Status:
RECRUITING
Study of BB-025, Alone and After BB-031, in Healthy Volunteers
Lead Sponsor:
Basking Biosciences, Inc.
Conditions:
Pharmacodynamics
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT07202663
Start Date
November 5 2025
End Date
June 1 2026
Last Update
November 25 2025
Active Locations (1)
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1
Scintia Clinical Research Ltd
Randwick, New South Wales, Australia