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Trials / Completed

CompletedNCT04532294

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
18 (actual)
Sponsor
BeiGene · Industry
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DRUGBGB DXP593Administered intravenously (IV) as specified in the treatment arm
DRUGPlaceboPlacebo to match BGB-DXP593

Timeline

Start date
2020-09-08
Primary completion
2021-02-13
Completion
2021-02-13
First posted
2020-08-31
Last updated
2024-10-26
Results posted
2022-01-27

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT04532294. Inclusion in this directory is not an endorsement.

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV- (NCT04532294) · Clinical Trials Directory