PharmacodynamicsPhase 1NCT07202663
Study of BB-025, Alone and After BB-031, in Healthy Volunteers
A Phase 1 study testing BB-025 and BB-031 in people with Pharmacodynamics and Pharmacokinetics, run by Basking Biosciences, Inc. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacodynamics, Pharmacokinetics, Healthy Volunteers
- What is being tested?
- BB-025 and BB-031
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Nov 2025to 18 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- BB-025, BB-031
- Keywords
- Basking Biosciences, BB-025, BB-031, Reversal agent, Stroke, Acute Ischemic Stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-025Drug
Reversal agent for BB-031
BB-031Drug
RNA aptamer
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose BB-025 | Experimental | Drug: BB-025, Investigational Drug Receives: Drug: BB-025 |
| Single Dose Placebo | Placebo comparator | Drug: Matched placebo to BB-025 cohorts Receives: Drug: BB-025 |
| Single Dose BB-031 | Experimental | Drug: BB-031, Investigational Drug Receives: Drug: BB-031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by adverse events (AEs)
Incidence of treatment-emergent AEs
Measured: From dosing of study drug to final visit (Day 28)
Secondary outcomes (5)
Pharmacokinetics as measured by BB-025 plasma levels
Plasma concentrations of BB-025 (after single dose of drug)
Measured: From dosing to 24 hours after dosing
Pharmacokinetics as measured by BB-031 plasma levels
Plasma concentrations of BB-031 (after single dose of drug)
Measured: From dosing to 24 hours after dosing
Pharmacokinetics as measured by BB-025/BB-031 Complex plasma levels
Plasma concentration of BB-025/BB-031 Complex after a single dose of each drug
Measured: From dosing of BB-031 through 24 hours after dosing of BB-025
Plasma von Willebrand Factor (vWF) Levels
Level of vWF following administration of study drug
Measured: From dosing of BB-031 or BB-025 to 24 hours after dosing of BB-025
Platelet Function
Whole blood platelet function closure times
Measured: From dosing of BB-031 or BB-025 to 24 hours after BB-025 dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start5 Nov 2025
- Primary completion18 Mar 2026
- Study completion18 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacodynamicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basking Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Argent, MD, Principal investigator, Scientia Clinical Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202663
- Sponsor's protocol ID
- BB-CLIN-102
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication from this study not anticipated to need IPD data to be shared
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07202663
- Acronym / sponsor ID
- BB-CLIN-102
- Conditions
- Pharmacodynamics, Pharmacokinetics, Healthy Volunteers
- Keywords
- Basking Biosciences, BB-025, BB-031, Reversal agent, Stroke, Acute Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Basking Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 18 Mar 2026 (actual)
- Study completion
- 18 Mar 2026 (actual)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose BB-025 | Experimental | Drug: BB-025Drug: BB-025, Investigational Drug |
| Single Dose Placebo | Placebo comparator | Drug: BB-025Drug: Matched placebo to BB-025 cohorts |
| Single Dose BB-031 | Experimental | Drug: BB-031Drug: BB-031, Investigational Drug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB-025Reversal agent for BB-031 | Drug | Single Ascending Dose BB-025, Single Dose Placebo |
| BB-031RNA aptamer | Drug | Single Dose BB-031 |
Primary outcome
Safety as assessed by adverse events (AEs)
Time frame: From dosing of study drug to final visit (Day 28)
Incidence of treatment-emergent AEs
5 secondary outcomes
Pharmacokinetics as measured by BB-025 plasma levels
Time frame: From dosing to 24 hours after dosing
Pharmacokinetics as measured by BB-031 plasma levels
Time frame: From dosing to 24 hours after dosing
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 von Willebrand Factor (vWF) Levels
Time frame: From dosing of BB-031 or BB-025 to 24 hours after dosing of BB-025
Platelet Function
Time frame: From dosing of BB-031 or BB-025 to 24 hours after BB-025 dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No. Publication from this study not anticipated to need IPD data to be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Argent, MD principal investigator
Scientia Clinical Research Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BB-025 and BB-031 in people with Pharmacodynamics and Pharmacokinetics, run by Basking Biosciences, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by adverse events (AEs) (time frame: From dosing of study drug to final visit (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.