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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Not Determined

Treatments: Drug: Placebo; Drug: BGB-23339

Study type: Interventional

Funder types: Industry

Identifiers

NCT05093270

BGB-23339-101

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 4 patient groups

Part A Dose Escalation (Single Ascending Dose)

Experimental group

Description:

Up to 5 dose levels of BGB-23339 or Placebo

Treatment:

Drug: BGB-23339

Drug: Placebo

Part B Dose Escalation (Multiple Ascending Dose)

Experimental group

Description:

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

Treatment:

Drug: BGB-23339

Drug: Placebo

Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study)

Experimental group

Description:

Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only)

Treatment:

Drug: BGB-23339

Drug: Placebo

Part D (Food-Effect Study)

Experimental group

Description:

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

Treatment:

Drug: BGB-23339