Critical Limb Ischemia Clinical Trial
Official title:
Phase 1, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 in Subjects With Critical Limb Ischemia
The purpose of this study is to determine the safety, tolerability and preliminary efficacy
of intramuscular injections of VM202 for subjects with critical limb ischemia.
Subjects selected for this study will have critical limb ischemia that has not responded to
standard therapy with symptoms including pain at rest and/or ischemic ulcers.
The study will consist of four (4) cohorts with a total of 3 subjects enrolled in each cohort
to VM202.For each dose cohort, VM202 will be administered as a local intramuscular injection
in 2 divided doses with a 2-week interval between the injections. Preliminary efficacy
(hemodynamic assessments), safety and tolerability will be evaluated at Baseline (screening)
and at designated time points throughout the study.
After all subjects in the first dose cohort have completed the 30-day (+ 2 days) follow-up
visit following the first dose of the study drug, an interim safety evaluation will be
performed with the submission of safety data to the Data Safety Monitoring Committee (DSMC).
If the DSMC recommends continuing the study, the second dose cohort will be treated. This
process will be repeated between the second and third dose cohort and between the third and
fourth dose cohort.
All four dose cohorts will be followed for up to 5 years from the time of the first dose of
study drug administration.
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