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

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: Completed
• Conditions: Not Determined
• Intervention / Treatment: Drug: BGB-23339; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 1

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events (AEs)		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	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	Up to approximately 4 weeks

Secondary Outcome Measures

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		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
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for Parts A, B, C, and D		Up to approximately 4 weeks
Maximum observed plasma concentration (Cmax) for Parts A, B, C and D		Up to approximately 4 weeks
Time to maximum plasma concentration (Tmax) for Parts A, B, C and D		Up to approximately 4 weeks
Trough plasma concentration (Ctrough) for Parts A, B, and C		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	Up to approximately 4 weeks
Apparent systemic clearance (CL/F) for Parts A, B, and C		Up to approximately 4 weeks
Apparent volume of distribution (Vz/F) for Parts A, B, and C		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		Up to approximately 4 weeks

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): September 15, 2022
• Study Completion (Actual): December 26, 2022

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID 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