A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat

Inclusion Criteria:

1. Male or female, aged 18 years to 64 years old (at Screening), inclusive.

2. Body mass index (BMI) > 18.5 and < 30 kg/m2 and body weight ≥ 50 kg at Screening andDay 1.

3. Participant has abdominal fat graded by the Investigator as Grade 3 (moderate) orGrade 4 (severe) using the Clinician-Reported Abdominal Fat Rating Scale via liveevaluation at Screening.

4. Participant has stable body weight (identified as ≤ 3 kg weight change perparticipant report) for at least 3 months before Screening and during the study.

5. Participant who has maintained a stable lifestyle (e.g., exercise, eating patterns,and smoking habit) per participant report for at least 3 months before Screening andduring the study.

6. Voluntarily signs the Informed Consent Form (ICF) and, in the opinion of theInvestigator or delegate, is physically and mentally capable of participating in thestudy, and willing to adhere to study procedures.

Exclusion Criteria:

1. Female participant of childbearing potential who is not willing to commit to anacceptable contraceptive regimen from the time of Screening and throughout studyparticipation until 90 days after the last IP dose, or who is currently pregnant orlactating. Male participant who is not willing to commit to using of a condom andrefraining from sperm donation from the time of the first dose of IP, throughoutstudy participation until 90 days after the last IP dose. Note: Participants who are not of childbearing potential are not required to usecontraception. Females not of childbearing potential are defined as those who havebeen surgically sterilized (hysterectomy or bilateral oophorectomy) or who arepost-menopausal (defined as at least 50 years of age with greater than or equal to 12 months of amenorrhea with a follicle stimulating hormone (FSH) greater than 30IU/L).

2. Participant diagnosed with coagulation disorders or who is receivinganticoagulant/antiplatelet therapy or medications or dietary supplements that impedecoagulation or platelet aggregation.

3. Participant has hemoglobin A1c (HbA1c) greater than or equal to 9%, delayed woundhealing, or poorly controlled diabetes defined as requiring a change in glucosecontrol medications (other than day to day variations in insulin requirements)within the 6 months prior to Screening or for whom a change in glucose controlmedications is anticipated during the study, or any diabetic risks that, in theopinion of Investigator, make the individual an inappropriate candidate for thestudy.

4. Participant with active or prior history of malignancies within 5 years beforeScreening or currently being evaluated for a possible malignancy, with the exceptionof adequately treated basal cell carcinoma of skin and in situ squamous cellcarcinoma of skin at Investigator's discretion.

5. Participant with a history of human immunodeficiency virus (HIV)-1 infection orparticipant with active HIV infection at Screening with positive HIVantigen/antibody (Ag/Ab) combo test.

6. Participant with a history of trypanophobia, the extreme fear of medical proceduresinvolving injections or needles, or who experiences vasovagal syncope and faints atthe sight of blood or a needle.

7. Participant with folding fat or skin on abdomen in standing position.

8. Participant with severe or very severe abdominal visceral fat assessed by theInvestigator using the visceral fat scale.

9. Participant with ventral abdominal or umbilical hernia or previous repair of same.

10. Participant has abnormal skin or local skin conditions at the treatment area, which,in the opinion of Investigator, would increase risk to the participant or inhibitsafety or efficacy evaluation, including but not limited to any of the following:

11. Skin manifestations of a systemic disease,

12. Any abnormality of the skin or soft tissues of the area to be treated, such asscars, striae, dyspigmentation, etc.,

13. Asymmetrical fat on abdomen,

14. Lipomatosis syndromes (familial lipomatosis, nevus lipomatosis, Dercum'sdisease, etc.),

15. Skin laxity on abdomen,

16. Sensory loss or dysesthesia in the area to be treated,

17. Tattoo(s) on the front and/or lateral side of abdomen.

18. Participant who has undergone the following procedures:

19. Previous surgery that caused scar tissues on the anticipated treatment areabefore Screening or during the study, with the exception of laparoscopicsurgery and surgery that resulted in minimal scar tissue determined atInvestigator's discretion,

20. Liposuction or abdominoplasty to the region to be treated before Screening orduring the study,

21. Aesthetic procedure for body contouring or fat reduction, e.g., cryolipolysis,ultrasonic lipolysis, low level laser therapy, EMSculpt, lipolysis injection tothe region to be treated within 12 months before Screening or during the study.

22. Using medication that is delivered via subcutaneous injection at the treatmentarea within 4 weeks before Screening or during the study.

23. Participant is on prescription or OTC weight reduction medication, weight reductionprograms, or use of any GLP-1 agonists (e.g., semaglutide, terzepatide, liraglutide,etc.) (oral or injectable) within 6 months before Screening or during the study.

24. Participant is undergoing chronic steroid or immunosuppressive therapy, with theexception of oral steroid inhalation indicated for asthma management or topicalsteroid application for skin conditions that are not directly applied to orindirectly affect the treatment area.

25. Requiring continual use of any medication that is known to strongly inhibit orinduce CYP1A2 enzymes, sensitive CYP1A2 substrates or drugs with narrow therapeuticindex during the study that, in the opinion of the Investigator, may affect theevaluation of the study product or place the participant at undue risk. Note: If a participant needs to use the above mentioned therapeutic agents duringthe study for any reason, these therapeutic agents should not be used at least for 2days prior to dosing and until 1 day post-dose.

26. Unable to receive local anesthesia (e.g., history of hypersensitivity to lidocaine).

27. Participant with known allergies or sensitivities to the IP or its components,medical history of urticaria, any drug allergy, or seasonal allergy that presentswith skin-related symptoms. Participant with food allergies can be enrolled at thediscretion of Investigator.

28. Participant with liver cirrhosis, with inadequate liver function at Screeningdefined as aspartate aminotransferase (AST), alanine aminotransferase (ALT),alkaline phosphatase, total bilirubin (TBIL), or gamma-glutamyl transferase (GGT)greater than 3.0 × upper limit of normal (ULN), or with any hepatic medicalcondition that would interfere with assessment of safety or efficacy.

29. Participant with any renal impairment, defined as:

30. serum creatinine greater than 1.5 × ULN and blood urea nitrogen (BUN) greaterthan 1.5 × ULN, or

31. estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m2, or whois currently on dialysis. Note: Participant with an eGFR greater than or equal to 60 and less than 90mL/min/1.73 m2 at Screening should be evaluated by the Investigator for pre-existingdisease or associated dysfunction. If mild decrease in eGFR is deemed not clinicallysignificant or not related to dysfunction by the Investigator, the participant willnot be excluded unless the Investigator deems it necessary.

32. Participant with contraindications to MRI imaging.

33. Use of any investigational drug or device within 3 months prior to Screening.