The goal of this 2-part clinical trial is to learn about the safety and pharmacokinetics (PK) of a single dose of BB-025 when given on its own and after being given BB-031. Researchers will compare BB-025 to placebo (a look-alike substance that contains no drug) both on its own and after being given a single dose of BB-031 to assess the use of BB-025 as a reversal agent. In the first part of the study, participants will receive a single dose of BB-025 or placebo. They will be followed for 28 days to check if they have any symptoms. In the second part of the study, participants will receive a single dose of BB-031 and then be given either BB-025 or placebo. These participants will also be followed for 28 days to check if they have any symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Scintia Clinical Research Ltd
Randwick, New South Wales, Australia
Safety as assessed by adverse events (AEs)
Incidence of treatment-emergent AEs
Time frame: From dosing of study drug to final visit (Day 28)
Pharmacokinetics as measured by BB-025 plasma levels
Plasma concentrations of BB-025 (after single dose of drug)
Time frame: From dosing to 24 hours after dosing
Pharmacokinetics as measured by BB-031 plasma levels
Plasma concentrations of BB-031 (after single dose of drug)
Time frame: From dosing to 24 hours after dosing
Pharmacokinetics as measured by BB-025/BB-031 Complex plasma levels
Plasma concentration of BB-025/BB-031 Complex after a single dose of each drug
Time frame: From dosing of BB-031 through 24 hours after dosing of BB-025
Plasma von Willebrand Factor (vWF) Levels
Level of vWF following administration of study drug
Time frame: From dosing of BB-031 or BB-025 to 24 hours after dosing of BB-025
Platelet Function
Whole blood platelet function closure times
Time frame: From dosing of BB-031 or BB-025 to 24 hours after BB-025 dosing
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