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
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

Completed
COVID19

Drug: BGB DXP593

Administered intravenously (IV) as specified in the treatment arm

Drug: Placebo

Placebo to match BGB-DXP593

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
Australia
Locations

Q Pharm Pty Limited
Herston, Queensland, Australia

Study Director, Principal Investigator
BeiGene

NCT Number
MeSH Terms
COVID-19