A Phase 2a Study to Evaluate the Preliminary Efficacy and Safety of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers

Exclusion Criteria34

• A subject who meets any of the following criteria will not be eligible to enter the study:
• Female subject of childbearing potential who is not willing to commit to an acceptable contraceptive regimen with her partner from the time of Screening and throughout study participation until 12 weeks after the last study drug dose, or who is currently pregnant or lactating. Male subject who is not willing to commit to an acceptable contraceptive method.
• Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy) or who are postmenopausal (e.g., defined as at least 50 years with equal to or longer than 12 months of amenorrhea with a follicle stimulating hormone >40 IU/L) are considered to be of non-childbearing potential. Subjects who are not of childbearing potential are not required to use contraception.
• Subject diagnosed with coagulation disorders or is receiving anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede coagulation or platelet aggregation.
• Subject has diabetes or glycated hemoglobin (HbA1c) equal to or greater than 6.5% (48 mmol/mol) or fasting blood sugar (FBS) equal to or greater than 7 mmol/L.
• Subject has a clinically significant cardiovascular disease and abnormal findings in ECG.
• Subject with active or prior history of malignancies or being worked-up for a possible malignancy within 5 years before Screening.
• Subject with a history of human immunodeficiency virus (HIV)-1, hepatitis B, or hepatitis C infections, or subjects with active HIV, hepatitis B, or hepatitis C infections at Screening.
• a. Active HIV infection: positive HIV Ag/Ab combo test,
• b. Active hepatitis B virus (HBV) infection: positive HBV surface antigen (HBsAg). Subjects with negative HBsAg but with positive HBV core antibody, with or without positive HBV surface antibody will also be excluded. However, subjects with negative HBsAg, negative HBV core antibody, and positive HBV surface antibody may be included,
• c. Active hepatitis C virus (HCV): positive HCV antibody.
• Subject has abnormal skin or local skin conditions at the treatment area, which in the opinion of Investigator, is inappropriate to participate in the study, including but not limited to any of the following:
• a. Skin manifestations of a systemic disease,
• b. Any abnormality of the skin or soft tissues of the abdominal wall in the area to be treated,
• c. Skin or superficial tissue that does not lie flat on its own when the subject is in the supine position,
• d. Sensory loss or dysesthesia in the area to be treated,
• e. Evidence of any cause of enlargement in the abdominal area other than localized subcutaneous fat,
• f. Tattoos on the area to be treated.
• Subject who has hernia.
• Subject who has undergone the following procedures:
• a. Previous open or laparoscopic abdominal surgery in the anticipated treatment area,
• b. Cardiac pacemakers or any implantable electrical device,
• c. Metal implants of any type in the area to be treated,
• d. Esthetic procedure i.e. liposuction to the region to be treated within 12 months before Screening or during the study,
• e. Esthetic procedure i.e. cryolipolysis, ultrasonic lipolysis, low level laser therapy, lipolysis injection to the region to be treated within 6 months before Screening or during the study.
• Subject is on prescription or over-the-counter weight reduction medication or weight reduction programs within 3 months of Screening or during the study.
• Subject is undergoing chronic steroid or immunosuppressive therapy.
• Requiring continual use of the following therapeutic agents during the study: S-mephenytoin (Mesantoin), terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast, Xergic, Allegra, etc.).
• If a subject needs to use the above mentioned therapeutic agents during the study for any reason, these therapeutic agents should not be used at least for 48 hours prior to dosing until 24 hours post-dose or the collection of the last PK sample, whichever is later.
• Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
• Subjects with known allergies or sensitivities to the study drug and/or excipients.
• Subjects with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, or gamma-glutamyl transferase (GGT) >3.0 × upper limit of normal (ULN).
• Subjects with inadequate renal function, defined as abnormal serum creatinine, and urea >1.5 × ULN or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m^2. Subjects who are currently on dialysis should be excluded.
• Use of other investigational drug or device within 4 weeks prior to Screening.