Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04441918
Status:
UNKNOWN
Last Update Posted:
2020-06-22
First Post:
2020-06-06
Brief Title:
TolerabilitySafetyPharmacokinetic Profile and Immunogenicity of a Recombinant Humanized Anti-SARS-CoV-2 Monoclonal Antibody JS016 for Injection in Chinese Health Subjects
Sponsor:
Shanghai Junshi Bioscience Co Ltd
Organization:
Shanghai Junshi Bioscience Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability Safety Pharmacokinetic Profile and Immunogenicity of JS016 Anti-SARS-CoV-2 Monoclonal Antibody Injection in Chinese Healthy Subjects After Intravenous Infusion of Single Dose
Status:
UNKNOWN
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double-blind placebo-controlled phase I clinical study to evaluate the tolerability safety pharmacokinetic profile and immunogenicity of JS016 anti-SARS-CoV-2 monoclonal antibody injection in Chinese healthy subjects after intravenous infusion of single doseEligible patients will be injection JS016 anti-SARS-CoV-2 monoclonal antibody
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None