Study of BB-025, Alone and After BB-031, in Healthy Volun... | NCT07202663

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

NCT07202663

Sponsor

Basking Biosciences, Inc.

Status

Completed

Last Update Posted

Apr 6, 2026Actual

Enrollment

72Actual

Phase

Phase 1

Conditions

Pharmacodynamics
Pharmacokinetics
Healthy Volunteers

Interventions

BB-025
BB-031

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 5, 2025Actual

Primary Completion Date

Mar 18, 2026Actual

Completion Date

Mar 18, 2026Actual

First Submitted Date

Sep 24, 2025

First Submission Date that Met QC Criteria

Sep 24, 2025

First Posted Date

Oct 2, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2026

Last Update Posted Date

Apr 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
BB-025	Drug	Reversal agent for BB-031	Single Ascending Dose BB-025 Single Dose Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety as assessed by adverse events (AEs)	Incidence of treatment-emergent AEs	From dosing of study drug to final visit (Day 28)

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics as measured by BB-025 plasma levels	Plasma concentrations of BB-025 (after single dose of drug)	From dosing to 24 hours after dosing
Pharmacokinetics as measured by BB-031 plasma levels

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Chris Argent, MD	Scientia Clinical Research Limited	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Scintia Clinical Research Ltd		Randwick	New South Wales		Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Publication from this study not anticipated to need IPD data to be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided