| Eligibility |
Inclusion Criteria:
1. Male/female aged 18 years to 64 years old (at Screening), inclusive.
2. Body mass index >18.5 and <35 kg/m2 and body weight =50 kg at Screening and Day 1.
3. Has WC between 80.0 cm and 110.0 cm at Screening and Day 1.
4. Subcutaneous fat thickness of at least 3.00 cm (30.0 mm) and up to 6.00 cm (60.0 mm)
by pinch method (measured by calibrated caliper) surrounding the center of treatment
area at Screening and Day 1.
5. Subject has stable body weight for at least 3 months before Screening and during the
study.
6. Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and
smoking habit) for at least 3 months before Screening and during the study.
7. Voluntarily signs the Informed Consent Form and, in the opinion of the Investigator or
delegate, is physically and mentally capable of participating in the study, and
willing to adhere to study procedures.
Exclusion Criteria:
1. 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. For details on contraception, refer section 6.11.
Females who have been surgically sterilized (hysterectomy or bilateral oophorectomy)
or who are postmenopausal (e.g., defined as at least 50 years with =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.
2. Subject diagnosed with coagulation disorders or is receiving
anticoagulant/antiplatelet therapy or medications or dietary supplements, which impede
coagulation or platelet aggregation.
3. Subject has diabetes or glycated hemoglobin =6.5% (48 mmol/mol) or fasting blood sugar
=7 mmol/L.
4. Subject has a clinically significant cardiovascular disease and abnormal findings in
ECG.
5. Subject with active or prior history of malignancies (except for successfully treated
basal cell carcinoma) within 5 years before Screening or being worked-up for a
possible malignancy.
6. 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:
1. Active HIV infection: positive HIV Ag/Ab combo test;
2. 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.
3. Active hepatitis C virus (HCV) infection: positive HCV antibody.
7. 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:
1. Skin manifestations of a systemic disease,
2. Any abnormality of the skin or soft tissues of the abdominal wall in the area to
be treated,
3. Skin or superficial tissue that does not lie flat on its own when the subject is
in the supine position,
4. Sensory loss or dysesthesia in the area to be treated,
5. Evidence of any cause of enlargement in the abdominal area other than localized
subcutaneous fat,
6. Tattoos on the area to be treated.
8. Subject who has hernia
9. Subject who has undergone the following procedures:
1. Previous open or laparoscopic abdominal surgery in the anticipated treatment
area,
2. Cardiac pacemakers or any implantable electrical device,
3. Metal implants of any type in the area to be treated,
4. Esthetic procedure i.e. liposuction to the region to be treated within 12 months
before Screening or during the study,
5. 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.
10. Subject is on prescription or over-the-counter weight reduction medication or weight
reduction programs within 3 months before Screening or during the study.
11. Subject is undergoing chronic steroid or immunosuppressive therapy.
12. Requiring continual use of the following therapeutic agents during the study:1
S-mephenytoin (Mesantoin), terfenadine (Teldane), buspirone (Buspar), fexofenadine
(Fexotabs, Tefodine, Telfast, Xergic, Allegra).
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 2 days prior to
dosing until 1 day post-dose, whichever is later.
13. Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
14. Subjects with known allergies or sensitivities to the study drug and/or excipients
15. Subjects with inadequate liver function at Screening defined as aspartate
aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, or
gamma-glutamyl transferase >3.0 × ULN.
16. 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.
17. Use of other investigational drug or device within 4 weeks prior to Screening.
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