Safety and Tolerability Clinical Trial
Official title:
A Phase 1a, Randomized, Double-blind Placebo-controlled Study to Evaluate Safety and Tolerability and to Characterize the Pharmacokinetic Profile of Single Ascending Doses of Fenretinide Oral Capsules in Healthy Adult Volunteers
The goal of this clinical trial is to learn about a single dose of fenretinide in healthy volunteers, in both a fasted and fed state. The main questions it aims to answer are: •How well is a single dose of fenretinide tolerated? AND •How is a single dose of fenretinide metabolized in healthy volunteers? Participants will be asked to: - Remain confined in a clinical research unit for 5 days after dosing. - Provide blood samples for intense PK sampling and safety labs. - Fast for 10 hours prior to administration of study drug (fasted cohorts). - Consume a high fat meal prior to administration of study drug (fed cohort). - Return to the clinic for a single follow-up visit for safety assessments. Researchers will compare active fenretinide to placebo to see if fenretinide is more or less tolerable than placebo.
This study is a randomized, double-blind, placebo-controlled single ascending dose study. There are 3 planned dose-level cohorts (Cohorts 1-3). Each dose-level cohort will consist of 8 subjects (6 active + 2 placebo), who will be treated under fasted conditions. The subjects in the highest tolerated dose-level cohort will also be administered ISLA101 under fed conditions, in a cross-over manner (Cohort 4). Proposed doses are 300, 600, and 900 mg/m2 (equivalent to 8.1, 16.2, and 24.3 mg/kg). Each subject will be allocated to 1 dose level only. The study will include a 5-day stay in the clinical research unit followed by a final safety follow-up visit at Day 8. ;
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