Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers

NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy
in animal models of affective disorders including major depressive disorder. The purpose of
this study is to evaluate the safety and tolerability of multiple oral (PO) ascending doses
of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in
serum chemistry, hematology, and urinalysis, changes in physical examination findings,
psychotomimetic findings and subject-reported symptoms.

Inclusion Criteria:

- Male and female subjects

- Aged 18 to 55 years

- For female subjects, surgically sterile or at least 2 years menopausal, or using an
acceptable method of birth control. If of childbearing potential, have a documented
negative blood or urine pregnancy test within 24 hours prior to dosing.

- Clinical laboratory values <2 times upper limit of normal (ULN) or deemed not
clinically significant by the investigator

- Ability to understand the requirements of the study, provide written informed
consent, abide by the study restrictions, and agree to return for the required
assessments

Exclusion Criteria:

- Human immunodeficiency virus (HIV) infection, or hepatitis or other ongoing
infectious disease.

- Current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1
unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of
the investigator that subject may be alcoholic.

- Current abuse of illicit substances, using the Diagnostic and Statistical Manual
(DSM) IV definition of drug abuse.

- Current smoker or use of other tobacco products.

- Currently pregnant, planning to become pregnant during the course of the study, or
nursing mother.

- Type I or Type II diabetes.

- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or
squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.

- Currently taking prescription or over-the-counter medications including herbal
therapies, within 14 days of enrollment into the study.

- History of allergy, sensitivity, or intolerance to NMDAR ligands including ketamine,
dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or
concomitant use of such agents.

- Received another investigational drug or device within 30 days of enrollment in this
study.

- Previously participated in this study.

- Psychiatric disease including major depression, bipolar disorder, anxiety, or
schizophrenia, or other medical condition that, in the opinion of the investigator,
would interfere with the evaluation of the study drug safety. 13) In the option of
the Investigator or the Sponsor's Study Monitor, has a history of severe renal or
hepatic impairment, severe active hepatic disease, or other clinically significant
medical condition that may preclude safe study participation.