Clinical trial NCT04532294: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the day of study drug administration until 30 days after dose (up to approximately 160 days)
Secondary outcomes:
measure: Number of Participants With Clinically Relevant Changes in Vital Signs and Electrocardiograms
timeFrame: Up to approximately 160 days
measure: Number of Participants With Clinically Relevant Changes in Laboratory Parameters
timeFrame: Up to approximately 160 days
measure: Maximum Observed Plasma Concentration (Cmax) of BGB-DXP593
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)
measure: Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of BGB-DXP593
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)
measure: AUC From Time Zero to Time of Last Quantifiable Concentration (AUClast) of BGB-DXP593
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)
measure: AUC From Time Zero to Day 29 (AUC0-29) of BGB-DXP593
timeFrame: Day 1 (pre-dose, End of Infusion, 6 hrs. post-dose), Days 2, 3, 4, 5, 8, 15, 22, and 29
measure: Time to Maximum Observed Plasma Concentration (Tmax) of BGB-DXP593
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)
measure: Terminal Half Life (t1/2) of BGB-DXP593
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)
measure: Clearance (CL) of BGB-DXP593
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)
measure: Volume of Distribution (Vz) of BGB-DXP593
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)
measure: Immunogenic Response to BGB-DXP593 as Assessed by the Detection of Antidrug Antibodies (ADA)
timeFrame: Up to approximately160 days
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q PHARM
state: Queensland
Study officials:
affiliation: BeiGene
name: Study Director
role: PRINCIPAL_INVESTIGATOR
References:
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.