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A Phase 1 Pharmacokinetics and Pharmacodynamics of Ketamine Transdermal Drug Delivery System in Subjects With Sub-Optimally Responsive Major Depressive Disorders
The purpose of this study is to measure the amount of ketamine in blood over time in subjects diagnosed with Major Depressive Disorder (MDD) and explore the anti-depressive effects of ketamine delivered by transdermal patch.
SHX-C301 is a Phase 1, first in human, single-blind, multi-center clinical study to evaluate the pharmacokinetics (PK), safety and antidepressant effects of SHX-001 transdermal patch low dose delivered based on prediction and high dose delivered based on the estimation from the low dose PK in subjects with MDD and sub-optimally controlled by standard of care.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Clinical Research Site
Gaithersburg, Maryland, United States
Clinical Research Site
Boston, Massachusetts, United States
Clinical Research Site
Dayton, Ohio, United States
Start Date
December 28, 2018
Primary Completion Date
June 6, 2019
Completion Date
June 6, 2019
Last Updated
April 25, 2019
14
ESTIMATED participants
SHX-001 Active low dose
DRUG
Placebo
DRUG
SHX-001 Active High dose
DRUG
Lead Sponsor
Shenox Pharmaceuticals, LLC
NCT07115329
NCT06793397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07025720