NCT07202663CompletedPhase 1
Study of BB-025, Alone and After BB-031, in Healthy Volunteers
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
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 24 Sept 2025
- Start date
- 5 Nov 2025
- Primary completion date
- 18 Mar 2026
- Lead sponsor
- Basking Biosciences, Inc.
- Diseases
- Stroke
- NCT number
- NCT07202663
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 72
- From 5 Nov 2025 to the primary completion date, 18 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery during the study
- 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
Other illness
- Familial bleeding disorder or individual or family history of bleeding diathesis or coagulopathy
- Contraindication to anticoagulation or increased bleeding risks
- History of peptic ulcer disease, gastrointestinal or genitourinary bleed, severe trauma, fracture, major surgery of biopsy of parenchymal organ within past 3 months
Lab values
- Use of prescription medications known to affect platelet function
- Use of NSAIDs, aspirin, anti-platelet or anti-coagulation therapy within 10 days of dosing
- History of thrombocytosis, high platelet count, intracranial bleeding, aneurysm, stroke, vascular disease
Other
- Pregnant or lactating females
- Females with active menstruation on day of dosing
- Any clinically significant abnormality at screening
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Scintia Clinical Research Ltd Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.