Eligibility Details:
Inclusion Criteria:
1. Nonsmoking, healthy (Caucasian and Japanese) participants.
Japanese participants must satisfy the following requirements:
1. Must have been born in Japan to Japanese parents and Japanese grandparents
2. Must have lived no more than 5 years outside of Japan
3. Must not have changed their life style or habits, including diet, while living outside
of Japan
Exclusion Criteria:
1. Clinically significant illness that requires medical treatment within 8 weeks or a
clinically significant infection that requires medical treatment within 4 weeks of
dosing
2. Females who are breastfeeding or pregnant at Screening or Baseline.
3. Females of childbearing potential who did not use a highly effective method of
contraception within 28 days before study entry, and do not agree to continue to use
contraception throughout the entire study period and for at least 28 days after study
drug discontinuation
4. Males that have female partners that are of childbearing potential that refuse to use
a highly effective method of contraception during the study, except for those who have
had a successful vasectomy.
5. Evidence of disease that may influence the outcome of the study within 4 weeks before
dosing; example, psychiatric disorders and disorders of the gastrointestinal tract,
liver, kidney, respiratory system, endocrine system, hematological system,
neurological system, or cardiovascular system, or participants who have a congenital
abnormality in metabolism
6. Any clinically abnormal symptom or organ impairment found by medical history, physical
examinations, vital signs, ECG finding, or laboratory test results that requires
medical treatment at Screening or Baseline
7. A prolonged QT (that is, corrected QT interval [QTc] Fridericia interval greater than
[>] 450 milliseconds) demonstrated on ECG at Screening or Baseline. A history of risk
factors for torsade de pointes (example, heart failure, hypokalemia, family history of
long QT Syndrome)
8. Persistent systolic blood pressure (SBP) >130 millimeters of mercury (mmHg) or
diastolic blood pressure (DBP) >85 mmHg at Screening or Baseline. One repeat
measurement will be allowed
9. Heart rate less than 45 or more than 100 beats/minute at Screening or Baseline
10. Known history of clinically significant drug allergy at Screening or Baseline
11. Known history of food allergies or presently experiencing significant seasonal or
perennial allergy at Screening or Baseline
12. Any history of hypersensitivity reaction to a foreign protein, with clinical features
of Grades 2 to 4 as described in National Cancer Institute-Common Terminology Criteria
for Adverse Events (CTCAE) Version 5.0, immunoglobulin A (IgA) deficiency, or
significant autoimmune disease or disorder. Participants with hypersensitivity
reactions to foreign protein with clinical features limited to nasal or conjunctival
symptoms such as in allergic rhinitis do not need to be excluded.
13. Known to be human immunodeficiency virus (HIV) positive at Screening
14. Active or chronic (including asymptomatic) viral hepatitis (A, B or C) as demonstrated
by positive serology at Screening. For hepatitis B serology, this refers to positive
for hepatitis B core antibody (HBcAb, Immunoglobulin M [IgM] type) or hepatitis B
surface or core antigens (HBsAg, HBcAg). For hepatitis C serology, a positive result
for screening serological testing must be confirmed by qualitative hepatitis C virus
ribonucleic acid (RNA)
15. History of drug or alcohol dependency or abuse within the 2 years before Screening, or
those who have a positive urine drug test or breath (or urine) alcohol test at
Screening or Baseline
16. Intake of over-the-counter medications within 2 weeks before dosing
17. Currently enrolled in another clinical study or used any investigational drug or
device within 30 days (or 5 half-lives, whichever is longer) preceding informed
consent
18. Exposure to any biologic drug within 90 days or at least 5 half-lives (whichever is
longer), or within 4 weeks for vaccines, before Screening
19. Engagement in strenuous exercise within 2 weeks before check-in (example, marathon
runners, weight lifters, etc.)
20. Any contraindication to continuous cerebrospinal fluid (CSF) sampling via indwelling
lumbar catheter or via lumbar puncture (LP)
21. Any history of or current blood clotting or bleeding disorder that is not under
adequate control, including a platelet count less than (<) 50,000, international
normalized ratio (INR) >1.3, or partial thromboplastin time (PTT) > upper limit of
normal (ULN) at Screening or Baseline. Participants receiving anticoagulation therapy
or identified at risk for hemorrhage
22. Any lifetime suicidal behavior or psychiatric disease. Whenever possible, medical
records should be reviewed to confirm absence of history of psychiatric disease or use
of medications to treat psychiatric disease.
23. Any current or prior history of suicidal behavior or psychiatric disease identified by
the psychiatrist at the Screening Visit
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
