Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat

This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.

Inclusion criteria

• Male and female over 19 and under 65 years old.
• Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1.
• Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1.
• Stable weight over the last 6 months (body weight change within +/- 5kg), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period.
• Signed informed consent obtained before any study-specific procedure is performed.

Exclusion criteria

• Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
• Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
• Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
• Unable to undergo MRI by neurosis or general weakness.
• History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
• History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
• Inflammation, scars or surgery on the injection area.
• Judged to be unsuitable subject for the clinical trials; ① Abnormal or sagging skin, ② Noticeable platysma band under the chin area, ③ Less or short chin than normal.
• Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy.
• History of or present symptoms of dysphagia.
• Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening.
• Requiring treatment of joint inflammation or a lung disease.
• Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%).
• Type 1 diabetes mellitus who needs insulin treatment.
• Autoimmune disorder as well as those who takes immunodepressant drugs.
• Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel.
• Thyromegaly, thyrotoxicosis, or HIV-positive.
• Diagnosed with malignant tumor within the last 5 years.
• Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, aspartate aminotransferase(AST), alkaline phosphatase > maximum rate of normality x 2.5).
• History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.).
• History of taken a drug that can affect body weight or lipid metabolism such as anorectic agent, steroids, thyroid hormones, amphetamine, cyproheptadine, phenothiazine, or drugs that affect absorption, metabolism, and excretion within 3 months before screening.
• History of other clinical trial studies within 3 months before screening.
• Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, intrauterine contraceptive device, spermicide, condoms etc.).
• Judged to be unsuitable subject for the clinical trials.
• No or unable to using Smart phone to fill in the e-Pro.
• Artificial or cavity teeth filled with metallic material (iron, gold, amalgam, cobalt, titanium) which makes misinterpret MRI.