This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat above the knee and men with Dercum's disease. Each cohort will have 6 subjects who will receive RZL-012.
This is an open label, 2 cohort, clinical trial in women with lipedema with substantial fat above the knee and men with Dercum's disease. * The 1st cohort will be comprised of subjects with Dercum's disease. * The 2nd cohort will be comprised of subjects with lipedema with substantial fat above the knee Within each cohort dosing of the subjects will progress consecutively from one individual to the other with a minimum 7 days between subjects to asses safety. The study design will allow the physicians to monitor safety for at least 7 days prior to dosing the next subject. Cohort 2 will be conducted in a dose escalation manner and the decision to proceed to the next dose level will be made after reviewing all safety data collected by Day 14 within 2+/-1 day of the last dosed subject. The trial will proceed within a cohort provided that no more than one subject experience intolerable side effects in a cohort, and based on the decision made by the Principal Investigator (PI) and the medical monitor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites
University of Arizona Medical Center
Tucson, Arizona, United States
The Incidence of Any Grade 3 or Greater Event Intolerable Side Effect Experienced in a Cohort
Trial will proceed as long as no more than one subject experiences an intolerable side effect in a cohort
Time frame: 0-14 days
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