A Study on TLC590 for Managing Postsurgical Pain

Part of paid clinical trials in Bellaire, Texas.

Sponsor
TLC Biopharmaceuticals, Inc.
Study ID
NCT06574269
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Postsurgical Pain Management

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • TLC590 — DRUG
    Sequentially enrolled into increasing dose cohorts from low to high to receive a dose of TLC590
  • TLC590 — DRUG
    TLC590 Dose 1
  • TLC590 — DRUG
    TLC590 Dose 2
  • TLC590 — DRUG
    The MTD of TLC590
  • TLC590 — DRUG
    TLC590 Dose 3 (The SMC-suggested dose)
  • Ropivacaine — DRUG
    Ropivacaine
  • TLC590 — DRUG
    TLC590

Study Details

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.

Key Dates

Start date
Sep 30, 2024
Status verified
Nov 2025
Primary completion
Jul 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1, Cohort 1
    Bunionectomy: Increasing dose cohorts for TLC590
  • Experimental: Part 1, Cohort 2
    Laparoscopy-assisted Open Ventral Hernia: TLC590
  • Experimental: Part 2, Cohort 3
    Breast Augmentation: TLC590 or Ropivacaine
  • Experimental: Part 2, Cohort 4
    Breast Augmentation: TLC590 or Ropivacaine
  • Experimental: Part 2, Cohort 5
    Breast Augmentation: TLC590 with the SMC-suggested dose
  • Experimental: Part 3, Cohort 6
    Laparoscopy-assisted Open Ventral Hernia: The MTD of TLC590
  • Experimental: Part 3, Cohort 7
    Total Knee Arthroplasty: The MTD of TLC590
  • Experimental: Part 3, Cohort 8
    Abdominoplasty: The MTD of TLC590

Primary Outcome Measure

To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2) [ Time Frame: 0-168 hours ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
First Surgical HospitalBellaireTexas77401-
Memorial Hermann VillageHoustonTexas77043-

Find similar trials in Bellaire, TX

By research site
First Surgical Hospital· Bellaire, TXMemorial Hermann Village· Houston, TX

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