This is an open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of MT1002 for injection following intravenous bolus/infusion ascending dose administration.
An initial, single dose escalation study of MT1002 for injection for injection in heathy subjects will be performed to evaluate safety, pharmacokinetics, and pharmacodynamics after intravenous bolus and infusion administration. A total of 36 subjects (6 subjects per cohort) in 6 dose levels . At each dose level, a single sentinel subject will be dosed first. Sentinel subjects will receive a phone call at 48 hours ±4 hours to inquire about their status. If no dose-limiting toxicity is observed for 48 hours post-dose, the remaining 5 subjects in that dose level will be treated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Study drug will be administered by an intravenous bolus dose followed by an infusion of 4 hours.
Pharmaron CPC, Inc.
Baltimore, Maryland, United States
Maximum observed concentration (Cmax)
Maximum observed concentration following intravenous bolus/infusion administration of MT1002 for injection
Time frame: 24 hours
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax)
Time frame: 24 hours
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last)
Area under the concentration-time curve (AUC) from Hour 0 to the last measurable concentration (AUC0-last)
Time frame: 24 hours
AUC extrapolated to infinity (AUC0-∞)
AUC extrapolated to infinity (AUC0-∞)
Time frame: 24 hours
Activated clotting time (ACT)
Activated clotting time (ACT)
Time frame: 24 hours
Activated partial thromboplastin time (aPTT)
Activated partial thromboplastin time (aPTT)
Time frame: 24 hours
International normalized ratio (INR)
International normalized ratio (INR)
Time frame: 24 hours
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