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

Phase 1

Completed

• Conditions: Covid19
• Interventions: Drug: Placebo; Drug: BGB DXP593

• Registration Number: NCT04532294
• Lead Sponsor: BeiGene

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-08-27
• Study First Posted: 2020-08-31
• Study Start: 2020-09-08
• Primary Completion: 2021-02-13
• Study Completion: 2021-02-13
• Results First Submitted: 2022-01-19
• Results First Submitted QC: 2022-01-19
• Results First Posted: 2022-01-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk to the participant when taking the study drug; or interfering with the interpretation of data
2. Any history of a severe allergic reaction prior to enrollment that has a reasonable risk of recurrence during the study
3. Have a medical history of SARS infection
4. Any acute fever disease or infections
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to match (PTM) BGB-DXP593 on Day 1
BGB-DXP593: Dose Level A	BGB DXP593	Participants will receive BGB-DXP593 10 mg/kg on Day 1
BGB-DXP593: Dose Level B	BGB DXP593	Participants will receive BGB-DXP593 30 mg/kg on Day 1

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	From the day of study drug administration until 30 days after dose (up to approximately 160 days)	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

Name	Time	Method
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)
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)
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 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
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)
Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)	Up to approximately160 days
Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms	Up to approximately 160 days	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
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)
Number of Participants With Clinically Relevant Changes in Laboratory Parameters	Up to approximately 160 days	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	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)
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)

Trial Locations

Locations (1)

Q PHARM; 🇦🇺 Herston, Queensland, Australia