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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04669262 | BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants | PHASE1 | COMPLETED | 25 | — | — | Dec 9, 2020 | May 21, 2021 | Oct 26, 2024 | 1 | Australia |
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...