Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04994912
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers
Sponsor:
Elixiron Immunotherapeutics (Hong Kong) Ltd.
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:
COMPLETED
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:
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.
Detailed Description:
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
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: