Healthy
Conditions
Brief summary
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
Interventions
DRUGBGB-DXP604
Administered as intravenous (IV) infusion over 30 to 60 minutes
DRUGBGB-DXP593
Administered as intravenous (IV) infusion over 30 to 60 minutes
DRUGPlacebo
Placebo to match BGB-DXP593
Sponsors
BeiGene
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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 (BMI) within the range 18 to 32 kg/m\^2 (inclusive) 3. Negative SARS-CoV-2 serology test 4. Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the method of real-time reverse transcription-polymerase chain reaction (rRT-PCR) Key
Exclusion criteria
1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when receiving the study drug; or interfering with the interpretation of data 2. Any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that has been resected with no evidence of metastatic disease for 3 years 3. Any history of a severe allergic reaction before enrollment that has a reasonable risk of recurrence during the study 4. Any chronic or clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant, including but not limited to type 1 diabetes mellitus, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease 5. Previous receipt of a licensed or investigational biologic agent (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before the randomization NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | From the day of study drug administration until 30 days after the dose (approximately day 113 ) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Maximum Observed Serum Concentration (Cmax) 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/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 |
| 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) |
| 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 |
| 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 |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604 | 6 |
| BGB-DXP604 10 mg/kg Participants received a single intravenous dose of 10 mg/kg BGB-DXP604 | 6 |
| BGB-DXP604 30 mg/kg Participants received a single intravenous dose of 30 mg/kg BGB-DXP604 | 6 |
| 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 | 6 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Randomized but Not Treated | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | BGB-DXP604 30 mg/kg | BGB-DXP604 10 mg/kg |
|---|---|---|---|---|---|
| Age, Continuous | 27.3 years STANDARD_DEVIATION 12.79 | 30.0 years STANDARD_DEVIATION 11.46 | 32.2 years STANDARD_DEVIATION 11.82 | 31.5 years STANDARD_DEVIATION 6.98 | 28.8 years STANDARD_DEVIATION 15.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 23 Participants | 5 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 21 Participants | 6 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 13 Participants | 3 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 11 Participants | 3 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 5 / 6 | 3 / 6 | 5 / 6 | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: From the day of study drug administration until 30 days after the dose (approximately day 113 )
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Participants with at least 1 TEAE | 5 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 3 | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 4 or Higher | 0 Participants |
| Placebo | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAE | 0 Participants |
| BGB-DXP604 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 3 | 0 Participants |
| BGB-DXP604 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 4 or Higher | 0 Participants |
| BGB-DXP604 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAE | 0 Participants |
| BGB-DXP604 10 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Participants with at least 1 TEAE | 3 Participants |
| BGB-DXP604 30 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 4 or Higher | 0 Participants |
| BGB-DXP604 30 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 3 | 0 Participants |
| BGB-DXP604 30 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAE | 0 Participants |
| BGB-DXP604 30 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Participants with at least 1 TEAE | 5 Participants |
| BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | SAE | 0 Participants |
| BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 3 | 0 Participants |
| BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Participants with at least 1 TEAE | 6 Participants |
| BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs) | Grade 4 or Higher | 0 Participants |
Secondary
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593 | 4638.0 day*μg/mL |
Secondary
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604
Time frame: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604 | 2838.6 day*μg/mL |
| BGB-DXP604 10 mg/kg | Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604 | 8282.9 day*μg/mL |
| BGB-DXP604 30 mg/kg | Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604 | 4692.8 day*μg/mL |
Secondary
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593 | 7282.4 day*μg/mL |
Secondary
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604 | 5332.3 day*μg/mL |
| BGB-DXP604 10 mg/kg | Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604 | 15999.4 day*μg/mL |
| BGB-DXP604 30 mg/kg | Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604 | 8850.6 day*μg/mL |
Secondary
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase(AUCinf) of BGB-DXP593 | 7445.4 day*μg/mL |
