NCT06528457

Study to Examine the Effects of Oral Fenretinide

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Island Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This randomized, placebo controlled single center study examines the extent to which 600 mg/m2/day 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.

Conditions

• Dengue

Interventions

Type	Name	Description
DRUG	ISLA101	ISLA101 is an oral gelatin capsule containing 100 mg of fenretinide (N-\[4-Hydroxyphenyl\]retinamide, mw 391.56) dissolved in corn oil and polysorbate 80. ISLA101 capsules will be administered orally as one dose of 300 mg/m2 each 12 hours (q12 +/-1 h).
DRUG	Dengue 1 Live Virus Human Challenge (DENV-1-LVHC)	The DENV-1-LVHC investigational challenge material consists of the dengue-1 virus strain 45AZ5 as a powder, lyophilized for reconstitution. The product is reconstituted with 0.7 mL of water for injection (WFI) and diluted to a concentration of 6.5 x 103 PFU/mL.
OTHER	Placebo	Placebo capsules will be administered orally as one dose of 300 mg/m2 each 12 hours (q12 +/-1 h).

Timeline

• Start date: 2024-09-05
• Primary completion: 2025-05-21
• Completion: 2025-07-21
• First posted: 2024-07-30
• Last updated: 2025-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study