A Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of CBL 514 Injection on Thigh Subcutaneous Fat

Exclusion Criteria30

• 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 90 days after the last IP 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 post-menopausal (e.g., defined as at least 50 years with greater than or equal to 12 months of amenorrhea with a FSH >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 fasting hemoglobin A1c (HbA1c) great than or equal to 7%.
• Subject has a clinically significant cardiovascular disease and abnormal findings in electrocardiogram (ECG).
• Subject with active or prior history of malignancies within 5 years before Screening or being worked-up for a possible malignancy. Except adequately treated basal cell carcinoma of skin and in situ squamous cell carcinoma of skin would be eligible as per Investigator’s discretion.
• Subject with a history of human immunodeficiency virus (HIV)-1, infection or subjects with active HIV infection at Screening with positive HIV antigen/antibody (Ag/Ab) combo test.
• Subjects with any hepatic medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
• 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 area to be treated,
• c. Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area to be treated,
• d. Skin or superficial tissue that does not lie flat on its own when the subject is in the supine position,
• e. Sensory loss or dysesthesia in the area to be treated,
• f. Evidence of any cause of enlargement in the area to be treated other than localized subcutaneous fat,
• g. Tattoos on the area to be treated.
• Subject who has undergone the following procedures:
• a. Previous surgery in the anticipated treatment area,
• b. Metal implants of any type in the area to be treated,
• c. Esthetic procedure i.e. liposuction to the region to be treated within 12 months before Screening or during the study,
• d. Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, low level laser therapy (LLLT), lipolysis injection to the region to be treated within 6 months before Screening or during the study.
• Subject is on prescription or OTC weight reduction medication or weight reduction programs within 3 months before 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 and until 24 hours post-dose.
• Unable to receive topical anesthesia (e.g., history of hypersensitivity to Benzocaine, lidocaine, or Tetracaine).
• Subjects with known allergies or sensitivities to the IP or its components.
• Subjects with inadequate liver function at Screening defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALKP), total bilirubin (TBIL), or gamma-glutamyl transferase (GGT) >3.0 × 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 m2. Subjects who are currently on dialysis should be excluded.
• Use of other investigational drug or device within 4 weeks prior to Screening.