Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-28 @ 6:14 AM
Study NCT ID:
NCT01202695
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2010-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
Sponsor:
Emergent BioSolutions
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Primary:
• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo
Secondary:
* To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
* To evaluate the immunogenicity of AVP-21D9
• To compare the safety profile of a single intravenous administration of AVP-21D9 as compared with Placebo
Secondary:
* To evaluate the pharmacokinetics (PK) of a single intravenous administration of AVP-21D9
* To evaluate the immunogenicity of AVP-21D9
Detailed Description:
This is a sequential, dose-escalating healthy volunteer study of the safety and pharmacokinetics of intravenously-infused AVP-21D9.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DMID 09-0008 | OTHER_GRANT | HHSN272200800040C | View |