Evaluation to Assess Safety and Tolerability of DM199 in Subjects With Acute Ischemic Stroke "REMEDY"

Not yet recruiting

Phase 2 Results N/A

Trial Description

This is a Phase II study to assess the safety and tolerability of DM199 in acute ischemic stroke patients. The study will be randomized, placebo controlled at multiple centers.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo Comparator: Phosphate buffered saline
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.
  • Recombinant human tissue kallikrein Drug
    Other Names: DM199
    Intervention Desc: Recombinant human tissue kallikrein
    ARM 1: Kind: Experimental
    Label: Recombinant human tissue kallikrein
    Description: A single IV infusion of 1 microgram/kg followed by 8 subcutaneous injections of 3 microgram/kg occurring every 72 hours.

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.3 90 Days
Secondary Changes from baseline to Day 90 of NIH Stroke Scale. 90 Days
Secondary Changes from baseline to Day 90 of Barthel Index. 90 Days
Secondary Changes from baseline to Day 90 of Modified Rankin Scale. 90 Days

Sponsors