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Completed

NCT Number: NCT07202663

Study of BB-025, Alone and After 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.

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Key information

Conditions

Pharmacodynamics Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Healthy Volunteers Ischemic Stroke Nervous System Diseases Pharmacokinetics Stroke Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scintia Clinical Research Ltd

Randwick, New South Wales, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BB-025

Drug

Reversal agent for BB-031

BB-031

Drug

RNA aptamer

Primary outcomes

  1. Safety as assessed by adverse events (AEs)

    Time frame: From dosing of study drug to final visit (Day 28)

    Incidence of treatment-emergent AEs

Secondary outcomes

  1. Pharmacokinetics as measured by BB-025 plasma levels

    Time frame: From dosing to 24 hours after dosing

    Plasma concentrations of BB-025 (after single dose of drug)

  2. Pharmacokinetics as measured by BB-031 plasma levels

    Time frame: From dosing to 24 hours after dosing

    Plasma concentrations of BB-031 (after single dose of drug)

  3. Pharmacokinetics as measured by BB-025/BB-031 Complex plasma levels

    Time frame: 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

  4. Plasma von Willebrand Factor (vWF) Levels

    Time frame: From dosing of BB-031 or BB-025 to 24 hours after dosing of BB-025

    Level of vWF following administration of study drug

  5. Platelet Function

    Time frame: From dosing of BB-031 or BB-025 to 24 hours after BB-025 dosing

    Whole blood platelet function closure times

Sponsors and collaborators

Lead sponsor

Basking Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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