Secondary
Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604 | 5801.2 day*μg/mL |
| BGB-DXP604 10 mg/kg | Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604 | 17284.1 day*μg/mL |
| BGB-DXP604 30 mg/kg | Area Under the Concentration Time Curve From Zero to Infinite Time With Extrapolation of the Terminal Phase (AUCinf) of BGB-DXP604 | 9756.2 day*μg/mL |
Secondary
Clearance (CL) of BGB-DXP593
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Clearance (CL) of BGB-DXP593 | 0.15 Liters/day |
Secondary
Clearance (CL) of BGB-DXP604
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Clearance (CL) of BGB-DXP604 | 0.11 Liters/day |
| BGB-DXP604 10 mg/kg | Clearance (CL) of BGB-DXP604 | 0.11 Liters/day |
| BGB-DXP604 30 mg/kg | Clearance (CL) of BGB-DXP604 | 0.11 Liters/day |
Secondary
Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593
Time frame: Pre-dose and Days 15,29,57,85 and 113/EOS visit
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Treatment Induced | 0 Percentage of participants |
| Placebo | Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Treatment Emergent | 0 Percentage of participants |
| BGB-DXP604 10 mg/kg | Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Treatment Induced | 0 Percentage of participants |
| BGB-DXP604 10 mg/kg | Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Treatment Emergent | 0 Percentage of participants |
| BGB-DXP604 30 mg/kg | Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Treatment Emergent | 0 Percentage of participants |
| BGB-DXP604 30 mg/kg | Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593 | Treatment Induced | 0 Percentage of participants |
Secondary
Half-life Time (t1/2) of BGB-DXP593
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Half-life Time (t1/2) of BGB-DXP593 | 20.96 day |
Secondary
Half-life Time (t1/2) of BGB-DXP604
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Half-life Time (t1/2) of BGB-DXP604 | 31.46 day |
| BGB-DXP604 10 mg/kg | Half-life Time (t1/2) of BGB-DXP604 | 30.56 day |
| BGB-DXP604 30 mg/kg | Half-life Time (t1/2) of BGB-DXP604 | 32.03 day |
Secondary
Maximum Observed Serum Concentration (Cmax) of BGB-DXP593
Time frame: 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)
Population: PK Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax) of BGB-DXP593 | 413.4 μg/mL | Standard Deviation 52.47 |
Secondary
Maximum Observed Serum Concentration (Cmax) of BGB-DXP604
Time frame: 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
Population: Pharmacokinetic (PK) Analysis Set included all the participants who received either study drug and had any measurable concentration of study drug(s).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Maximum Observed Serum Concentration (Cmax) of BGB-DXP604 | 236.9 μg/mL | Standard Deviation 38.2 |
| BGB-DXP604 10 mg/kg | Maximum Observed Serum Concentration (Cmax) of BGB-DXP604 | 744.4 μg/mL | Standard Deviation 165.32 |
| BGB-DXP604 30 mg/kg | Maximum Observed Serum Concentration (Cmax) of BGB-DXP604 | 376.7 μg/mL | Standard Deviation 71.14 |
Secondary
Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
Time frame: From the day of study drug administration until 30 days after the dose (approximately day 113)
Population: Safety analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | 12-Lead ECG Parameters | 0 participants |
| Placebo | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Laboratory Parameters | 0 participants |
| Placebo | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Vital Signs | 0 participants |
| BGB-DXP604 10 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Laboratory Parameters | 0 participants |
| BGB-DXP604 10 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | 12-Lead ECG Parameters | 0 participants |
| BGB-DXP604 10 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Vital Signs | 0 participants |
| BGB-DXP604 30 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Vital Signs | 0 participants |
| BGB-DXP604 30 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Laboratory Parameters | 0 participants |
| BGB-DXP604 30 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | 12-Lead ECG Parameters | 0 participants |
| BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | 12-Lead ECG Parameters | 0 participants |
| BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Vital Signs | 0 participants |
| BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg | Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings | Laboratory Parameters | 0 participants |
Secondary
Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593 | 2.93 hours |
Secondary
Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604 | 1.183 hours |
| BGB-DXP604 10 mg/kg | Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604 | 1.167 hours |
| BGB-DXP604 30 mg/kg | Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604 | 1.275 hours |
Secondary
Volume of Distribution (Vz) of BGB-DXP593
Time frame: 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
Population: PK analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Volume of Distribution (Vz) of BGB-DXP593 | 4.59 Liters |
Secondary
Volume of Distribution (Vz) of BGB-DXP604
Time frame: 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
Population: PK Analysis Set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Volume of Distribution (Vz) of BGB-DXP604 | 5.00 Liters |
| BGB-DXP604 10 mg/kg | Volume of Distribution (Vz) of BGB-DXP604 | 4.78 Liters |
| BGB-DXP604 30 mg/kg | Volume of Distribution (Vz) of BGB-DXP604 | 5.55 Liters |