Trial Outcomes & Findings for BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants (NCT NCT04669262)
NCT ID: NCT04669262
Last Updated: 2024-10-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
From the day of study drug administration until 30 days after the dose (approximately day 113 )
Results posted on
2024-10-26
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 milligram/kilogram (mg/kg) BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 milligram/kilogram (mg/kg) BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Overall Study
Randomized but Not Treated
|
0
|
1
|
0
|
0
|
Baseline Characteristics
BGB-DXP604 Alone and in Combination With BGB-DXP593 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg
n=6 Participants
Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 12.79 • n=5 Participants
|
28.8 years
STANDARD_DEVIATION 15.30 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 11.82 • n=4 Participants
|
30.0 years
STANDARD_DEVIATION 11.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From the day of study drug administration until 30 days after the dose (approximately day 113 )Population: Safety Analysis Set
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.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg
n=6 Participants
Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Participants with at least 1 TEAE
|
5 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
Grade 4 or Higher
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the day of study drug administration until 30 days after the dose (approximately day 113)Population: Safety analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg
n=6 Participants
Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604
|
|---|---|---|---|---|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
Vital Signs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
Laboratory Parameters
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Meaningful Changes in Vital Signs, 12-Lead ECG Parameters and Laboratory Findings
12-Lead ECG Parameters
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of BGB-DXP593
|
413.4 μg/mL
Standard Deviation 52.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: Pharmacokinetic (PK) Analysis Set included all the participants who received either study drug and had any measurable concentration of study drug(s).
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of BGB-DXP604
|
236.9 μg/mL
Standard Deviation 38.20
|
744.4 μg/mL
Standard Deviation 165.32
|
376.7 μg/mL
Standard Deviation 71.14
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
|
7282.4 day*μg/mL
Interval 6329.0 to 8863.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP604
|
5332.3 day*μg/mL
Interval 4712.0 to 6456.0
|
15999.4 day*μg/mL
Interval 13309.0 to 22670.0
|
8850.6 day*μg/mL
Interval 7227.0 to 10970.0
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
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
Interval 6466.0 to 9169.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
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
Interval 4984.0 to 6979.0
|
17284.1 day*μg/mL
Interval 14410.0 to 25171.0
|
9756.2 day*μg/mL
Interval 8369.0 to 12882.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP593
|
4638.0 day*μg/mL
Interval 3964.0 to 5227.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 Pre-dose, end of infusion, 6 hours post dose, Days 2,3,4,5,8,15,22, and 29Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Area Under the Concentration Time Curve From Day 1 to Day 29 (AUC0-29) of BGB-DXP604
|
2838.6 day*μg/mL
Interval 2417.0 to 3533.0
|
8282.9 day*μg/mL
Interval 6811.0 to 11562.0
|
4692.8 day*μg/mL
Interval 4058.0 to 5754.0
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Time to Achieve Maximum Observed Concentration (Tmax) of BGB-DXP593
|
2.93 hours
Interval 2.8 to 8.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Time to Achieve Maximum Observed Serum Concentration (Tmax) of BGB-DXP604
|
1.183 hours
Interval 0.97 to 1.25
|
1.167 hours
Interval 1.167 to 6.97
|
1.275 hours
Interval 1.02 to 25.07
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Half-life Time (t1/2) of BGB-DXP593
|
20.96 day
Interval 19.2 to 22.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Half-life Time (t1/2) of BGB-DXP604
|
31.46 day
Interval 27.3 to 35.6
|
30.56 day
Interval 27.6 to 33.9
|
32.03 day
Interval 29.1 to 41.8
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Clearance (CL) of BGB-DXP593
|
0.15 Liters/day
Interval 0.1 to 0.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Clearance (CL) of BGB-DXP604
|
0.11 Liters/day
Interval 0.1 to 0.13
|
0.11 Liters/day
Interval 0.1 to 0.2
|
0.11 Liters/day
Interval 0.1 to 0.2
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Volume of Distribution (Vz) of BGB-DXP593
|
4.59 Liters
Interval 4.1 to 5.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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/EOSPopulation: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Volume of Distribution (Vz) of BGB-DXP604
|
5.00 Liters
Interval 4.9 to 5.7
|
4.78 Liters
Interval 3.8 to 7.7
|
5.55 Liters
Interval 4.6 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and Days 15,29,57,85 and 113/EOS visitPopulation: 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
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 Participants
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 Participants
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
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
|
|---|---|---|---|---|
|
Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593
Treatment Induced
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
|
Clinical Immunogenicity: Number of Participants With Anti-drug Antibodies to BGB-DXP604 and BGB-DXP593
Treatment Emergent
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BGB-DXP604 10 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BGB-DXP604 30 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Participants received normal saline intravenously as placebo at the same volume as BGB-DXP593 or BGB-DXP604
|
BGB-DXP604 10 mg/kg
n=6 participants at risk
Participants received a single intravenous dose of 10 mg/kg BGB-DXP604
|
BGB-DXP604 30 mg/kg
n=6 participants at risk
Participants received a single intravenous dose of 30 mg/kg BGB-DXP604
|
BGB-DXP593 15 mg/kg + BGB-DXP604 15 mg/kg
n=6 participants at risk
Participants received a single intravenous dose of 15mg/kg of BGB-DXP593 followed by a single intravenous dose of 15mg/kg of BGB-DXP604
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
2/6 • 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.
|
33.3%
2/6 • 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.
|
16.7%
1/6 • 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.
|
50.0%
3/6 • 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.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
General disorders
Catheter site swelling
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
General disorders
Malaise
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
16.7%
1/6 • 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.
|
16.7%
1/6 • 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.
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 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.
|
0.00%
0/6 • 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.
|
16.7%
1/6 • 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.
|
33.3%
2/6 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER