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

Basking Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers; Pharmacodynamics; Pharmacokinetics

Treatments: Drug: BB-025; Drug: BB-031

Study type: Interventional

Funder types: Industry

Identifiers

NCT07202663

BB-CLIN-102

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups, including a placebo group

Single Ascending Dose BB-025

Experimental group

Description:

Drug: BB-025, Investigational Drug

Treatment:

Drug: BB-025

Single Dose Placebo

Placebo Comparator group

Description:

Drug: Matched placebo to BB-025 cohorts

Treatment:

Drug: BB-025

Single Dose BB-031

Experimental group

Description:

Drug: BB-031, Investigational Drug

Treatment:

Drug: BB-031