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 groups8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov