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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04532294
• Other study ID #: BGB-DXP593-101
• Status: Completed
• Phase: Phase 1
• Start date: September 8, 2020
• Est. completion date: February 13, 2021

Study information

• Verified date: January 2022
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 13, 2021
• Est. primary completion date: February 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Key Inclusion Criteria :

1. 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

2. Body weight = 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive) Note: BMI = weight [kg] / (height [m])

3. Negative serum IgG to the SARS-CoV-2

4. 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:

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• BGB DXP593
Administered intravenously (IV) as specified in the treatment arm
• Placebo
Placebo to match BGB-DXP593

Locations

Country	Name	City	State
Australia	Q Pharm Pty Limited	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)		Up to approximately160 days