A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031
Up to 5 cohorts of 8 healthy volunteers for a total of 40 volunteers will be randomized to either DTRI-031 or matching placebo (6 active:2 placebo). Two sentinel subjects, one randomized to each group, will be dosed at least 1 day prior to dosing of the remaining subjects in a cohort. Subjects will complete a screening visit up to 28 days prior to administration of study drug to confirm eligibility. Eligible subjects will arrive at the phase 1 unit up to 24 hours prior to Day 1 and remain until completion of 24-hour assessments. Subjects will return for a Day 7 follow-up visit and receive a safety assessment telephone call on Day 28. A Safety Review Committee will review individual subject and aggregate group safety data following each dose-based study cohort and recommend whether the trial should continue to the next cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Nucleus Network
Melbourne, Victoria, Australia
Safety as assessed by adverse events (AEs)
Incidence of treatment-emergent AEs
Time frame: From dosing (DTRI-031 or placebo) to final visit (Day 28)
Pharmacokinetics as measured by DTRI-031 plasma levels
Plasma concentration of DTRI-031 (after single dose of drug)
Time frame: From dosing to 24 hours after dosing
Plasma von Willebrand Factor (vWF) levels
Level of vWF following single administration of drug
Time frame: From dosing to 24 hours after dosing
Platelet Function
Whole blood platelet function closure times
Time frame: From dosing to 24 hours after dosing
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