Seelos Therapeutics announced the dosing of the first subjects in a Phase I Pharmacokinetic (PK) and Pharmacodynamic (PD) profile study, SLS-002-102.
SLS-002-102 is a two-part, randomized, double-blind, placebo-controlled, parallel and crossover study of intranasal and intravenous ketamine which plans to enroll 62 healthy volunteers.
- 48 subjects in Part A (parallel) will be randomized into four arms to receive either 30mg, 75mg, 90mg of SLS-002 or placebo over 13 days.
- 14 subjects in Part B (crossover) will be randomized into three arms; 60mg of IV ketamine followed by 60mg SLS-002, 60mg SLS-002 followed by 60mg of IV ketamine, or placebo over 25 days.
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"This study should help clarify SLS-002's safety and tolerability across multiple intranasal doses, as well help to identify and understand any pharmacokinetic or pharmacodynamic differences compared with IV ketamine. This information will assist us in confirming the dosing strategy for the planned proof of concept study in patients with MDD suffering from ASIB,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos Therapeutics.
Preliminary data from this study is expected in the first quarter of 2020.
Upon successful completion of the Phase I studies, Seelos plans to conduct a Proof of Concept (PoC) study of Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD).