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BGB-23339

Phase 1

Not Determined | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: Sep 22, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment92

FDA Designations

No designations recorded

Clinical trial landscape

BGB-23339 · 1 trial · 1 indication

Phase 1 1
NCT05093270First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy ParticipantsNot Determined
COMPLETED92 Analytics
PHASE1COMPLETED
First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants
Not DeterminedUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Experiencing Adverse Events (AEs)
Up to approximately 7 weeks
Number of participants with clinically significant changes from baseline in vital signs
Up to approximately 4 weeks

Vital signs include blood pressure and pulse rate

Number of participants with clinically significant changes from baseline in clinical laboratory values
Up to approximately 4 weeks

Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis

Secondary Endpoints

Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D
Up to approximately 4 weeks
Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24) for Part D only
Up to approximately 4 weeks
Area under the plasma concentration-time curve from time zero to end of dosing interval (AUCtau) for Parts A, B, C and D
Up to approximately 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A Dose Escalation (Single Ascending Dose)EXPERIMENTALUp to 5 dose levels of BGB-23339 or Placebo
Part B Dose Escalation (Multiple Ascending Dose)EXPERIMENTALUp to 4 dose levels of BGB-23339 or placebo based on data collected in Part A
Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study)EXPERIMENTALUp to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)
Part D (Food-Effect Study)EXPERIMENTALThree single dose levels of BGB-23339 under different feeding conditions

Interventions

NameTypeDescription
BGB-23339DRUGAdministered orally as a tablet
PlaceboDRUGAdministered orally as a tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Signed informed consent form (ICF) and able to comply with study requirements 2. Healthy men and/or women of no childbearing potential of age ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent) for Parts A, B and D; of age≥ 18 years and ≤ 45 ...

Countries:AustraliaChina
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Frequently asked questions about BGB-23339

What is BGB-23339?

BGB-23339 is an investigational small molecule being developed by BeOne Medicines Ltd. (ticker: ONC). It is currently in Phase 1 clinical development. The specific indication for BGB-23339 has not been determined, and it is being studied in healthy volunteers.

Who makes BGB-23339?

BGB-23339 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed under the ticker ONC. The company is conducting clinical trials for this investigational small molecule, which is currently in Phase 1 development.

What phase is BGB-23339 in?

BGB-23339 is in Phase 1 clinical development. A first-in-human study has been completed, which evaluated single- and multiple-ascending doses and the effect of food in healthy participants. The drug remains investigational and is not yet approved for any use.

What clinical trials is BGB-23339 in?

BGB-23339 has one completed clinical trial, identified as NCT05093270. This was a first-in-human, single- and multiple-ascending dose and food-effect study conducted in healthy participants. The trial enrolled 92 participants and took place in Australia and China.

Is BGB-23339 FDA approved?

BGB-23339 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A first-in-human study has been completed, but the drug has not yet received regulatory approval for any indication.