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.
Condition: Submental Fat
Intervention: RZL-012; Placebo
Intervention description: Subcutaneous injection to the submental fat area; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Twenty-Eight (28) subjects (12 for cohort 1 and 16 for cohort 2 ) will be included in the
      study. Subjects in each cohort will be injected with a different dose of RZL-012. The total
      of 28 subjects will be enrolled in 2 clinical sites.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women 18-65 years old.

          2. Subjects with Body Mass Index <35

          3. Subjects must have submental skin fold thickness greater than 1.5 cm as measured with
             calipers.

          4. Males must be willing to be clean shaved for all study visits.

          5. Patient weight must be stable (no fluctuation of >15 pounds in the past year)

          6. 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.

          7. Subjects must be able to adhere to the visit schedule and protocol requirements and be
             available to complete the study.

          8. 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:

          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.