Status:
COMPLETED
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.
Lead Sponsor:
Raziel Therapeutics Ltd.
Conditions:
Submental Fat
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 wil...
Detailed Description
This is a single blinded, randomized, placebo-controlled, 2-cohort clinical study in healthy volunteers. Cohort 1 will be comprised of 8 active (RZL-012) and 4 placebo subjects. Cohort 2 will be compr...
Eligibility Criteria
Inclusion
- Men and women 18-65 years old.
- Subjects with Body Mass Index \<35
- Subjects must have submental skin fold thickness greater than 1.5 cm as measured with calipers.
- Males must be willing to be clean shaved for all study visits.
- Patient weight must be stable (no fluctuation of \>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
- 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.
Key Trial Info
Start Date :
February 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04086823
Start Date
February 25 2020
End Date
September 16 2020
Last Update
November 18 2023
Active Locations (1)
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1
DeNova Research
Chicago, Illinois, United States, 60611