Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-23339 · 1 trial · 1 indication
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 ...
BGB-23339 is an investigational small molecule developed by BeOne Medicines Ltd. It is a Phase 1 clinical-stage compound that has been studied in healthy adult volunteers. No specific disease indication has been established for it, and it has not been approved by the FDA.
BGB-23339 targets TYK2, a tyrosine kinase. By acting on TYK2, the compound is designed to modulate signaling through this kinase pathway. TYK2 is the only molecular target identified for BGB-23339, and it is being developed as a small molecule therapeutic.
BGB-23339 is developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is the sponsor of the clinical program for this investigational TYK2-targeting small molecule.
BGB-23339 is in Phase 1 development. It is investigational and has not been approved by the FDA. Its single Phase 1 trial has been completed, and no active trials are currently listed for the compound.
BGB-23339 has been evaluated in one Phase 1 trial, NCT05093270, titled a first-in-human, single- and multiple-ascending dose and food-effect study in healthy participants. That trial enrolled 92 participants, was randomized, double-blind, and controlled, and was conducted in Australia and China. It is now completed.