Healthy Volunteers, Pharmacodynamics, Pharmacokinetics
Conditions
Keywords
Basking Biosciences, BB-025, BB-031, Reversal agent, Stroke, Acute Ischemic Stroke
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.
Interventions
DRUGBB-025
Reversal agent for BB-031
DRUGBB-031
RNA aptamer
Sponsors
Basking Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A randomized, placebo-controlled, double-blind, dose escalation to evaluate the safety, PK and PD of a single dose of investigational drug BB-025 or placebo, alone and following a single dose of BB-031, in healthy volunteers
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by adverse events (AEs) | From dosing of study drug to final visit (Day 28) | Incidence of treatment-emergent AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORChris Argent, MD
Scientia Clinical Research Limited
Outcome results
None listed