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The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGB-DXP593: Dose Level A | Experimental | Participants will receive BGB-DXP593 10 mg/kg on Day 1 |
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| BGB-DXP593: Dose Level B | Experimental | Participants will receive BGB-DXP593 30 mg/kg on Day 1 |
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| Placebo | Experimental | Placebo to match (PTM) BGB-DXP593 on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB DXP593 | Drug | Administered intravenously (IV) as specified in the treatment arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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 | From the day of study drug administration until 30 days after dose (up to approximately 160 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms | Systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate were measured. Descriptive statistics for ECG parameters (heart rate and QTcF interval) and changes from baseline were summarized | Up to approximately 160 days |
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Key Inclusion Criteria :
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | BeiGene | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q PHARM | Herston | Queensland | 4006 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received a single intravenous dose of matching placebo |
| FG001 | BGB-DXP593 10 mg/kg | Participants received a single 10 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2020 | Jan 19, 2022 |
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| Placebo | Drug | Placebo to match BGB-DXP593 |
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| Number of Participants With Clinically Relevant Changes in Laboratory Parameters | Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology, serum chemistry and urinalysis. | Up to approximately 160 days |
| Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
| AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
| AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, and 29 |
| Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
| Terminal Half Life (t1/2) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
| Clearance (CL) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
| Volume of Distribution (Vz) of BGB-DXP593 | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
| Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA) | Up to approximately160 days |
| FG002 | BGB-DXP593 30 mg/kg | Participants received a single 30 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593 |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set (SAS) : Includes all participants who received the study drug or placebo
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received a single intravenous dose of matching placebo |
| BG001 | BGB-DXP593 10 mg/kg | Participants received a single 10 mg/kg intravenous dose of BGB-DXP593 |
| BG002 | BGB-DXP593 30 mg/kg | Participants received a single 30 mg/kg intravenous dose of BGB-DXP593 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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 | Safety analysis set | Posted | Count of Participants | Participants | From the day of study drug administration until 30 days after dose (up to approximately 160 days) |
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| Secondary | Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms | Systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate were measured. Descriptive statistics for ECG parameters (heart rate and QTcF interval) and changes from baseline were summarized | Safety analysis set | Posted | Count of Participants | Participants | Up to approximately 160 days |
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| Secondary | Number of Participants With Clinically Relevant Changes in Laboratory Parameters | Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology, serum chemistry and urinalysis. | Safety analysis set | Posted | Count of Participants | Participants | Up to approximately 160 days |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 | Pharmacokinetic (PK) Analysis Set includes all the participants who received the study drug and had any measurable concentration of study drug. | Posted | Median | Full Range | μg/mL | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
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| Secondary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | day*μg/mL | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
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| Secondary | AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | day*μg/mL | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
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| Secondary | AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | day*μg/mL | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, and 29 |
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| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | hours | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
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| Secondary | Terminal Half Life (t1/2) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | Day | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
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| Secondary | Clearance (CL) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | Liters/Day | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
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| Secondary | Volume of Distribution (Vz) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | Liters | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) |
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| Secondary | Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA) | The ADA Analysis Set includes all the participants who received the study drug and in whom both baseline ADA and at least 1 postbaseline ADA results are available | Posted | Count of Participants | Participants | Up to approximately160 days |
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From the day of study drug administration until 30 days after dose (Up to approximately160 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received a single intravenous dose of matching placebo | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | BGB-DXP593 10 mg/kg | Participants received a single 10 mg/kg intravenous dose of BGB-DXP593 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG002 | BGB-DXP593 30 mg/kg | Participants received a single 30 mg/kg intravenous dose of BGB-DXP593 | 0 | 6 | 0 | 6 | 4 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA) Version 24.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA) Version 24.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA) Version 24.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 24.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA) Version 24.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Intermenstrual bleeding | Reproductive system and breast disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA) Version 24.0 | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 24.0 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA Version 24.0 | Systematic Assessment |
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BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information & may request a further delay to protect its IP rights
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2021 | Jan 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| White |
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| Other |
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