC590
Ropivacaine
TLC590

Treatment groups

120 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Locations

First Surgical Hospital77401, BellaireTexas, United States

Memorial Hermann Village77043, HoustonTexas, United States

Sponsors and collaborators

TLC Biopharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov