Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2025-12-16 @ 5:41 PM
Study NCT ID:
NCT04666350
Status:
None
Last Update Posted:
2024-04-29 00:00:00
First Post:
2020-11-24 00:00:00
Brief Title:
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays
Sponsor:
PATH
Organization:
PATH
Study Overview
Official Title:
Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays in Adults With Varying Plasmodium Falciparum Gametocyte Densities
Status:
None
Status Verified Date:
2022-12
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 proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval. The results will determine the type of pivotal trial design for a follow-on Phase 2b trial whose objective is to bridge the standard membrane feeding assay (SMFA) to the direct skin feeding assay (DSFA) and direct membrane feeding assay (DMFA) using a monoclonal antibody intervention, TB31F monoclonal antibody (mAb), which interrupts transmission from human to mosquito. The results from this experimental medicine study will inform whether the preferred "Before-After" trial design in which each human volunteer serves as their own internal control can be utilized for a follow-on Phase 2b trial.
Detailed Description:
The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays DSFA at 24-hour interval The results will determine the type of pivotal trial design for a follow-on Phase 2b trial whose objective is to bridge the standard membrane feeding assay SMFA to the direct skin feeding assay DSFA and direct membrane feeding assay DMFA using a monoclonal antibody intervention TB31F monoclonal antibody mAb which interrupts transmission from human to mosquito The results from this experimental medicine study will inform whether the preferred Before-After trial design in which each human volunteer serves as their own internal control can be utilized for a follow-on Phase 2b trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None