Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1, Cohort 1Experimental treatment 1 intervention
Group B: Part 1, Cohort 2Experimental treatment 1 intervention
Group C: Part 2, Cohort 3Experimental treatment 2 interventions
Group D: Part 2, Cohort 4Experimental treatment 2 interventions
Group E: Part 2, Cohort 5Experimental treatment 1 intervention
Group F: Part 3, Cohort 6Experimental treatment 1 intervention
Group G: Part 3, Cohort 7Experimental treatment 1 intervention
Group H: Part 3, Cohort 8Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To determine the relative bioavailability of TLC590 compared to ropivacaine HCl injection (Part 2)

Time frame
0-168 hours
2

To determine the MTD of TLC590 in subjects with breast augmentation surgery (Part 2)

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TLC Biopharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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