An Open Label, Phase 1b, Ascending Dose Study of DM199

Completed

Phase 1 Results N/A

Trial Description

This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.

Conditions

Interventions

  • Recombinant human tissue kallikrein Drug
    Other Names: DM199
    Intervention Desc: Intravenous DM199
    ARM 1: Kind: Experimental
    Label: Low dose
    Description: Recombinant human tissue kallikrein
    ARM 2: Kind: Experimental
    Label: Medium low dose
    Description: Recombinant human tissue kallikrein
    ARM 3: Kind: Experimental
    Label: Medium high dose
    Description: Recombinant human tissue kallikrein
    ARM 4: Kind: Experimental
    Label: High dose
    Description: Recombinant human tissue kallikrein
    ARM 5: Kind: Experimental
    Label: Low dose (Part A)
    Description: Recombinant human tissue kallikrein
    ARM 6: Kind: Experimental
    Label: Medium low dose (Part A)
    Description: Recombinant human tissue kallikrein
    ARM 7: Kind: Experimental
    Label: Medium high dose (Part A)
    Description: Recombinant human tissue kallikrein
    ARM 8: Kind: Experimental
    Label: High dose (Part A)
    Description: Recombinant human tissue kallikrein
    ARM 9: Kind: Experimental
    Label: Subcutaneous (Part B)
    Description: Recombinant human tissue kallikrein
    ARM 10: Kind: Experimental
    Label: IV (Part B)
    Description: Recombinant human tissue kallikrein

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 30 days Yes
Secondary Concentration of DM199 in plasma 3 days No
Secondary Concentration of bradykinin in plasma 3 days No

Sponsors