Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke "ASSENT"

Recruiting

Phase 1/2 Results N/A

Trial Description

This is a Phase 1b/2, double-blind (Principal Investigators and study subjects blinded, Sponsor unblinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DS-1040b in subjects with Acute Ischemic Stroke (AIS).

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo IV infusion
    ARM 1: Kind: Experimental
    Label: placebo
    Description: placebo IV infusion
  • DS-1040b Drug
    Intervention Desc: IV infusion of DS-1040b
    ARM 1: Kind: Experimental
    Label: DS-1040b
    Description: IV infusion of DS-1040b ranging from 0.6mg to 9.6mg of DS-1040b.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number and severity of adverse events 18 months Yes
Secondary Pharmacokinetic parameter, area under concentration curve (AUC) of DS-1040b in plasma 24 hours after dose No
Secondary Pharmacokinetic parameter, tmax of DS-1040b in plasma 24 hours after dose No
Secondary Pharmacokinetic parameter, maximum concentration Cmax of DS-1040b in plasma 24 hours after dose No
Secondary Pharmacokinetic parameter, amount of drug excreted in urine of DS-1040b in plasma 24 hours after dose No
Secondary analysis for thrombin-activatable fibrinolysis inhibitor (TAFIa) antigen in plasma 24 hours after dose No
Secondary analysis for clot lysis in plasma 24 hours after dose No
Secondary analysis for D-dimer in plasma 24 hours after dose No
Secondary analysis for total thrombin-activatable fibrinolysis inhibitor in plasma 24 hours after dose No
Secondary Number of participants with AIS and a visible occlusion demonstrated on brain imaging at predose demonstrating recanalization at 24 hours. day 1 No
Secondary Change by number and percentage in National Institute of Health Stroke Scale (NIHSS) score from predose to 30 days post-dose. day 0 (baseline) to day 30 Yes
Secondary Change by number and percentage in modified Rankin Scale (mRS) score from baseline to day 90 day 0 (baseline) to day 90 No

Sponsors