Safety and Pharmacokinetic Study of Inhaled Esketamine in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

December 9, 2017

Primary Completion Date

May 20, 2018

Study Completion Date

June 19, 2018

Conditions
Healthy Volunteers
Interventions
DRUG

Esketamine DPI

Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.

DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (1)

Unknown

BioResearch Group Sp. z o.o., Kajetany

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Center for Research and Development, Poland

OTHER

lead

Celon Pharma SA

INDUSTRY