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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacodynamics Pharmacokinetics Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single Ascending Dose BB-025

Drug: BB-025, Investigational Drug

Group Type EXPERIMENTAL

BB-025

Intervention Type DRUG

Reversal agent for BB-031

Single Dose Placebo

Drug: Matched placebo to BB-025 cohorts

Group Type PLACEBO_COMPARATOR

BB-025

Intervention Type DRUG

Reversal agent for BB-031

Single Dose BB-031

Drug: BB-031, Investigational Drug

Group Type EXPERIMENTAL

BB-031

Intervention Type DRUG

RNA aptamer

Interventions

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BB-025

Reversal agent for BB-031

Intervention Type DRUG

BB-031

RNA aptamer

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes