Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523153
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
A Study of the Investigational Monoclonal Antibody VYD2311 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Placebo-Controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Immunogenicity of a SARS-CoV-2-directed Monoclonal Antibody in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study to investigate the safety tolerability and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants
Detailed Description:
This is a Phase I first-in-human randomized double blind placebo controlled single escalating dose study to evaluate the safety tolerability pharmacokinetics and immunogenicity of VYD2311 a monoclonal antibody targeting SARS-CoV-2 in healthy volunteers
The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD2311 after a single IV or IM administration in healthy participants The secondary objectives are to evaluate the PK of VYD2311 after IV or IM administration and the immunogenicity of VYD2311 after IV or IM administration in healthy participants
The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD2311 after a single IV or IM administration in healthy participants The secondary objectives are to evaluate the PK of VYD2311 after IV or IM administration and the immunogenicity of VYD2311 after IV or IM administration in healthy participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None