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 being developed by BeOne Medicines Ltd. (ticker: ONC). It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other. It is not approved and remains in clinical investigation.
BGB-DXP604 is being studied for use in healthy participants, as part of early-phase clinical development. The completed Phase 1 trial evaluated the drug alone and in combination with BGB-DXP593 in healthy volunteers. Its intended therapeutic use has not been established, as it is still in clinical trials.
BGB-DXP604 is developed by BeOne Medicines Ltd., a biopharmaceutical company listed under the ticker ONC. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational small molecule in healthy participants.
BGB-DXP604 is in Phase 1 clinical development. A Phase 1 trial has been completed, involving 25 healthy participants. The drug is investigational and has not been approved by regulatory authorities. Further clinical development may be required to assess its safety and efficacy.
BGB-DXP604 has been studied in one completed Phase 1 trial, NCT04669262, titled 'BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants.' This randomized, double-blind, controlled trial enrolled 25 healthy volunteers in Australia, with participants aged 18 years and older.
No, BGB-DXP604 is not the same as BGB-DXP593. They are distinct investigational drugs. In the completed Phase 1 trial NCT04669262, BGB-DXP604 was evaluated both alone and in combination with BGB-DXP593 in healthy participants. The trial was designed to assess the safety and tolerability of these agents.