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Study to Examine the Effects of Oral Fenretinide

NCT06528457 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-24

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Island Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Bert Slade, MD · CCRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-05
Primary Completion
2025-05-21
Completion
2025-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06528457 on ClinicalTrials.gov