Not DeterminedPhase 1NCT05093270
First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants
A Phase 1 study testing BGB-23339 in people with Not Determined, run by BeiGene at 3 sites in 2 countries.
Trial summary
This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Not Determined
- What is being tested?
- BGB-23339
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Nov 2021to 26 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form (ICF) and able to comply with study requirements
- 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
- 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
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)
- 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
- A woman of no childbearing potential must meet at least one of the following criteria:
- 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)
- Surgically sterile (eg, hysterectomy, oophorectomy, or tubal ligation for at least the past 3 months).
Who cannot join
- 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
- Abnormal blood pressure as determined by the investigator
- Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
- 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
- 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
- Live vaccine ≤ 30 days, and/or vaccine of any type ≤ 14 days before randomization
Show all 14Show fewer
- 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)
- 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
- Exposure to ≥ 4 new chemical entities within 12 months before randomization
- Presence of hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) at screening or ≤ 3 months before randomization
- Regular alcohol consumption ≤ 3 months before randomization
- Regular use of recreational drugs
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Q PHARM
Herston, Queensland, QLD 4006
Nucleus Network
Melbourne, Victoria, VIC 3004
China1 site
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, 266555
About this study
Official title: 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
- Conditions
- Not Determined
- Being tested
- BGB-23339, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-23339Drug
Administered orally as a tablet
PlaceboDrug
Administered orally as a tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation (Single Ascending Dose) | Experimental | Up to 5 dose levels of BGB-23339 or Placebo Receives: Drug: BGB-23339; Drug: Placebo |
| Part B Dose Escalation (Multiple Ascending Dose) | Experimental | Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A Receives: Drug: BGB-23339; Drug: Placebo |
| Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study) | Experimental | Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only) Receives: Drug: BGB-23339; Drug: Placebo |
| Part D (Food-Effect Study) | Experimental | Three single dose levels of BGB-23339 under different feeding conditions Receives: Drug: BGB-23339 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs)
Measured: Up to approximately 7 weeks
Number of participants with clinically significant changes from baseline in vital signs
Vital signs include blood pressure and pulse rate
Measured: Up to approximately 4 weeks
Number of participants with clinically significant changes from baseline in clinical laboratory values
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
Measured: Up to approximately 4 weeks
Secondary outcomes (11)
Area under the plasma concentration-time curve from time zero to last quantifiable time (AUClast) for Parts A, B, C and D
Measured: 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
Measured: 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
Measured: 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
Measured: Up to approximately 4 weeks
Maximum observed plasma concentration (Cmax) for Parts A, B, C and D
Measured: Up to approximately 4 weeks
Time to maximum plasma concentration (Tmax) for Parts A, B, C and D
Measured: Up to approximately 4 weeks
Trough plasma concentration (Ctrough) for Parts A, B, and C
Measured: Up to approximately 4 weeks
Apparent terminal elimination half-life (t½) for Parts A, B, C and D
in fed and fasted states for BGB-23339
Measured: Up to approximately 4 weeks
Apparent systemic clearance (CL/F) for Parts A, B, and C
Measured: Up to approximately 4 weeks
Apparent volume of distribution (Vz/F) for Parts A, B, and C
Measured: 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
Measured: Up to approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start15 Nov 2021
- Primary completion15 Sep 2022
- Study completion26 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Not DeterminedStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093270
- Sponsor's protocol ID
- BGB-23339-101
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05093270
- Acronym / sponsor ID
- BGB-23339-101
- Conditions
- Not Determined
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 26 Dec 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, and pharmacokinetics of BGB-23339 and food effects in healthy participants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation (Single Ascending Dose) | Experimental | Drug: BGB-23339, Drug: PlaceboUp to 5 dose levels of BGB-23339 or Placebo |
| Part B Dose Escalation (Multiple Ascending Dose) | Experimental | Drug: BGB-23339, Drug: PlaceboUp 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) | Experimental | Drug: BGB-23339, Drug: PlaceboUp 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) | Experimental | Drug: BGB-23339Three single dose levels of BGB-23339 under different feeding conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent form (ICF) and able to comply with study requirements
- 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
- 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
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive)
- 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
Key exclusion criteria (14 listed)
- 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
- Abnormal blood pressure as determined by the investigator
- Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-23339Administered orally as a tablet | Drug | Part A Dose Escalation (Single Ascending Dose), Part B Dose Escalation (Multiple Ascending Dose), Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study), Part D (Food-Effect Study) |
| PlaceboAdministered orally as a tablet | Drug | Part A Dose Escalation (Single Ascending Dose), Part B Dose Escalation (Multiple Ascending Dose), Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study) |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs)
Time frame: 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
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
11 secondary outcomes
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
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
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
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
Maximum observed plasma concentration (Cmax) for Parts A, B, C and D
Time frame: 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
Trough plasma concentration (Ctrough) for Parts A, B, and C
Time frame: 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
Apparent systemic clearance (CL/F) for Parts A, B, and C
Time frame: Up to approximately 4 weeks
Apparent volume of distribution (Vz/F) for Parts A, B, and C
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-23339 in people with Not Determined, run by BeiGene at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 7 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.