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

NCT05093270 | Completed Phase 1 DMC

• 1 other identifier: BGB-23339-101
• Study Type: interventional
• Target: 92
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Not Determined

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• 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

Study Arms (4)

Part A Dose Escalation (Single Ascending Dose)

EXPERIMENTAL

Up to 5 dose levels of BGB-23339 or Placebo

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

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)

Drug: BGB-23339; Drug: Placebo

Part D (Food-Effect Study)

EXPERIMENTAL

Three single dose levels of BGB-23339 under different feeding conditions

Drug: BGB-23339

Interventions

BGB-23339 DRUG

Administered orally as a tablet

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)

Placebo DRUG

Administered orally as a tablet

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)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (3)

Q PHARM

Herston, Queensland, QLD 4006, Australia

Location

Nucleus Network

Melbourne, Victoria, VIC 3004, Australia

Location

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong, 266555, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: October 26, 2021
• Study Start: November 15, 2021
• Primary Completion: September 15, 2022
• Study Completion: December 26, 2022
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (2); CN (1)