| Eligibility |
Inclusion Criteria:
1. Male or female, aged 18 years to 64 years old (at Screening), inclusive.
2. Body mass index (BMI) greater than 18.5 and less than 35 kg/m2 and body weight greater
than or equal to 50 kg at Screening and Day 1.
3. Subject has subcutaneous fat thickness surrounding the center of localized area of
treatment. For stage 2, abdominal skinfold thickness of at least 3.00 cm (30.0 mm) and
up to 8.00 cm (80.0 mm) by pinch method (measured by calibrated caliper) at Screening.
4. Subject has stable body weight (identified as less than or equal to 5% weight change
per subject report) for at least 3 months before Screening and during the study.
5. Subject who has maintained a stable lifestyle (e.g. exercise, eating patterns, and
smoking habit) per subject report for at least 3 months before Screening and during
the study.
6. 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 IP dose, or who is currently pregnant or
lactating. Male subject who is not willing to commit to an acceptable contraceptive
method.
Note: Subjects who are not of childbearing potential are not required to use
contraception. Females with no childbearing potential are defined as who have been
surgically sterilized (hysterectomy or bilateral oophorectomy) or who are
post-menopausal (defined as at least 50 years with greater than or equal to 12 months
of amenorrhea with a FSH greater than 40 IU/L).
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 hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed wound 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. Subject with a history of Trypanophobia, the extreme fear of medical procedures
involving injections or needles, or who experience vasovagal syncope and faint or pass
out at the sight of blood or a needle.
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 and fat folding on abdomen
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 abdominal or thigh subcutaneous fat,
7. Tattoos on the area to be treated.
9. Subject who has undergone the following procedures:
1. Previous surgery which caused scar tissues on the anticipated treatment area
before Screening or during the study, except laparoscopic surgery and surgery
which causes very small scar tissues would be eligible as per Investigator's
discretion,
2. Liposuction to the region to be treated before Screening or during the study,
3. Esthetic procedure e.g. cryolipolysis, ultrasonic lipolysis, LLLT, lipolysis
injection to the region to be treated within 12 months before Screening or during
the study.
4. Using medication which is delivered via subcutaneous injection at the treatment
area during the study period.
10. Subject is on prescription or 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, with the exception
of oral steroid inhalation indicated for asthma management or topical steroid
application for skin conditions that are not directly applied or indirectly affect the
treatment area.
12. Requiring continual use of the following therapeutic agents during the study:
terfenadine (Teldane), buspirone (Buspar), fexofenadine (Fexotabs, Tefodine, Telfast,
Xergic, Allegra, etc.), any medication that is known to strongly inhibit or induce CYP
enzymes, sensitive CYP substrates or drugs with narrow therapeutic index, in the
opinion of the investigator, may affect the evaluation of the study product or place
the participant at undue risk.
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 and until 1 day post-dose.
13. Unable to receive topical anesthesia (e.g., history of hypersensitivity to lidocaine).
14. Subjects with known allergies or sensitivities to the study treatment or its
components.
15. Subjects with liver cirrhosis or 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)
greater than 3.0 × upper limit of normal (ULN), or 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.
16. Subjects with any renal impairment, defined as abnormal serum creatinine, and urea
greater than 1.5 × ULN or estimated glomerular filtration rate (eGFR) less than 90
mL/min/1.73 m2. Subjects who are currently on dialysis should be excluded.
Subjects with an eGFR greater than or equal to 60 and less than 90 mL/min/1.73 m2 at
Screening should be evaluated by the Investigator to exclude pre-existing renal
disease or associated dysfunction. If mild decrease in eGFR is assessed by the
Investigator as not clinically significant or not related to dysfunction, the subjects
may be eligible upon the Investigator's assessment.
17. Use of other investigational drug or device within 12 weeks prior to Screening.
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