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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

BGB DXP593

Placebo

About this trial

This is an interventional basic science trial for Covid19

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Q Pharm Pty Limited

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

BGB-DXP593: Dose Level A

BGB-DXP593: Dose Level B

Placebo

Arm Description

Participants will receive BGB-DXP593 10 mg/kg on Day 1

Participants will receive BGB-DXP593 30 mg/kg on Day 1

Placebo to match (PTM) BGB-DXP593 on Day 1

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593

AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593

AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593

Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593

Terminal Half Life (t1/2) of BGB-DXP593

Clearance (CL) of BGB-DXP593

Volume of Distribution (Vz) of BGB-DXP593

Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)

Full Information

NCT ID

NCT04532294

First Posted

August 27, 2020

Last Updated

January 19, 2022

Sponsor

BeiGene

1. Study Identification

Unique Protocol Identification Number

NCT04532294

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

February 13, 2021 (Actual)

Study Completion Date

February 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BGB-DXP593: Dose Level A

Arm Type

Experimental

Arm Description

Participants will receive BGB-DXP593 10 mg/kg on Day 1

Arm Title

BGB-DXP593: Dose Level B

Arm Type

Experimental

Arm Description

Participants will receive BGB-DXP593 30 mg/kg on Day 1

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Placebo to match (PTM) BGB-DXP593 on Day 1

Intervention Type

Drug

Intervention Name(s)

BGB DXP593

Intervention Description

Administered intravenously (IV) as specified in the treatment arm

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match BGB-DXP593

Primary Outcome Measure Information:

Title

Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Description

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

Time Frame

From the day of study drug administration until 30 days after dose (up to approximately 160 days)

Secondary Outcome Measure Information:

Title

Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms

Description

Time Frame

Up to approximately 160 days

Title

Number of Participants With Clinically Relevant Changes in Laboratory Parameters

Description

Clinical laboratory values were evaluated for each laboratory parameter as applicable including hematology, serum chemistry and urinalysis.

Time Frame

Up to approximately 160 days

Title

Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593

Time Frame

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)

Title

Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593

Time Frame

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)

Title

AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593

Time Frame

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)

Title

AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593

Time Frame

Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, and 29

Title

Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593

Time Frame

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)

Title

Terminal Half Life (t1/2) of BGB-DXP593

Time Frame

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)

Title

Clearance (CL) of BGB-DXP593

Time Frame

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)

Title

Volume of Distribution (Vz) of BGB-DXP593

Time Frame

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)

Title

Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)

Time Frame

Up to approximately160 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Director

Organizational Affiliation

BeiGene

Official's Role

Principal Investigator

Facility Information:

Facility Name

Q Pharm Pty Limited

City

Herston

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

34473343

Citation

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Results Reference

derived

Learn more about this trial

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

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