| Eligibility |
Inclusion Criteria:
1. Body mass index (BMI) >18.5 and <32 kg/m2 and body weight =50 kg at Screening and Day
1.
2. Subject has sufficient thigh subcutaneous fat thickness of at least 1.50 cm (15.0 mm)
and up to 5.00 cm (50.0 mm) measured by ultrasound, surrounding the center of
treatment area at Screening and Day 1.
3. Subject has stable body weight (identified as = 5% weight change) for at least 3
months before Screening and during the study.
4. 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.
5. Voluntarily signs the Informed Consent Form (ICF) 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 90 days after the last investigational product (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 =12 months of
amenorrhea with a follicle stimulating hormone (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.
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 fasting hemoglobin A1c (HbA1c) = 9%, delayed would healing, or any
diabetic risks which, in the opinion of Investigator, is inappropriate to participate
in the study.
4. Subject has a clinically significant cardiovascular disease and abnormal findings in
electrocardiogram (ECG).
5. 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.
6. 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.
7. 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.
8. 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 area to be treated,
3. Grade III cellulite (Nürnberger and Muller scale, Nürnberger F, 1978) at the area
to be treated,
4. Skin folding on treatment area when the subject is in the supine position,
5. Sensory loss or dysesthesia in the area to be treated,
6. Evidence of any cause of enlargement in the area to be treated other than
localized subcutaneous fat,
7. Tattoos on the area to be treated.
9. Subject who has undergone the following procedures:
1. Previous 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,
5. Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, low level laser
therapy (LLLT), lipolysis injection to the region to be treated within 12 months
before Screening or during the study.
10. Subject is on prescription or over-the-counter (OTC) 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: 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.
13. Unable to receive topical anesthesia (e.g., history of hypersensitivity to Benzocaine,
lidocaine, or Tetracaine).
14. Subjects with known allergies or sensitivities to the IP or its components.
15. 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 × upper limit of
normal (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
|
