| Eligibility |
Inclusion Criteria
1. Healthy male, aged 18-55 years (inclusive).
2. A body weight between 65.0-90.0 kg (inclusive) and a body mass index between 20.0-29.9
kg/m2 (inclusive)
3. 12-lead electrocardiogram results without clinically significant abnormal.
4. Systolic blood pressure = 140 and = 90 mmHg, diastolic blood pressure = 90 and = 50
mmHg and pulse rate = 45 and = 90 beats per minute or assessed as not clinically
significant.
5. Physical examination results without clinically significant abnormal findings.
6. Clinical laboratory results within the normal range or outside the normal range but
assessed as not clinically significant.
7. Male subjects who did not have surgical sterilisation must be willing to abstain from
sexual intercourse or willing to use a condom in addition to having their female
partner use another form of contraception such as an intra-uterine device, oral
contraceptive, injectable progesterone, sub-dermal implant, or a tubal ligation unless
their partners are infertile from the time of the investigational product (IP)
administration until 5 months after the IP administration.
8. Willing and able to comply with study procedures including lifestyle consideration.
9. Able to provide written informed consent prior to any study procedures.
Exclusion Criteria
1. A history and/or current presence of clinically significant atopic, hypersensitivity
or allergic, also including known or suspected clinically relevant drug
hypersensitivity to adalimumab or to any of the excipients.
2. A history of and/or current clinically significant gastrointestinal, renal, hepatic,
haematological, pulmonary, neurologic, psychiatric, drug or alcohol abuse, or allergic
disease excluding mild asymptotic seasonal allergies.
3. Either active or latent tuberculosis (TB) or a history of TB.
4. A history of invasive systemic fungal infections or other opportunistic infections.
5. A history of any systemic or local infection, a known risk for developing sepsis
and/or known active inflammatory process within 180 days prior to Randomisation.
6. A sign of ongoing or chronic inflammation process defined as high blood concentration
of C reactive protein (> 1.5 times the upper limit of normal).
7. A history of serious infection (associated with hospitalisation and/or which required
intravenous antibiotics) within 180 days prior to Randomisation.
8. Previously been treated with adalimumab.
9. Previously been exposed to a monoclonal antibody or fusion protein (other than
adalimumab) within 180 days prior to Randomisation and/or there is a confirmed
evidence or clinical suspicion of immunogenicity from previous exposure to a
monoclonal antibody or fusion protein.
10. Previously been exposed to an immunosuppressive agent or biological agent (any other
than a monoclonal antibody or fusion protein) within 120 days prior to Randomisation.
11. Received live vaccine(s) within 30 days prior to Randomisation or who will require
live vaccine(s) during the study period.
12. A history of and/or current cardiac disease defined as one of the following:
1. Personal or family history of prolonged QT interval syndrome or Torsade de
Pointes.
2. QT interval corrected by Fridericia's formulas > 450 msec or PR interval outside
the range 120 to 220 msec.
3. Signs and symptoms or any history suggestive for heart failure.
4. Any other cardiac abnormalities or conditions assessed as clinically significant.
13. Impaired liver, pancreas and biliary system as determined by one of the following:
1. Serum alanine transaminase and/or aspartate transaminase = 1.5 times the upper
limit of normal.
2. Gallbladder or bile duct disease classified as clinically significant.
3. Acute or chronic pancreatitis.
4. A positive hepatitis C virus antibody test or hepatitis B virus surface antigen
test, or signs for active or chronic hepatitis B.
5. Hepatic disease classified as clinically significant.
14. A positive test result for human immunodeficiency virus, or have a history of
immunodeficiency.
15. A history of malignancy (including lymphoma and leukaemia) other than a successfully
treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or
localised carcinoma.
16. Had surgery within 90 days prior to Randomisation, and/or who plan to have an
operation during the study period.
17. A history and/or current presence of an illness within 14 days prior to Randomisation
that is classified as clinically significant.
18. Have a history of and/or current Coronavirus Disease-19 (COVID-19) defined as one of
the following:
1. Positive test result for COVID-19 confirmed by severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) using real-time reverse transcriptase polymerase chain
reaction (RT-PCR) at Day -1.
2. Signs and symptoms consistent with COVID-19 30 days prior to Randomisation.
3. Have had a positive test result for COVID-19 confirmed by SARS-CoV-2 detection
using real-time RT-PCR.
4. Had severe course of COVID-19.
19. Smoked more than 10 cigarettes, 2 cigars or 2 pipes per day within 90 days prior to
Screening.
20. Regular consumption of alcoholic beverages that exceeds 14 units.
21. A positive urinary drug screening result.
22. Any prescription medicine or over-the-counter medicines (except paracetamol) that
might have an effect on the objectives of the study in the opinion of the
Investigator, within 30 days prior to Randomisation.
23. Donated > 100 mL blood or plasma within 28 days prior to Randomisation.
24. Participated in another study with an investigational drug within 60 days prior to
Randomisation or are currently participating in or intending to participate in another
clinical study of an investigational drug before completion of all scheduled
evaluations in this clinical study.
25. Subjects who, in the opinion of the Investigator, are not likely to complete the study
for whatever reason.
26. Subject who is the Investigator or any sub-Investigator, research assistant,
pharmacist, study coordinator, other staff or relative thereof directly involved in
the conduct of the clinical study.
27. Vulnerable subjects.
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