The study is placebo-controlled and double-blinded, and will include up to five cohorts receiving escalating doses. As many as 35 subjects will be included, with six active subjects and one placebo subject per dose cohort. Subjects passing screening are admitted to a research clinic, placed on a controlled diet and have baseline blood pressures and laboratory values monitored for 24 hours.
The next morning, subjects receive a single dose of PL-3994 or placebo with blood pressures and laboratory values monitored for 24 hours. Every other week, another cohort of subjects will receive a higher dose of PL-3994 until a pre-specified blood pressure decrease is observed.
Based on the results of this study and the previously completed Phase 1 trial in healthy, non-hypertensive volunteers, a Phase II trial in patients with episodes of hypertensive urgency is planned for later 2008. Palatin is also developing PL-3994 for the treatment of acute decompensated congestive heart failure and plans to initiate a separate Phase II study in these patients later 2008.