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
Basking Biosciences, Inc.
72 participants
Nov 5, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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
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Interventions
Reversal agent for BB-031
RNA aptamer
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07202663