A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty
The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain? Participants will: Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.
• Subject is male or female aged 18 to 50 years
• Scheduled to undergo an elective partial abdominoplasty under general anesthesia
• Has a body BMI 18.0 to 35 kg/m2
• Has signed informed consent and will comply with the requirements and restrictions of the study
• Meet lifestyle, medication, or other study restrictions
• Subject must agree to study required use of birth control
• Post-surgical (abdominoplasty) pain must meet the study threshold