SUNCIST: A Study of Calmangafodipir in Healthy Japanese and Caucasian Subjects

Inclusion Criteria:

- BMI within 18.0 to 30.0 kg/m2 and body weight not less than 50 kg

- Blood pressure between 90 and 140 mmHg systolic, and no higher than 90 mmHg diastolic

- Non-smoker or not smoking for at least 12 months

- Be first generation Japanese (For Group 1 only), defined as:

1. Born in Japan

2. Has 2 Japanese biological parents and 4 Japanese biological grandparents

3. Has lived outside of Japan for less than 5 years

4. Has made no significant changes in lifestyle, including diet, since leaving Japan

Exclusion Criteria:

- Clinically significant abnormal values for hematology, clinical chemistry, urinalysis,
physical exam, vital signs, or electrocardiogram at screening

- Has a history of human immunodeficiency virus (HIV) antibody positive, or tests
positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C
antibody (anti-HCV) positive, or other clinically active liver disease, or tests
positive for HBsAg or anti-HCV at Screening.

- Has a history of drug or alcohol abuse

- Has previously received calmangafodipir or mangafodipir

- Welders, mine workers, or other workers in occupations (current or past) where high
manganese exposure is likely