Study of BB-025, Alone and After BB-031, in Healthy Volunteers

NCT07202663 | Recruiting Phase 1

• 1 other identifier: BB-CLIN-102
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacodynamics; Pharmacokinetics; Healthy Volunteers

Keywords

Basking Biosciences; BB-025; BB-031; Reversal agent; Stroke; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Safety as assessed by adverse events (AEs)

  Incidence of treatment-emergent AEs

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

Secondary Outcomes (5)

• Pharmacokinetics as measured by BB-025 plasma levels

  From dosing to 24 hours after dosing

• Pharmacokinetics as measured by BB-031 plasma levels

  From dosing to 24 hours after dosing

• 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 von Willebrand Factor (vWF) Levels

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

• Platelet Function

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

Study Arms (3)

Single Ascending Dose BB-025

EXPERIMENTAL

Drug: BB-025, Investigational Drug

Drug: BB-025

Single Dose Placebo

PLACEBO COMPARATOR

Drug: Matched placebo to BB-025 cohorts

Drug: BB-025

Single Dose BB-031

EXPERIMENTAL

Drug: BB-031, Investigational Drug

Drug: BB-031

Interventions

BB-025 DRUG

Reversal agent for BB-031

Single Ascending Dose BB-025; Single Dose Placebo

BB-031 DRUG

RNA aptamer

Single Dose BB-031

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basking Biosciences, Inc.: lead

Study Sites (1)

Scintia Clinical Research Ltd

Randwick, New South Wales, Australia

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chris Argent, MD

  Scientia Clinical Research Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Director

CONTACT

9196184721; snelson@baskingbiosciences.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: November 5, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)