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BG-71332

Phase 1

Healthy Volunteers | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: Apr 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07141511A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy AdultsPHASE1 COMPLETED 24 — — Sep 24, 2025Feb 23, 2026Apr 22, 20261 Australia
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Study Endpoints
Primary Endpoints
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for zanubrutinib
Predose and up to 72 hours post dose
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for sonrotoclax
Predose and up to 72 hours post dose
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for zanubrutinib
Predose and up to 72 hours post dose
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for sonrotoclax
Predose and up to 72 hours post dose
Maximum observed plasma concentration (Cmax) of zanubrutinib
Predose and up to 72 hours post dose
Maximum observed plasma concentration (Cmax) of sonrotoclax
Predose and up to 72 hours post dose
Secondary Endpoints
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to 30 days after last dose, up to approximately 47 days
Number of participants with laboratory abnormalities
Up to 30 days after last dose, up to approximately 47 days
Number of participants with clinically significant abnormal electrocardiogram (ECG) values
Up to 30 days after last dose, up to approximately 47 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
BG-71332, Zanubrutinib + SonrotoclaxEXPERIMENTALParticipants will receive the following treatments in one of six sequences: one dose of BG-71332 with a high-fat meal, one dose of BG-71332 in a fasted state, and one dose of zanubrutinib and sonrotoclax administered together with a high-fat meal.
Interventions
NameTypeDescription
BG-71332DRUGAdministered orally
ZanubrutinibDRUGAdministered orally
SonrotoclaxDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator. * An absolute B-cell count of \>200 cells/μL. * Female participants must be of non...

Countries:Australia
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07141511TRIAL_REMOVED: changed
LOWMay 24, 2026NCT07141511studyFirstPostDate: changed