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.

Inclusion Criteria

• Men and women 18-65 years old.
• Subjects with Body Mass Index 15 pounds in the past year)
• Males or females in the age of fertility agree to use a double-barrier contraceptive device (e.g., condom and spermicide) for 4 weeks after treatment with RZL 012.
• Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
• Subjects must sign an IRB approved informed consent indicating they are aware of the investigational nature of the study.

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from study participation:

• Unable to tolerate subcutaneous injection.
• Pregnant or lactating women.
• Subjects with dysfunctional gallbladder activity, e.g. underwent cholecystectomy or cholecystitis.
• 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
• Treatment with botulinum toxin injections in the neck or chin area within 6 months before screening.
• Excessive submental skin laxity.
• Any Scars, unshaven hair, tattoos or jewelry on or near the proposed treatment area
• Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study
• An active dermatitis or open wound in the proposed treatment area
• An active bacterial, fungal, or viral infection in the proposed treatment area
• Pre-existing skin condition in the submental region that may confound evaluation or analysis, at investigator discretion
• Previously treated with focused ultrasound, radiofrequency, cryolipolysis, liposuction, sodium deoxycholate to the submental region within the previous 6 months
• Pre-existing neurological or gastrointestinal condition leading to dysphagia, dysphonia or facial nerve palsy
• 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
• Must not have a planned fat reduction procedure of any variety to the submental region for the duration of the study
• Must not have planned significant alterations in diet or physical activity that may result in significant fluctuations in weight.
• Subjects with medication or history of coagulopathy.
• Allergic subjects to Bendaryl.
• Subjects treated chronically at least 3 months prior to study entry with systemic steroids or immunosuppressive drugs.
• Subjects treated chronically at least one week prior to study entry with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
• Current participation or participation within 3 months prior to the start of this study in a drug or other investigational research study.
• Claustrophobia or MRI incompatible device or implant.