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

Overseen By BeiGene

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 11 weeks

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy participants, it is likely that you should not be on any regular medications that could affect the study results.

What is the purpose of this trial?

This trial tests a new drug called BGB-23339 in healthy Japanese and Caucasian people. It aims to find out if there are any differences in safety, tolerability, and how the body processes the drug between these two groups.

Eligibility Criteria

Inclusion Criteria

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of BGB-23339 or placebo to evaluate safety, tolerability, and pharmacokinetics

Up to 11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BGB-23339
• Placebo

Participant Groups

Group I: Part B: Caucasian cohort Experimental Treatment 2 Interventions

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

Group II: Part A: Japanese cohort Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+