Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects

BeiGene

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: BGB-23339

Study type: Interventional

Funder types: Industry

Identifiers

NCT05387668

BGB-23339-102

Details and patient eligibility

About

This study is designed to evaluate the influence of ethnic factors on the safety, tolerability, and pharmacokinetics (PK) of BGB-23339 after multiple dosing under fasting condition in healthy Japanese and Caucasian participants.

Full description

The study comprises 2 parts: Part A is a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Japanese subjects. Part B is a randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and PK profile of BGB-23339 in healthy Caucasian subjects.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Each subject must meet all of the following inclusion criteria to be considered eligible for participation in this study:

1. Signed informed consent form (ICF) and able to comply with study requirements

2. Healthy Japanese or Caucasian men and/or women of no childbearing potential aged ≥ 18 years and ≤ 55 years on the day of signing the ICF (or the legal age of consent), and to be specific:

   1. For Part A only: Eligible Japanese subjects should have both biological parents and 4 biological grandparents of Japanese descent, and their 4 biological grandparents must be born in Japan.
   2. For Part B only: Eligible Caucasian subjects should 1) have both biological parents and 4 biological grandparents of Caucasian descent, and 2) be matched by body weight (± 20% body weight [kg]), height (± 15% height [centimeter (cm)]) and sex to each Japanese subject receiving the highest dose level planned in Part A.

3. Subjects 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

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from this study:

Medical Conditions

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. Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history ≤ 2 months before randomization)
3. 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
4. Positive HBV, HCV and HIV test
5. History or risk for tuberculosis (TB)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Part A: Japanese cohort

Experimental group

Description:

Three ascending dose levels of either BGB-23339 or placebo.

Treatment:

Drug: Placebo

Drug: BGB-23339

Part B: Caucasian cohort

Experimental group

Description:

One dose level of either BGB-23339 or placebo based on data collected in Part A.

Treatment:

Drug: Placebo

Drug: BGB-23339