Ignite Creation Date:
2025-12-18 @ 8:28 AM
Ignite Modification Date:
2025-12-23 @ 9:19 PM
Study NCT ID:
NCT04994912
Status:
None
Last Update Posted:
2025-06-24 00:00:00
First Post:
2021-07-19 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers
Sponsor:
None
Organization:
Study Overview
Official Title:
Title of Study: A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers
Status:
None
Status Verified Date:
2025-06
Last Known Status:
None
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:
To assess the safety and tolerability of single ascending intravenous (IV) doses of EI-001 in healthy volunteers
To assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers
To assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers
Detailed Description:
None
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?: