| Eligibility |
Inclusion Criteria:
1. Male or female, aged 18 years to 64 years old (at Screening), inclusive.
2. Body mass index (BMI) >18.5 kg/m2 at Screening and Day 1.
3. Has confirmed Dercum's disease and/or fulfills the following clinical criteria of
Dercum's disease in localized nodular form. The final diagnosis of disease is in the
opinion of the PI.
1. Chronic pain (> 3 months) in the adipose tissue
2. Pain in and around multiple lipomas.
4. Has at least 4 painful and well defined lipomas with a diameter of =1.0 cm and =6.0 cm
as determined by ultrasound. Excluding lipomas in proximity to vulnerable anatomic
structures, including the salivary glands, lymph nodes, muscles, and along the
anatomic landmarks of the marginal mandibular nerve.
5. Generally considered healthy according to medical history, physical examination,
electrocardiogram (ECG), and laboratory evaluation.
6. Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of the PI or
designee, is physically and mentally capable of participating in the study, and
willing to adhere to study procedures.
Exclusion Criteria:
1. Women of childbearing potential (WOCBP) who are not willing to commit to an acceptable
contraceptive regimen from the time of Screening and throughout study participation
until 90 days after the last IP dose, or who are currently pregnant or lactating. Male
participants who are not willing to commit to an acceptable contraceptive method.
Female participants who are not WOCBP are not required to use contraception.
2. Participants that are unable to tolerate subcutaneous injections.
3. Participants that are diagnosed with another disorder with similar characteristics as
Dercum's Disease.
4. Participants that are diagnosed with coagulation disorders or is receiving
anticoagulant/antiplatelet therapy or medications or dietary supplements, which
inhibit coagulation or platelet aggregation.
5. Participants who has fasting glucose concentration >200 mg/dL, delayed wound healing,
bleeding risk, or any diabetic risks which, in the opinion of PI or designee, is
inappropriate to participate in the study.
6. Participants with any clinically significant cardiac, hepatic, renal or
neurologic/psychiatric disorders that in the opinion of the PI places the participant
at significant risk.
7. Participants with positive blood screen for Hepatitis B surface antigen (HBsAg),
Hepatitis C virus, or Human immunodeficiency virus (HIV).
8. Participants with clinical history of active primary or secondary immunodeficiency,
autoimmune disease, or is undergoing chronic steroid or immunosuppressive therapy.
9. Participants with active, suspected, 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 the skin and in situ squamous cell carcinoma of the
skin would be eligible as per PI's discretion.
10. Participants with abnormal skin, local skin conditions, or body modifications at the
treatment area, which in the opinion of the PI, is inappropriate for participation in
the study, including but not limited to prior wound, scar tissue, infection in the
treated area, or tatoo in the treated area.
11. Participants requiring continual use of the following therapeutic agents during the
study: terfenadine, buspirone, fexofenadine, 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 participant requires
the abovementioned therapeutic agents during the study for any reason, they should not
be used for at least 2 days before dosing and until 1 day postdose.
12. Participants that undergone aesthetic procedure (eg, liposuction, cryolipolysis,
ultrasonic lipolysis, low level laser therapy [LLLT], lipolysis injection) to the
region to be treated before Screening or during the study.
13. Participants who are unable to receive local anesthesia.
14. Participants with known allergies or sensitivities to the IP or its components.
15. Participants that are in use of other investigational drug or device within 4 weeks
prior to Screening.
16. Participant who has undergone vaccination (including with a live-attenuated vaccine)
within 14 days prior to administration of the IP.
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