First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants

September 18, 2025 updated by: BeiGene

A First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Subjects

This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, QLD 4006
        • Q Pharm
    • Victoria
      • Melbourne, Victoria, Australia, VIC 3004
        • Nucleus Network
  • China
    • Shandong
      • Qingdao, Shandong, China, 266555
        • The Affiliated Hospital of Qingdao University Branch West Coast

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 years on the day of signing the ICF (or the legal age of consent) and of Chinese descent for Part C
  3. Participants are in good general health as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
  4. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)
  5. A nonsterile man with a female partner of childbearing potential must be willing to use a highly effective method of birth control from the time of study enrollment until 90 days after the last dose of study drug

  6. A woman of no childbearing potential must meet at least one of the following criteria:

    1. Postmenopausal status, defined as: cessation of regular menses for ≥ 12 consecutive months (menopause confirmed by Follicular Stimulating Hormone [FSH] levels and Luteinizing Hormone [LH] levels as defined by the established reference ranges)
    2. Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months).

Exclusion Criteria:

  1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data
  2. Abnormal blood pressure as determined by the investigator
  3. Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
  4. Any malignancies within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  5. Past or intended use of prescription medication ≤ 14 days and over-the-counter (OTC) medication including herbal, vitamins and dietary supplements ≤ 7 days before randomization
  6. Live vaccine ≤ 30 days, and/or vaccine of any type ≤ 14 days before randomization
  7. Has received an investigational product within the following time before randomization: 3 months, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer)
  8. Participation in a prior study that would result in loss of blood or blood products in excess of 500 mL within 56 days before randomization
  9. Exposure to ≥ 4 new chemical entities within 12 months before randomization
  10. Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or ≤ 3 months before randomization
  11. Regular alcohol consumption ≤ 3 months before randomization
  12. Regular use of recreational drugs
  13. Current use and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 14 days before randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A Dose Escalation (Single Ascending Dose)
Up to 5 dose levels of BGB-23339 or Placebo
Drug: BGB-23339
Administered orally as a tablet
Drug: Placebo
Administered orally as a tablet
Experimental: Part B Dose Escalation (Multiple Ascending Dose)
Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A
Drug: BGB-23339
Administered orally as a tablet
Drug: Placebo
Administered orally as a tablet
Experimental: Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study)
Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)
Drug: BGB-23339
Administered orally as a tablet
Drug: Placebo
Administered orally as a tablet
Experimental: Part D (Food-Effect Study)
Three single dose levels of BGB-23339 under different feeding conditions
Drug: BGB-23339
Administered orally as a tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 7 weeks
Up to approximately 7 weeks
Number of participants with clinically significant changes from baseline in vital signs
Time Frame: Up to approximately 4 weeks
Vital signs include blood pressure and pulse rate
Up to approximately 4 weeks
Number of participants with clinically significant changes from baseline in clinical laboratory values
Time Frame: Up to approximately 4 weeks
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Up to approximately 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D
Time Frame: Up to approximately 4 weeks
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
Time Frame: Up to approximately 4 weeks
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
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks
Maximum observed plasma concentration (Cmax) for Parts A, B, C and D
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks
Time to maximum plasma concentration (Tmax) for Parts A, B, C and D
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks
Trough plasma concentration (Ctrough) for Parts A, B, and C
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks
Apparent terminal elimination half-life (t½) for Parts A, B, C and D
Time Frame: Up to approximately 4 weeks
in fed and fasted states for BGB-23339
Up to approximately 4 weeks
Apparent systemic clearance (CL/F) for Parts A, B, and C
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks
Apparent volume of distribution (Vz/F) for Parts A, B, and C
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks
Accumulation ratios, and metabolite to parent ratio for BGB-23339 and its metabolite BGB-25808 as appropriate for Parts A, B, C and D
Time Frame: Up to approximately 4 weeks
Up to approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BeiGene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BGB-23339-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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