15
Participants
Start Date
September 5, 2024
Primary Completion Date
June 30, 2025
Study Completion Date
August 31, 2025
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).
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.
Placebo
Placebo capsules will be administered orally as one dose of 300 mg/m2 each 12 hours (q12 +/-1 h).
SUNY Upstate Medical University, East Syracuse
Lead Sponsor
Island Pharmaceuticals
INDUSTRY