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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04551898 | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19) | PHASE2 | COMPLETED | 181 | — | — | Dec 2, 2020 | May 25, 2021 | Oct 26, 2024 | 18 | United States, Brazil +2 |
| NCT04532294 | Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants | PHASE1 | COMPLETED | 18 | — | — | Sep 8, 2020 | Feb 13, 2021 | Oct 26, 2024 | 1 | Australia |
SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
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
| Arm | Type | Description |
|---|---|---|
| BGB-DXP593 Low Dose | EXPERIMENTAL | Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days |
| BGB-DXP593 Medium Dose | EXPERIMENTAL | Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days |
| BGB-DXP593 High Dose | EXPERIMENTAL | Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo on Day 1, and followed up for safety for up to 85 days |
| BGB-DXP593: Dose Level A | EXPERIMENTAL | Participants will receive BGB-DXP593 10 mg/kg on Day 1 |
| BGB-DXP593: Dose Level B | EXPERIMENTAL | Participants will receive BGB-DXP593 30 mg/kg on Day 1 |
| Name | Type | Description |
|---|---|---|
| BGB-DXP593 | DRUG | Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm |
| Placebo | DRUG | Placebo to match BGB-DXP593 administered as specified in the treatment arm |
| BGB DXP593 | DRUG | Administered intravenously (IV) as specified in the treatment arm |
Key Inclusion Criteria: 1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection (positive reverse transcription-polymerase chain reaction \[RT-PCR\] test or other authorized antigen testing methods) in any samples following local practice ≤ 72 hours prior to screening. 2. H...