30
Participants
Start Date
March 31, 2016
Primary Completion Date
December 15, 2020
Study Completion Date
December 15, 2020
SPM Emulsion, Dose-modality
"Phase 1a Dose-Finding oral SPM administration of increasing dose (15ml, 30ml, and 60ml) by the following schedule:~Days 1 to 5: 15 ml; Days 6 to 14: Washout, no SPM administration; Days 15 to 19: 30 ml; Days 20-28: Washout, no SPM administration; Days 29-33: 60 ml"
SPM Softgel, Dose-Modality
Phase 1b Dose-Finding oral softtel SPM administration of two different doses (2 softgel vs 4 softgel) Days 0 to 5: 2 SPM softgel; Days 6 to 21: Washout, no SPM administration; Days 22 to 26: 4 SPM softgel; Days 27-42: Washout, no SPM administration
Placebo Softgel
Days 43-47: 4 Placebo softgel; Day 48-64 Washout
University of California San Francisco, San Francisco
University of California, San Francisco
OTHER