Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515385
Status:
COMPLETED
Last Update Posted:
2022-02-22
First Post:
2007-08-09
Brief Title:
A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults
Sponsor:
MacroGenics
Organization:
MacroGenics
Study Overview
Official Title:
A Phase 1 Randomized Double-Blind Dose-Escalation Cohort Study to Evaluate the Safety Tolerability and Pharmacokinetics of a Single Intravenous Infusion of MGAWN1 a Neutralizing Humanized Monoclonal Antibody IgG1k to West Nile Virus in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2022-02
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:
The primary purpose of this phase 1 double-blind cohort study is to evaluate the safety tolerability and pharmacokinetics of escalating doses of MGAWN1 administered as a single intravenous IV infusion to healthy adults Subjects will be enrolled sequentially into one of 5 dose-level cohorts with 8 subjects in each cohort Six subjects in each cohort will receive MGAWN1 a Neutralizing Humanized Monoclonal Antibody IgG1k to West Nile Virus and 2 will receive a saline control
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DMID 06-0090 | None | None | None |