First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants
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ClinicalTrials.gov Identifier: NCT05093270 |
Recruitment Status :
Completed
First Posted : October 26, 2021
Last Update Posted : February 15, 2023
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Condition or disease | Intervention/treatment | Phase |
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Not Determined | Drug: BGB-23339 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 92 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
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 |
Actual Study Start Date : | November 15, 2021 |
Actual Primary Completion Date : | September 15, 2022 |
Actual Study Completion Date : | December 26, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Part A Dose Escalation (Single Ascending Dose)
Up to 5 dose levels of BGB-23339 or Placebo
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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
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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)
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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
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Drug: BGB-23339
Administered orally as a tablet |
- 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
- 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 ]in fed and fasted states for BGB-23339
- 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 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
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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).
Exclusion Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05093270
Australia, Queensland | |
Q-Pharm Pty Ltd | |
Herston, Queensland, Australia | |
Australia, Victoria | |
Nucleus Network Pty Ltd | |
Geelong, Victoria, Australia, 3220 | |
Nucleus Network Pty Ltd | |
Melbourne, Victoria, Australia, 3004 | |
China, Qingdao | |
The Affiliated Hospital of Qingdao University | |
Huangdao, Qingdao, China, 266500 |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT05093270 |
Other Study ID Numbers: |
BGB-23339-101 |
First Posted: | October 26, 2021 Key Record Dates |
Last Update Posted: | February 15, 2023 |
Last Verified: | February 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |