Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants

Study Overview
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Brief Summary
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The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593 administered intravenously as a single dose in healthy participants

Official Title
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A First-in-Human, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of SARS-CoV-2 Neutralizing Antibody BGB-DXP593 in Healthy Subjects

Conditions
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Covid19

Intervention / Treatment
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* Drug: BGB DXP593
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria : 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 Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive) Note: BMI = weight [kg] / (height [m]) Negative serum IgG to the SARS-CoV-2 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: 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 taking the study drug; or interfering with the interpretation of data Any history of a severe allergic reaction prior to enrollment that has a reasonable risk of recurrence during the study Have a medical history of SARS infection Any acute fever disease or infections 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: diabetes mellitus type I, chronic hepatitis; or clinically significant forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune disease, psychiatric disorders, or heart disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGB-DXP593: Dose Level A<br>Participants will receive BGB-DXP593 10 mg/kg on Day 1 | Drug: BGB DXP593<br>* Administered intravenously (IV) as specified in the treatment arm<br>|
| Experimental: BGB-DXP593: Dose Level B<br>Participants will receive BGB-DXP593 30 mg/kg on Day 1 | Drug: BGB DXP593<br>* Administered intravenously (IV) as specified in the treatment arm<br>|
| Experimental: Placebo<br>Placebo to match (PTM) BGB-DXP593 on Day 1 | Drug: Placebo<br>* Placebo to match BGB-DXP593<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | A TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline on or after the administration of study drug and up to 30 days after the dose of study drug | From the day of study drug administration until 30 days after dose (up to approximately 160 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms | Systolic and diastolic blood pressure, pulse rate, body temperature, and respiratory rate were measured. Descriptive statistics for ECG parameters (heart rate and QTcF interval) and changes from baseline were summarized | Up to approximately 160 days | 
| Number of Participants With Clinically Relevant Changes in Laboratory Parameters | Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology, serum chemistry and urinalysis. | Up to approximately 160 days | 
| Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) | 
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) | 
| AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) | 
| AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, and 29 | 
| Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) | 
| Terminal Half Life (t1/2) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) | 
| Clearance (CL) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) | 
| Volume of Distribution (Vz) of BGB-DXP593 |  | Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71, 85 and End of study visit (Up to approximately160 days) | 
| Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA) |  | Up to approximately160 days |