Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528457
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Study to Examine the Effects of Oral Fenretinide
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Randomized Double Blind Placebo-Controlled Study to Examine the Prophylactic and Treatment Effects of a Single Dose Level of Oral Fenretinide in a Dengue Virus Challenge Model
Status:
RECRUITING
Status Verified Date:
2024-09
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:
PROTECT
Brief Summary:
This randomized placebo controlled single center study examines the extent to which 600 mgm2day of orally administered ISLA101 fenretinide given prophylactically or therapeutically may reduce or eliminate signs and symptoms of dengue virus DENV infection over 29 days following subcutaneous challenge of healthy subjects with Dengue 1 Live Virus Human Challenge DENV-1-LVHC Humoral and cellular immune responses both innate and adaptive circulating virus and changes in clinical laboratory measures will also be examined
Detailed Description:
Pharmacology studies have identified the potential for fenretinide to inhibit the binding of the DENV nonstructural protein 5 NS5 to host nuclear importins IMPs IMP-α and IMP-β1 thereby impairing infection and replication This Phase 2 study is to evaluate the effectiveness of fenretinide in an encapsulated oral formulation ISLA101 against challenge with Dengue 1 Live Virus Human Challenge DENV-1-LVHC product both prophylactically and therapeutically Oral doses will be taken with a high fat meal to improve absorption as fenretinide is known to have poor gut permeability attributed to its accumulation in lipophilic cell membranes
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