Evaluation of Safety and Efficacy of RZL-012 in Subjects Seeking Fat Reduction in the Flanks
Condition: Flank Mass
Intervention: RZL-012; Placebo
Intervention description: small synthetic molecule for submental fat reduction; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each of the subject's flanks will be randomized for RZL-012 and placebo injections.
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A total of 12 subjects will be injected with RZL-012 and placebo. Each of the subject's
      flanks will be randomized for each of the treatment. A total of 24 flanks will be randomized
      in the double blind phase. They will be monitored for safety and efficacy for 12 weeks. After
      codes opening, a second treatment cycle on the previously untreated contralateral flank will
      be done. Subjects will be monitored for safety and efficacy for additional 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a male or female subject between the ages of 18 and 65 years, inclusive.

          -  Has body mass index (BMI) BMI of ≥ 22 and < 30.

          -  Has clearly visible and palpable fat in the flanks

          -  Has symmetrical appearance of right and left flanks

          -  Agrees to maintain weight (i.e., within 5% of body weight) by not making any changes
             in diet.

          -  Agree to avoid exposure of the treated area to the sun for at least 1 month after each
             treatment session.

          -  If female, is not pregnant or breastfeeding based on the following:

               1. agree to the use of highly effective contraceptive methods for at least 2 weeks
                  before baseline until 28 days after the last day of study drug and a negative
                  urine pregnancy test at screening and baseline; or

               2. is of nonchildbearing potential defined as clinically infertile as the result of
                  surgical sterilization (hysterectomy, bilateral tubal ligation, and/or bilateral
                  oophorectomy); or

               3. is confirmed postmenopausal status (defined as either having amenorrhea for ≥ 12
                  consecutive months without another cause, having documented serum
                  follicle-stimulating hormone (FSH) level > 40 mIU/mL, or having another
                  documented medical condition (e.g., was born without a uterus))

          -  If male (with or without vasectomy), agree to the use of highly effective
             contraceptive methods, e.g. condom, from study baseline until 7 days after the last
             day of study drug.

          -  Is willing to avoid strenuous exercise for seven (7) days post treatment.

          -  Is motivated to adhere to the visit schedule and protocol requirements.

          -  Is willing and able to sign an Institutional Review Board (IRB) approved informed
             consent form (ICF) indicating that they are aware of the investigational nature of the
             study.

        Exclusion Criteria:

          -  Is unable to tolerate subcutaneous injections.

          -  Has dysfunctional gallbladder activity (e.g., underwent cholecystectomy or
             cholecystitis).

          -  Has an uncontrolled systemic disease that is not stabilized (i.e., cardiovascular
             disease, mental illness).

          -  Has used anticoagulation therapies that may increase bleeding or bruising (i.e.,
             aspirin, ibuprofen, vitamins, and herbal preparations) for seven (7) days prior to
             treatment.

          -  Has medication or a history of coagulopathy.

          -  Has a history or family history of venous thrombotic disease.

          -  Had a non-invasive fat reduction and/or body contouring procedure in the flanks within
             the past 12 months.

          -  Has any scars, unshaven hair, tattoos, on or near the proposed treatment area.

          -  Has significant history or current evidence of a medical, psychological or other
             disorder that, in the Investigator's opinion, would preclude enrollment in the study.

          -  Has an active dermatitis or open wound in the proposed treatment area.

          -  Abnormal coagulation profile including: activated partial thromboplastin time (aPTT) >
             ULN, international normalized ratio (INR) > ULN reference range (> 1.3), prothrombin
             time (PT) > ULN.

          -  Has an active bacterial, fungal, or viral infection in the proposed treatment area.

          -  Has known allergic reactions to any injectables.

          -  Has been treated chronically in the past 3 months prior to study entry with systemic
             steroids or immunosuppressive drugs.

          -  Has been treated chronically at least one (1) week prior to study entry with
             non-steroidal anti-inflammatory drugs (NSAIDs).

          -  Current participation or participation within three (3) months prior to the start of
             this study in a drug or other investigational research study