63
Participants
Start Date
December 9, 2017
Primary Completion Date
May 20, 2018
Study Completion Date
June 19, 2018
Esketamine DPI
Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.
Esketamine DPI
"Participants will receive different dosing sequences of Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A of the study.~Dose: very low, low, medium, high."
Esketamine DPI
"Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. There will be dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A and PART B of the study.~Dose: very low, low, medium, high."
Placebo DPI
"Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio.~In each cohort, number of placebo inhalations within a dosing sequence will correspond to number of Esketamine DPI inhalations."
BioResearch Group Sp. z o.o., Kajetany
Lead Sponsor
National Center for Research and Development, Poland
OTHER
Celon Pharma SA
INDUSTRY