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

NCT ID: NCT05093270

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2022-12-26

Brief Summary

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

Conditions

Not Determined

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Part A Dose Escalation (Single Ascending Dose)

Up to 5 dose levels of BGB-23339 or Placebo

Group Type: EXPERIMENTAL

BGB-23339

Intervention Type: DRUG

Administered orally as a tablet

Placebo

Intervention Type: DRUG

Administered orally as a tablet

Part B Dose Escalation (Multiple Ascending Dose)

Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A

Group Type: EXPERIMENTAL

BGB-23339

Intervention Type: DRUG

Administered orally as a tablet

Placebo

Intervention Type: DRUG

Administered orally as a tablet

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)

Group Type: EXPERIMENTAL

BGB-23339

Intervention Type: DRUG

Administered orally as a tablet

Placebo

Intervention Type: DRUG

Administered orally as a tablet

Part D (Food-Effect Study)

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

Group Type: EXPERIMENTAL

BGB-23339

Intervention Type: DRUG

Administered orally as a tablet

Interventions

BGB-23339

Administered orally as a tablet

Intervention Type: DRUG

Placebo

Administered orally as a tablet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Q PHARM

Herston, Queensland, Australia

Nucleus Network

Melbourne, Victoria, Australia

The Affiliated Hospital of Qingdao University Branch West Coast

Qingdao, Shandong, China

Countries

Australia; China

Other Identifiers

BGB-23339-101

Identifier Type: -

Identifier Source: org_study_id