CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
VM202 2 mg +3 morebiological
Likely dose
VM202 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00696124
NCT00696124Phase 1Completed
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Phase 1, Dose-Escalation Study to Assess the Safety and Tolerability of VM202 (Engensis) in Subjects With Critical Limb Ischemia

Helixmith Co., Ltd.·interventional·Posted Jun 12, 2008·Updated Oct 6, 2025

In Brief

A Phase 1 clinical trial evaluating VM202 2 mg, VM202 4 mg, and 2 other interventions for Critical Limb Ischemia. Completed, enrolled 12 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 12, 2008
Enrollment StartApr 3, 2007
Primary CompletionOct 19, 2009
Study CompletionDec 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.1 years ago

Interventions

VM202 2 mgbiological

2 mg intramuscular injection with the first half of the total dose given on Day 1 and the second half on Day 15

VM202 4 mgbiological

4 mg intramuscular injection, with half of the total dose given on Day 1 and the second half given on Day 15

VM202 8 mgbiological

8 mg intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.

VM202 16 mgbiological

16 mg dose intramuscular injection. The first half of the total dose given on Day 1 and the second half on Day 15.