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The primary objective of this study is to investigate the safety and tolerability of BGB-DXP604 alone and in combination with BGB-DXP593 in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-DXP604 | Drug | Administered as intravenous (IV) infusion over 30 to 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent 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. 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. | From the day of study drug administration until 30 days after the dose (approximately day 113 ) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | From the day of study drug administration until 30 days after the dose (approximately day 113) | |
| Maximum Observed Serum Concentration (Cmax) of BGB-DXP593 |
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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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q PHARM | Herston | Queensland | 4006 | Australia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604 |
| FG001 | BGB-DXP604 10 mg/kg | Participants received a single intravenous dose of 10 milligram/kilogram (mg/kg) BGB-DXP604 |
| FG002 | BGB-DXP604 30 mg/kg | Participants received a single intravenous dose of 30 mg/kg BGB-DXP604 |
| FG003 | BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set is defined as all the participants who received either study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604 |
| BG001 | BGB-DXP604 10 mg/kg | Participants received a single intravenous dose of 10 mg/kg BGB-DXP604 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent 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. 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. | Safety Analysis Set | Posted | Count of Participants | Participants | From the day of study drug administration until 30 days after the dose (approximately day 113 ) |
|
From the day of study drug administration until 30 days after the dose (approximately Day 113)
Safety Analysis Set. A TEAE is defined as an 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.
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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 normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
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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 | Nov 23, 2020 | Mar 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2021 | Mar 29, 2022 | SAP_001.pdf |
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| BGB-DXP593 | Drug | Administered as intravenous (IV) infusion over 30 to 60 minutes |
|
| Placebo | Drug | Placebo to match BGB-DXP593 |
|
| Placebo | Drug | Placebo to match BGB-DXP604 |
|
| Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/End of Study (EOS) |
| Maximum Observed Serum Concentration (Cmax) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29 |
| Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29 |
| Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Half-life Time (t1/2) of BGB-DXP593 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Half-life Time (t1/2) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Clearance (CL) of BGB-DXP593 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Clearance (CL) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Volume of Distribution (Vz) of BGB-DXP593 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Volume of Distribution (Vz) of BGB-DXP604 | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
| Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Pre-dose and Days 15,29,57,85 and 113/EOS visit |
| Randomized but Not Treated |
|
| BG002 | BGB-DXP604 30 mg/kg | Participants received a single intravenous dose of 30 mg/kg BGB-DXP604 |
| BG003 | BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | BGB-DXP604 10 mg/kg | Participants received a single intravenous dose of 10 mg/kg BGB-DXP604 |
| OG002 | BGB-DXP604 30 mg/kg | Participants received a single intravenous dose of 30 mg/kg BGB-DXP604 |
| OG003 | BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604 |
|
|
| Secondary | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Safety analysis Set | Posted | Number | participants | From the day of study drug administration until 30 days after the dose (approximately day 113) |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of BGB-DXP593 | PK Analysis Set | Posted | Mean | Standard Deviation | μg/mL | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/End of Study (EOS) |
|
|
|
| Secondary | Maximum Observed Serum Concentration (Cmax) of BGB-DXP604 | Pharmacokinetic (PK) Analysis Set included all the participants who received either study drug and had any measurable concentration of study drug(s). | Posted | Mean | Standard Deviation | μg/mL | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Area Under the Concentration Time Curve 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 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604 | PK Analysis Set | Posted | Median | Full Range | day*μg/mL | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | day*μg/mL | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604 | PK Analysis Set | Posted | Median | Full Range | day*μg/mL | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Area Under the Concentration Time Curve From Day 1 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 hours post dose, Days 2,3,4,5,8,15,22, and 29 |
|
|
|
| Secondary | Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604 | PK Analysis Set | Posted | Median | Full Range | day*μg/mL | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29 |
|
|
|
| Secondary | Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | hours | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604 | PK Analysis Set | Posted | Median | Full Range | hours | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Half-life Time (t1/2) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | day | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Half-life Time (t1/2) of BGB-DXP604 | PK Analysis Set | Posted | Median | Full Range | day | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Clearance (CL) of BGB-DXP593 | PK Analysis Set | Posted | Median | Full Range | Liters/day | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Clearance (CL) of BGB-DXP604 | PK Analysis Set | Posted | Median | Full Range | Liters/day | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Volume of Distribution (Vz) of BGB-DXP593 | PK analysis Set | Posted | Median | Full Range | Liters | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Volume of Distribution (Vz) of BGB-DXP604 | PK Analysis Set | Posted | Median | Full Range | Liters | Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22,29,43,57,71,85 and 113/EOS |
|
|
|
| Secondary | Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Anti-drug antibody (ADA) Analysis Set includes all participants who received either study drug and for whom both baseline ADA and ≥ 1 postbaseline ADA results are available | Posted | Number | Percentage of participants | Pre-dose and Days 15,29,57,85 and 113/EOS visit |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | BGB-DXP604 10 mg/kg | Participants received a single intravenous dose of 10 mg/kg BGB-DXP604 | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | BGB-DXP604 30 mg/kg | Participants received a single intravenous dose of 30 mg/kg BGB-DXP604 | 0 | 6 | 0 | 6 | 5 | 6 |
| EG003 | BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604 | 0 | 6 | 0 | 6 | 6 | 6 |
| Paraesthesia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
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.
| Laboratory Parameters |
|
| 12-Lead ECG Parameters |
|
| Title | Measurements |
|---|---|
|