Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain
Condition: Abdominoplasty
MeSH terms: Pain, Postoperative
Intervention: CPL-01; Placebo
Intervention description: CPL-01 will be administered; Placebo will be administered
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after
      mini-abdominoplasty
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject provides signed, written informed consent before participation in the study.

          -  Subject is aged ≥18 and ≤70 years at the time of informed consent and is male or
             female.

          -  Subject is scheduled to undergo elective mini-abdominoplasty surgery under general
             anesthesia without collateral procedures.

          -  Female subjects are eligible only if all the following apply:

               1. Not pregnant

               2. Not breastfeeding

               3. Not planning to become pregnant during participation in the study

               4. Committed to the use of an acceptable form of birth control for the duration of
                  the study until at least 30 days after administration of IP.

          -  Male subjects must commit to the use of a reliable method of birth control for the
             duration of the study until at least 30 days after administration of IP or be
             surgically sterile (biologically or surgically).

          -  Subject is free of any physical, mental, or medical conditions which, in the opinion
             of the investigator, make mini-abdominoplasty or study participation inadvisable.

        Exclusion Criteria:

          -  Subject has known, suspected, or reported history of alcohol or drug abuse or
             dependence within the previous 2 years as assessed by the investigator

          -  Subject has impaired liver function (e.g., aspartate aminotransferase/alanine
             aminotransferase greater than 3 times the upper limit of the reference range,
             bilirubin greater than 1.5 times the upper limit of the reference range unless due to
             Gilbert's syndrome, active hepatic disease, evidence of clinically significant liver
             disease, or other condition such as alcoholism, cirrhosis, or hepatitis, etc.) that
             suggests the potential for an increased susceptibility to hepatic toxicity with IP
             exposure.

          -  Subject has clinically significant renal abnormalities (creatinine ≥1.5 × upper limit
             of normal).

          -  Subject has hemoglobin A1c ≥7.0%.

          -  Subject has participated in another clinical study and/or received an IP (marketed or
             premarket) within 30 days before surgery.

          -  Subject has a history of, or positive test results for, human immunodeficiency virus,
             hepatitis B surface antigen, or hepatitis C virus antibody at Screening.

          -  Subject with an upper respiratory infection/cough in the 14 days before surgery.

          -  Subjects with a history of significant postoperative nausea and vomiting.