Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB-DXP604 · 1 trial · 1 indication
A TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline on or after the administration of study drug and up to 30 days after the dose of study drug. An SAE is any untoward medical occurrence that, at any dose results in death, or is life threatening, or requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect, or is considered a significant medical AE by the investigator based on medical judgment.
| Arm | Type | Description |
|---|---|---|
| Part 1: BGB-DXP604 | EXPERIMENTAL | Part 1A: Single low dose of BGB-DXP604 or placebo; Part 1B: Single high dose of BGB-DXP604 or placebo |
| Part 2 : BGB-DXP604 + BGB-DXP593 | EXPERIMENTAL | Single dose of BGB-DXP593 followed by a single dose of BGB-DXP604 or placebo |
| Name | Type | Description |
|---|---|---|
| BGB-DXP604 | DRUG | Administered as intravenous (IV) infusion over 30 to 60 minutes |
| BGB-DXP593 | DRUG | Administered as intravenous (IV) infusion over 30 to 60 minutes |
| Placebo | DRUG | Placebo to match BGB-DXP593 |
Key Inclusion Criteria: 1. Participants 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 2. Body weight ≥ 50 kg and body mass index (B...
BGB-DXP604 is an investigational small molecule developed by BeOne Medicines Ltd. It has been studied in a Phase 1 clinical trial in healthy participants, both as a single agent and in combination with BGB-DXP593. It is not approved for any indication.
BGB-DXP604 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company sponsored the Phase 1 trial of the compound.
BGB-DXP604 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved for any use.
BGB-DXP604 has been evaluated in a single Phase 1 trial, NCT04669262, titled "BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants." The trial was completed and enrolled 25 healthy volunteers in Australia.
The Phase 1 trial NCT04669262 was a randomized, double-blind, controlled study of BGB-DXP604 alone and in combination with BGB-DXP593. It enrolled 25 healthy participants aged 18 years and older in Australia and has been completed.