Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05093270 | First-in-Human, Single- and Multiple-Ascending Dose and Food-Effect Study of BGB-23339 in Healthy Participants | PHASE1 | COMPLETED | 92 | — | — | Nov 15, 2021 | Dec 26, 2022 | Sep 22, 2025 | 3 | Australia, China |
Vital signs include blood pressure and pulse rate
Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis
| Arm | Type | Description |
|---|---|---|
| Part A Dose Escalation (Single Ascending Dose) | EXPERIMENTAL | Up to 5 dose levels of BGB-23339 or Placebo |
| Part B Dose Escalation (Multiple Ascending Dose) | EXPERIMENTAL | Up to 4 dose levels of BGB-23339 or placebo based on data collected in Part A |
| Part C Dose Escalation (Multiple Ascending Dose in Chinese Subjects Sub-study) | EXPERIMENTAL | Up to 2 dose levels of BGB-23339 or placebo based on data collected in Part A and B (conducted in China only) |
| Part D (Food-Effect Study) | EXPERIMENTAL | Three single dose levels of BGB-23339 under different feeding conditions |
| Name | Type | Description |
|---|---|---|
| BGB-23339 | DRUG | Administered orally as a tablet |
| Placebo | DRUG | Administered orally as a tablet |
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 ...