A Single Blind, Randomized, Placebo-controlled, Phase 2a, 2-cohort Study for the Evaluation of Safety and Efficacy of RZL-012 for Submental Fat Reduction in Healthy Volunteers.

Exclusion Criteria

• •Subjects meeting any of the following criteria will be excluded from study participation:
• •1. Unable to tolerate subcutaneous injection.
• •2. Pregnant or lactating women.
• •3. Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
• •4. Any uncontrolled systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
• •5. Treatment with botulinum toxin injections in the neck or chin area within 6 months before screening.
• •6. Excessive submental skin laxity.
• •7. Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
• •8. Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
• •9. An active dermatitis or open wound in the proposed treatment area
• •10. An active bacterial, fungal, or viral infection in the proposed treatment area
• •11. Pre-existing skin condition in the submental region that may confound evaluation or analysis, at investigator discretion
• •12. Previously treated with focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate to the submental region within the previous 6 months
• •13. Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
• •14. Pre-existing medical condition other than increased submental fat that may result in increased submental fullness such as but not limited to thyroid enlargement, goiter, cervical lymphadenopathy etc., at investigator discretion
• •15. Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
• •16. Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight.
• •17. Subjects with medication or history of coagulopathy.
• •18. Allergic subjects to Bendaryl.
• •19. Subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
• •20. Subjects treated chronically at least one week prior to study entry with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
• •21. Current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.
• •22. Claustrophobia or MRI incompatible device or implant.