Ignite Creation Date:
2024-05-05 @ 10:51 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01202695
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2010-09-13
Brief Title:
Safety and Pharmacokinetics Study of Human Monoclonal Antibody AVP-21D9
Sponsor:
Emergent BioSolutions
Organization:
Emergent BioSolutions
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:
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 09-0008 | OTHER_GRANT | HHSN272200800040C | None |