Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01140126
Status:
COMPLETED
Last Update Posted:
2011-07-11
First Post:
2010-06-07
Brief Title:
Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults
Sponsor:
United Biomedical
Organization:
United Biomedical
Study Overview
Official Title:
A Phase I Open-label Single-dose Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults
Status:
COMPLETED
Status Verified Date:
2011-07
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 purpose of this Phase I study is to determine whether the antibody UB-421 targeting the HIV-1 receptor on the CD4 molecule domain 1 of T-lymphocytes and monocytes is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells thus UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection
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 |
|---|---|---|---|
| Protocol A101-HIV | OTHER | UBI-Asia | None |