| Eligibility |
Inclusion Criteria:
A subject can participate in the study only if all the following criteria are met:
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 MWC =80.0 cm at Screening and Day 1.
4. Subcutaneous fat thickness of at least 3.00 cm (30.0 mm) by pinch method (measured by
calibrated caliper) surrounding the navel at Screening and Day 1.
5. 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:
A subject who meets any of the following criteria will not be eligible to enter the study:
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. 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 nonchildbearing 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 cardiovascular disease, or shows clinically significant abnormal
findings in ECG at Screening.
5. Subject with active or prior history of malignancies (except for successfully treated
non-invasive basal cell carcinoma) 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, 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 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 to the region to be treated within 6 months before Screening.
9. Subject is on prescription or over-the-counter weight reduction medication or weight
reduction programs within 3 months before Screening.
10. Subject is undergoing chronic steroid or immunosuppressive therapy.
11. Requiring continual use of the following therapeutic agents during the study:
S-mephenytoin, terfenadine, buspirone, fexofenadine, breast cancer resistance protein
(BCRP) substrates (such as mitoxantrone, methotrexate, topotecan, nitrofurantoin,
dipyridamole, statins, etc.), cytochrome P450 3A4 inhibitor, or non-steroidal
anti-inflammatory drugs (NSAIDs). 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.
12. Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
13. Subjects with known allergies or sensitivities to the study drug and/or excipients.
14. Subjects with inadequate liver function at Screening defined as aspartate
aminotransferase, alanine aminotransferase, alkaline phosphatase, total bilirubin, or
gamma-glutamyl transferase >1.5 × ULN. A subject with an elevated liver chemistry test
up to 1.5 × ULN at Screening should be evaluated by the Investigator to exclude
pre-existing liver disease associated with mild elevation of liver chemistry tests. If
the mild elevation is assessed by the Investigator as not clinically significant or
related to non-alcoholic fatty liver, the subject may be eligible if the follow-up
tests show an unchanged or reducing value from the initial Screening value. A subject
with marginally elevated fasting unconjugated serum bilirubin with documented
Gilbert's syndrome, and no other cause for the elevated bilirubin on investigation,
may be eligible.
15. 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. A subject with serum urea
between 1 to 1.5 × ULN at Screening, but an eGFR >60mL/min/1.73 m2 and no other renal
risk factors, should be re-tested prior to declaring the subject as eligible. The
subject may be eligible if the fasting serum creatinine is not rising nor the eGFR
falling, the urinary albumin/creatinine ratio remain <3 mg/mmol.
16. Use of other investigational drug or device within 4 weeks prior to Screening.
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