Study of BB-025, Alone and After BB-031, in Healthy Volunteers
- Conditions
- PharmacodynamicsPharmacokineticsHealthy Volunteers
- Interventions
- Registration Number
- NCT07202663
- Lead Sponsor
- Basking Biosciences, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Ascending Dose BB-025 BB-025 Drug: BB-025, Investigational Drug Single Dose Placebo BB-025 Drug: Matched placebo to BB-025 cohorts Single Dose BB-031 BB-031 Drug: BB-031, Investigational Drug
- Primary Outcome Measures
Name Time Method Safety as assessed by adverse events (AEs) From dosing of study drug to final visit (Day 28) Incidence of treatment-emergent AEs
- Secondary Outcome Measures
Name Time Method Pharmacokinetics as measured by BB-025 plasma levels From dosing to 24 hours after dosing Plasma concentrations of BB-025 (after single dose of drug)
Pharmacokinetics as measured by BB-031 plasma levels From dosing to 24 hours after dosing Plasma concentrations of BB-031 (after single dose of drug)
Pharmacokinetics as measured by BB-025/BB-031 Complex plasma levels From dosing of BB-031 through 24 hours after dosing of BB-025 Plasma concentration of BB-025/BB-031 Complex after a single dose of each drug
Plasma von Willebrand Factor (vWF) Levels From dosing of BB-031 or BB-025 to 24 hours after dosing of BB-025 Level of vWF following administration of study drug
Platelet Function From dosing of BB-031 or BB-025 to 24 hours after BB-025 dosing Whole blood platelet function closure times
Trial Locations
- Locations (1)
Scintia Clinical Research Ltd
🇦🇺Randwick, New South Wales, Australia
Scintia Clinical Research Ltd🇦🇺Randwick, New South Wales, AustraliaStudy CoordinatorContact+61 1800 727 874recruitment@scientiaclinicalresearch.com.au