A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD)

Inclusion Criteria:

- 18 to 65 years of age, inclusive

- Body weight at least 50 kg

- Healthy male or female subjects (Healthy Cohorts)

- Body mass index (BMI) 18 to 30 kg/m^2, inclusive (Healthy Cohorts)

- Nonsmoker for at least 90 days prior to dosing (Healthy Cohorts)

- Primary diagnosis of MDD without psychotic features (MDD Cohort)

- BMI 18 to 35 kg/m^2, inclusive (MDD Cohort)

- Current partial response to ongoing SSRI or SNRI antidepressant treatment at an
adequate dose and for at least 4 weeks (MDD Cohort)

- Clinical Global Impression of Severity (CGI-S) score 3 or greater (MDD Cohort)

- Other regimens stable for at least 8 weeks prior to screening (MDD Cohort)

Exclusion Criteria:

- Pregnant or lactating women

- History of alcohol or substance abuse in the past 6 months

- Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)

- Clinically relevant electrocardiogram (ECG) abnormalities or a personal or family
history of congenital long QT syndrome

- Participation in an investigational study within 90 days of screening

- Blood donation over 500 mL within 3 months of screening

- Hypersensitivity to any study medication or excipients

- Psychotic symptoms or comorbid mood disorder

- Significant suicide risk

- Major illness within 1 month before screening, or febrile illness within 1 week
(Healthy Cohorts)

- Average alcohol consumption of more than 2 units per day (Healthy Cohorts)

- Multi-drug therapy for depression including antidepressants or adjunctive medications
(MDD Cohort)

- Prior use of basimglurant (MDD Cohort)

- Cigarette use of greater than 1 pack per day (MDD Cohort)