Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517693
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Safety and Pharmacokinetics Study of PGT121414LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-Label Phase I Study of the Safety and Pharmacokinetics of PGT121414LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and pharmacokinetics PK of the potent broadly neutralizing anti-HIV monoclonal antibodies mAb PGT121414LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1
Detailed Description:
This is an open-label phase I study of the potent broadly neutralizing anti-HIV monoclonal antibodies mAb PGT121414LS alone and in combination with VRC07-523LS administered soon after birth in infants exposed to HIV-1 The study is designed to assess the safety and pharmacokinetics PK profile of one and two subcutaneous SC doses of PGT121414LS alone or in combination with VRC07-523LS through Week 12 and Week 24 respectively
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