A Study on TLC590 for Managing Postsurgical Pain
Recruiting
Phase 2
Interventional Study
Postsurgical Pain Management
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- TLC Biopharmaceuticals, Inc. · Industry
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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 t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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
3. Scheduled to undergo one of the following elective surgeries, with no additional procedure…
Contacts