| Eligibility |
Inclusion Criteria
1. Participants must sign an Institutional Review Board (IRB)/Independent Ethics
Committee (IEC) approved ICF before any study-specific procedures are performed.
2. Healthy adult male and female Japanese participants between 18 and 45 years of age,
inclusive, at the time of screening.
3. Body mass index (BMI) between 16.0 and 25.0 kg/m2, inclusive, at screening and Day -1.
4. Normal or clinically acceptable physical examination, clinical laboratory test values,
vital signs, and electrocardiogram (ECG) (12-lead ECG reporting heart rate and RR, PR,
QRS, QT, and QTc intervals), as determined by the investigator, at screening. Physical
examination, vital signs, body weight and BMI, clinical laboratory tests, pregnancy
test, urinalysis, urine drug screen, and alcohol screen will be repeated on Day -1
(see Table 2-1) and must also be normal or clinically acceptable, as deemed by the
investigator.
5. Participants must be current on immunizations per local standards.
6. Participants must be first- or second-generation Japanese:
- First-generation Japanese are participants who may be living outside of Japan but
were born in Japan to parents of Japanese descent
- Second-generation Japanese are participants who were born outside of Japan to
first-generation Japanese parents
Exclusion Criteria
1. Women of childbearing potential who are unwilling to practice a highly effective
method of birth control for the duration of the study and for 5 months following
treatment with the investigational product or until the scheduled end-of-study (EOS)
(whichever is longer). Acceptable methods of effective birth control include:
- Abstinence
- Surgical methods: bilateral tubal ligation or vasectomy for the male sexual
partner
- Hormonal methods
- Intrauterine device (IUD)
- Two barrier methods (one by each partner)
- The male must use a condom (latex or other synthetic material)
- The female may select one of the following barrier methods: diaphragm,
cervical, or contraceptive sponge
2. Women who are lactating or breastfeeding.
3. Women with a positive pregnancy test.
4. Women planning to become pregnant during the study or within 5 months following
treatment with investigational product.
5. History or evidence of a clinically significant disorder (including psychiatric),
condition, or disease that, in the opinion of the investigator, would pose a risk to
participant safety or interfere with the study evaluation, procedures, or completion.
6. History or evidence of any bacterial, viral, parasitic, or systemic fungal infections
within the past 30 days prior to investigational product administration (eg, upper
respiratory tract infection, viral syndrome, flu-like symptoms). Exception: a simple,
short-duration common cold within the past 14 days prior to investigational product
administration.
7. A recent infection (within 6 months of randomization) requiring inpatient
hospitalization or intravenous antibiotics.
8. Known positive tuberculin skin test or exposure to an individual with tuberculosis
(TB) or positive QuantiFERON® test or local equivalent (eg, T-Spot®) consistent with
previous exposure to TB prior to or during screening (if not treated with appropriate
chemoprophylaxis).
9. Tuberculosis or fungal infection seen on available chest x-ray taken within 6 months
of screening or at screening.
10. History of malignancy of any type, other than surgically excised nonmelanomatous skin
cancers, within 5 years prior to randomization.
11. Positive test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface
antigen (HBsAg), or hepatitis C virus (HCV) at screening.
12. Positive screen for alcohol and/or potential drugs of abuse at screening or prior to
randomization.
13. Receiving or has received any investigational drug (or is currently using an
investigational device) within 30 days or 5 half-lives (whichever is longer), prior to
receiving investigational product.
14. Use of any over-the-counter (OTC) or prescription medications within the 14 days or 5
half-lives (whichever is longer), prior to receiving investigational product.
Acetaminophen (up to 2 g per day and not more than 4 g per week) for analgesia will be
allowed. Hormonal contraceptives are allowed.
15. All herbal medicines (eg, St. John's wort) and supplements consumed by the participant
within the 30 days prior to receiving investigational product, and continuing use if
applicable, will be reviewed by the investigator and the ICON medical monitor. Written
documentation of this review and Amgen acknowledgment of the decision made with
respect to eligibility is required for participant participation.
16. Donated blood (including blood products) or experienced loss of blood = 500 mL within
2 months of screening.
17. Received live vaccines = 3 months prior to investigational product administration or
are scheduled to receive a live vaccine within 3 months following treatment with
investigational product.
18. Known or suspected sensitivity to products derived from mammalian cell lines.
19. Known allergy to natural rubber (latex).
20. Previously received adalimumab or a biosimilar of adalimumab.
21. History of alcohol and/or substance abuse within the last 12 months from screening.
22. Participants who use > 10 cigarettes per day within the last 3 months or not able to
abide by the smoking policy of the clinical pharmacology unit (CPU).
23. Inability or unwillingness to reside at the CPU for 2 consecutive days or inability to
be available for follow-up assessments or protocol-required procedures.
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