| Eligibility |
Inclusion Criteria:
Subjects meeting all of the following criteria are eligible to participate in this study:
1. Willingness and ability to understand the purpose and risks of the study and provide
signed and dated informed consent prior to any procedures and be available for all
study visits.
2. Male or female of non-child bearing potential, between 18-55 years of age, inclusive,
on the day of signing the Informed Consent Form (ICF).
3. Body mass index (BMI) between 18-30 kg/m2, inclusive with a weight of at least 50 kg
and no more than 100 kg.
4. Female subjects must have a negative blood pregnancy test at screening and a negative
urine pregnancy test at Day -1.
5. Female subjects who are postmenopausal or surgically sterile (having had a
hysterectomy, bilateral oophorectomy, or tubal ligation). Determination of serum
follicle-stimulating hormone (FSH) will be done with FSH levels > 35 mIU/mL being
confirmative for menopause. For hysterectomy and tubal ligation, documented
confirmation will be requested.
6. Non-vasectomized male subjects having a female partner of childbearing potential must
agree to the use of an effective method of contraception until 90 days after the last
administration of study drug.
7. Male subjects have to agree not to donate sperm until 90 days after the last
administration of study drug.
8. Judged by the investigator to be in good health based upon the results of a medical
history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and
laboratory findings.
9. Discontinuation of all medications (including over-the-counter and/or prescription
medication, dietary supplements, neutraceuticals, vitamins and/or herbal supplements
such as Ginkgo biloba or Saint John's wort), except occasional paracetamol use
(maximum dose of 2 g/day and maximum of 10 g/2 weeks), at least 2 weeks prior to the
first study drug administration. In addition, subjects must agree to the prohibitions
and restrictions for this study.
10. Non-smokers, and not using any nicotine-containing products. A non-smoker is defined
as an individual who has abstained from smoking for at least 1 year prior to the
screening.
11. Negative urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabis,
cocaine, opiates, methadone, and tricyclic antidepressants) at screening and Day -1.
12. Negative alcohol breath test at screening and Day-1. Note: A retest can be done in
case of an out of range clinical laboratory test value that will determine a subject's
eligibility. This retest should preferably be done at an unscheduled visit. The result
of the retest will be considered for subject eligibility. If the retest is outside
normal reference ranges, the subject may be included only if the investigator judges
the abnormalities to be not clinically significant.
Exclusion Criteria:
Subjects meeting any of the following criteria are excluded from participation in this
study:
1. Known hypersensitivity to study drug ingredients or a significant allergic reaction to
any drug as determined by the investigator, such as anaphylaxis requiring
hospitalization.
2. Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus
(HCV) or any history of hepatitis from any cause with the exception of hepatitis A.
3. History of or a current immunosuppressive condition (e.g., human immunodeficiency
virus [HIV] infection).
4. History of or evidence of active or latent or inadequately treated infection with
Mycobacterium tuberculosis (TB) diagnosed by a positive QuantiFERON® TB-Gold In Tube
test or a positive tuberculin skin test ("Mantoux") in case of a weak positive
QuantiFERON® TB-Gold In Tube test.
5. Subjects with known clinically relevant immunological disorders.
6. History of severe allergic or anaphylactic reactions.
7. Symptoms of clinically significant illness in the 3 months before the initial study
drug administration.
8. Presence or having sequelae of gastrointestinal, liver, kidney or other conditions
known to interfere with the absorption, distribution, metabolism, or excretion of
drugs.
9. History of malignancy within the past 5 years (except for basal cell carcinoma of the
skin that has been treated with no evidence of recurrence).
10. Clinically relevant abnormalities detected on ECG regarding either rhythm or
conduction (e.g., QTcF > 450 ms [male subjects] or >470 [female subjects], or a known
long QT syndrome). A first degree heart block or sinus arrhythmia will not be
considered as a significant abnormality.
11. Clinically relevant abnormalities detected on vital signs
12. Significant blood loss (including blood donation [> 500 mL]), or had a transfusion of
any blood product within 12 weeks prior to the initial study drug administration or
plan one within 4 weeks after the end of the study.
13. Treatment with any drug known to have a well-defined potential for toxicity to a major
organ in the last 3 months preceding the initial study drug administration.
14. The subject has a history of consuming more than 21 (14 for females) units of
alcoholic beverages per week or has a history of alcoholism or drug/chemical/substance
abuse within past 2 years prior to screening (Note: one unit = 330 mL of beer, 110 mL
of wine or 28 mL of spirits). Consumption of a large quantity of coffee, tea (> 6 cups
per day) or equivalent.
15. Administration of an injectable drug within 30 days prior to the initial study drug
administration.
16. Concurrent participation, or participation within 8 weeks prior to the initial study
drug administration in a drug/device or biologic investigational research study, or
participation within 15 weeks prior to initial study drug administration in an
investigational research study with biologic response modifier administration.
17. Administration of a vaccine within 60 days prior to initial study drug administration.
18. Administration of any systemic immunosuppressant agent within 6 months prior to
initial study drug administration.
19. Administration of any systemic steroid within 2 months prior to initial study drug
administration;
20. Use of a prohibited therapy within 14 days prior to initial study drug administration.
21. Investigator or any sub-investigator, research assistant, pharmacist, study
coordinator, or other staff or relative thereof who is directly involved in the
conduct of the study.
22. Any condition or circumstances that in the opinion of the investigator may make a
subject unlikely or unable to complete the study or comply with study procedures and
requirements.
23. Pregnant or lactating women or women of childbearing potential.
24. Unsuitable vein for infusion and/or blood sampling.
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