Study of BB-025, Alone and After BB-031, in Healthy Volunteers

A Single Center, Two-part, Double-blind, Randomized, Placebo-controlled, Dose-escalation, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BB-025 or Placebo, Alone and Following a Single Dose of BB-031, in Healthy Volunteers

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.

Inclusion Criteria:

• 18-55 years of age
• Ability to provide written consent
• Weight 50-100 kg with BMI 18-32 kg/m2
• Willingness to use contraceptives
• Negative results for alcohol and drugs of abuse

Exclusion Criteria:

• Pregnant or lactating females
• Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
• Females with active menstruation on day of dosing
• Use of prescription medications known to affect platelet function
• Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
• Contraindication to anticoagulation or increased bleeding risks
• History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
• History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
• Planned surgery during the study
• Any clinically significant abnormality at screening
• Use of investigational drug in past 30 days or 5 half lives
• Concurrent enrollment in another clinical study or more than 4 clinical studies in past 12 months
• Any prior history of substance abuse or treatment or positive urine screen for drugs of abuse or positive breathalyzer test