CompletedPhase 2

Study to Examine the Effects of Oral Fenretinide

United States15 participantsStarted 2024-09-05

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. History of hysterectomy
✓. Post-menopausal:
✓. Partners with an intrauterine device (IUD) in place for at least 3 months
✓. Barrier method (condom or diaphragm) for at least 14 days prior to screening
✓. Partners using stable hormonal contraceptive for at least 3 months prior to the study
✓. History of vasectomy at least 3 months prior to signing the Informed Consent Form

What they're measuring

Characterization of DENV viremia following inoculation

Timeframe: over 29 days from inoculation

Trial details

NCT IDNCT06528457

SponsorIsland Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-21

View on ClinicalTrials.gov More Dengue trials