Status:
WITHDRAWN
Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects
Lead Sponsor:
BeiGene
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
Detailed 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 Japane...
Eligibility Criteria
Inclusion
- Each subject must meet all of the following inclusion criteria to be considered eligible for participation in this study:
- Signed informed consent form (ICF) and able to comply with study requirements
- 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:
- 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.
- 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.
- 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
- Subjects who meet any of the following criteria will be excluded from this study:
- Medical Conditions
- 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
- 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
- Positive HBV, HCV and HIV test
- History or risk for tuberculosis (TB)
Key Trial Info
Start Date :
February 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05387668
Start Date
February 17 2022
End Date
October 17 2022
Last Update
December 16 2022
Active Locations (1)
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1
PPD
Las Vegas, Nevada, United States, 89113