Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants (NCT NCT04532294)
NCT ID: NCT04532294
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
From the day of study drug administration until 30 days after dose (up to approximately 160 days)
Results posted on
2024-10-26
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
Participants received a single 10 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
8
|
|
Overall Study
COMPLETED
|
4
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
Participants received a single 10 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 milligrams/kilogram (mg/kg) intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Participants Not Dosed
|
0
|
0
|
2
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
n=6 Participants
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 16.46 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 14.81 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 14.62 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 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
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the day of study drug administration until 30 days after dose (up to approximately 160 days)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
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
n=6 Participants
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with at least 1 TEAE
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 160 daysPopulation: Safety analysis set
Systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate were measured. Descriptive statistics for ECG parameters (heart rate and QTcF interval) and changes from baseline were summarized
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
n=6 Participants
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms
Participants with changes in vital signs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms
Participants with changes in ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 160 daysPopulation: Safety analysis set
Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology, serum chemistry and urinalysis.
Outcome measures
| Measure |
Placebo
n=4 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
n=6 Participants
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in Laboratory Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)Population: Pharmacokinetic (PK) Analysis Set includes all the participants who received the study drug and had any measurable concentration of study drug.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
|
255.3 μg/mL
Interval 213.0 to 328.0
|
667.0 μg/mL
Interval 511.0 to 787.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593
|
4168.8 day*μg/mL
Interval 3565.0 to 6188.0
|
12422.6 day*μg/mL
Interval 9095.0 to 15810.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
|
3964.6 day*μg/mL
Interval 3388.0 to 5887.0
|
11434.2 day*μg/mL
Interval 8912.0 to 15334.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, and 29Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593
|
2368.4 day*μg/mL
Interval 2052.0 to 3489.0
|
6683.9 day*μg/mL
Interval 5919.0 to 9022.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593
|
1.47 hours
Interval 1.3 to 7.0
|
3.67 hours
Interval 1.2 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Terminal Half Life (t1/2) of BGB-DXP593
|
26.60 Day
Interval 20.4 to 32.1
|
25.77 Day
Interval 20.7 to 29.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Clearance (CL) of BGB-DXP593
|
0.18 Liters/Day
Interval 0.1 to 0.2
|
0.19 Liters/Day
Interval 0.1 to 0.2
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days)Population: PK Analysis Set
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Volume of Distribution (Vz) of BGB-DXP593
|
6.54 Liters
Interval 3.1 to 8.1
|
6.30 Liters
Interval 5.7 to 9.4
|
—
|
SECONDARY outcome
Timeframe: Up to approximately160 daysPopulation: The ADA Analysis Set includes all the participants who received the study drug and in whom both baseline ADA and at least 1 postbaseline ADA results are available
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 Participants
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)
Treatment Induced ADA
|
1 Participants
|
0 Participants
|
—
|
|
Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)
Neutralizing antibody (NAb) Positive
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BGB-DXP593 10 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BGB-DXP593 30 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Participants received a single intravenous dose of matching placebo
|
BGB-DXP593 10 mg/kg
n=6 participants at risk
Participants received a single 10 mg/kg intravenous dose of BGB-DXP593
|
BGB-DXP593 30 mg/kg
n=6 participants at risk
Participants received a single 30 mg/kg intravenous dose of BGB-DXP593
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
50.0%
2/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
33.3%
2/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
33.3%
2/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Nervous system disorders
Presyncope
|
25.0%
1/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
General disorders
Catheter site pain
|
25.0%
1/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
33.3%
2/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
General disorders
Catheter site swelling
|
0.00%
0/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
16.7%
1/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
16.7%
1/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
16.7%
1/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
33.3%
2/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
16.7%
1/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
16.7%
1/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
|
General disorders
Catheter site bruise
|
0.00%
0/4 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
0.00%
0/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
16.7%
1/6 • From the day of study drug administration until 30 days after dose (Up to approximately160 days)
|
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