Ketamine for Major Depressive Disorder

SHX-C301 is a Phase 1, first-in-human, single-blind, multi-centre sequential study to evaluate the pharmacokinetics, safety and antidepressant effects of SHX-001 transdermal patch in subjects with MDD inadequately controlled by standard of care.

Each subject will receive placebo, low dose (20 mg) and high dose (40 mg) patches in the same order across three study periods; primary outcomes include PK measures and safety/tolerability and exploratory antidepressant effects.

Inclusion Criteria:
Present a current depressive episode of at least 8 weeks
Have a body mass index (BMI) of 18-35 kg/m2 (inclusive) at screening
Agree to use adequate methods of contraception during the study (and for X days after discharge)

Exclusion Criteria:
A history of alcohol consumption exceeding 14 drinks/week within the 5 years before study entry.
Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication except ongoing stable dose of antidepressant.
Treatment with any investigational drug, use of any known CYP3A4 enzyme-inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 7 days prior to the first dose of study medication
A history of drug abuse or dependence within 180 days of screening
A febrile illness within 5 days prior to the first dose of study medication.
A known hypersensitivity to ketamine
A history of use ketamine for Major Depressive Disorder and did not respond to ketamine
Recent use of ketamine in any formulation for any indication (within 4 weeks prior to screening)

Company

Product

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Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

SHX-001 low

Interventions

Placebo patch

Interventions

SHX-001 high

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators