Study to Examine the Effects of Oral Fenretinide

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 5, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

August 31, 2025

Conditions
Dengue
Interventions
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).

Trial Locations (1)

13057

SUNY Upstate Medical University, East Syracuse

Sponsors
All Listed Sponsors
lead

Island Pharmaceuticals

INDUSTRY

NCT06528457 - Study to Examine the Effects of Oral Fenretinide | Biotech Hunter | Biotech Hunter