To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17
Condition: Healthy
Intervention: CT-P17; CT-P17
Intervention description: subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks; subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was phase 1, randomized, open-label, two-arm, parallel group, single-dose study,
      which was designed to compare the pharmacokinetics (PK) and safety of CT-P17 SC
      administration via AI and PFS in healthy subjects. Approximately 180 subjects were enraollend
      and randomly assigned to one of the two treatment arms in a 1:1 ratio. In each treatment arm,
      all subjects received a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed
      by 10 weeks during which PK, safety, and immunogenicity measurements were made. The
      randomization to treatment assignment was stratified by body weight (≥80 kg vs. <80 kg) as
      measured on baseline (Day -1), gender (male vs. female) and study center.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects who meet all of the following criteria will be considered eligible to participate
        in the clinical study:

          1. Healthy male or female subjects, between the ages of 18 and 55 years, both inclusive
             (healthy is defined as no clinically relevant abnormalities identified by a detailed
             medical history, full physical examination, including blood pressure and heart rate
             measurement, 12-lead electrocardiogram [ECG], and clinical laboratory tests prior to
             the administration of the study drug).

          2. Subject with C-reactive protein ≤1.5 times the upper limit of normal (ULN).

          3. Subject has adequate liver function as determined by following results:

               -  Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5
                  times ULN and

               -  Total bilirubin ≤1.5 times ULN.

          4. Subject is informed and able to understand the full nature and purpose of the study,
             including possible risks and side effects, and is given ample time and opportunity to
             read and understand this information. The subject has the ability and agrees to
             cooperate with the investigator and must sign and date the written informed consent
             prior to performing any of the screening procedures.

          5. BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth.

          6. Subject and their partner of childbearing potential must agree to use highly effective
             method of contraception as specified in Section 5.8.2 throughout the study and for 5
             months after the administration of the study drug. A man or woman is of childbearing
             potential if, in the opinion of the investigator, he or she is biologically capable of
             having children and is sexually active. Male and female subjects and their partners
             who have been surgically sterilized for less than 24 weeks prior to the date of
             informed consent must agree to use any medically acceptable methods of contraception.
             Menopausal females must have experienced their last period more than 1 year prior to
             the date of informed consent to be classified as not of childbearing potential.

        Exclusion Criteria:

        Subjects who meet any of the following criteria will not be considered eligible to
        participate in the clinical study:

          1. Subject has a medical history and/or condition including one or more of the following
             disease(s):

               -  History and/or current presence of clinically significant atopy (e.g., allergic
                  asthma, eczematous dermatitis), known or suspected clinically relevant
                  hypersensitivity or allergic reactions to any of the excipients of study drug,
                  other murine and human proteins or immunoglobulin products.

               -  History of infection with hepatitis B (active or carrier of hepatitis B),
                  hepatitis C, human immunodeficiency virus (HIV) or syphilis. However, a subject
                  with history of hepatitis B virus is allowed if resolved. Subject will be
                  enrolled based on hepatitis B infection eligibility criteria, specified in
                  Section 6.2.3.

               -  History of invasive systemic fungal infections (including histoplasmosis,
                  coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
                  pneumocystosis, etc.) or other opportunistic infections judged by the
                  investigator, including local fungal infections or a history of herpes zoster.

               -  History of and/or current cardiac (including New York Heart Association class
                  III/IV heart failure), gastrointestinal, renal, endocrine, neurologic,
                  autoimmune, hepatic, hematological (including pancytopenia, aplastic anemia or
                  blood dyscrasia, etc.), metabolic (including diabetes mellitus), or pulmonary
                  disease classed as significant by the investigator.

               -  History of any malignancy.

               -  History of systemic or local infection, a known risk for developing sepsis,
                  and/or known active inflammatory process or evidence of an infection requiring
                  in-patient hospitalization or intravenous antibiotics within 24 weeks prior to
                  the administration of the study drug (Day 1).

          2. Subject is considered to have a significant abnormal cardiac function in
             investigator's discretion determined by the laboratory results.

          3. Subject underwent surgical intervention or an operation within 4 weeks prior to the
             administration of the study drug (Day 1) or plans to have a surgical procedure during
             the study period.

          4. Subject has active tuberculosis (TB), latent TB (defined as a positive result for
             interferon-γ release assay [IGRA] with no active lesion in examination of chest X-ray
             without any sign or symptom of TB), a history of TB, had close contact with a person
             with active TB or traveled to areas within a high incidence of TB within 8 weeks prior
             to the administration of the study drug (Day 1) or has plans to travel to the area in
             which TB is prevalent during the study period. If the result of IGRA is indeterminate
             at Screening, retest will be allowed only once during the Screening period. If the
             repeated IGRA result is again indeterminate or positive, the subject will be excluded
             from the study. If the repeated IGRA result is negative, the subject may be included
             in the study.

          5. Female subject is pregnant or lactating or planning to be pregnant or to breastfeed
             before, during, or within 5 months after the administration of the study drug (Day 1).

          6. Male subject is planning to father a child or donate sperm within 5 months after the
             administration of the study drug (Day 1).

          7. Subject has received tumor necrosis factor-α blockers, or subject who has had exposure
             of a biologic agent (including but not limited to monoclonal antibodies or fusion
             protein) within 6 months prior to the administration of the study drug (Day 1).

          8. Subject used prescription (excluding hormonal birth control), over-the-counter drugs,
             dietary supplements, or herbal remedies that could affect the outcome of the study
             within 2 weeks prior to the administration of the study drug (Day 1).

          9. Subject has undergone treatment with an investigational drug or participated in
             another clinical trial for healthy subject or bioequivalence test within 90 days or 5
             half-lives (whichever is longer) prior to the administration of the study drug (Day 1)
             or plan to do so during the study.

         10. Subject received a live or live-attenuated vaccine within 4 weeks prior to the
             administration of the study drug (Day 1) or plan to do so until the 6 months after Day
             1.

         11. Subject has donated or lost 450 mL or more of whole blood within 8 weeks, or donated
             blood components within 4 weeks prior to the administration of the study drug (Day 1).

         12. Subject shows reasonable evidence of drug abuse (positive result for drug urine test
             and/or the opinion of the investigator).

         13. Subject has a history or presence of regular consumption exceeding an average weekly
             intake of >21 units of alcohol in recent 12 weeks prior to the administration of the
             study drug (Day 1). One unit is equivalent to a half-pint (285 mL) of beer/lager, one
             measure (25 mL) of spirits, or one small glass (125 mL) of wine. Subject is unwilling
             to avoid use of alcohol or alcohol containing foods, medications, or beverages within
             24 hours prior to admission (Day -1), and each study visit until completion of the
             study.

         14. Subject has smoked 10 or more cigarettes per day in the recent 12 weeks prior to the
             administration of the study drug (Day 1) and/or is unable to refrain from smoking up
             to 24 hours after the administration of the study drug.

         15. In the opinion of the investigator, the subject is not eligible for the study
             participation for any reason (including clinical laboratory results) or shows evidence
             of a condition (e.g., psychological or emotional problem, any disorder or resultant
             therapy) that is likely to invalidate an informed consent or limit the ability of the
             subject to comply with the protocol requirements. Subject is unable to understand the
             protocol requirements, instructions, study-related restrictions, or the nature, scope,
             and possible consequences of the clinical study or is unable to give written informed
             consent or to comply fully with the protocol.

         16. Subject is vulnerable (e.g., employees of the study center or any other individuals
             involved with the conduct of the study, or immediate family members of such
             individuals, persons kept in prison, or other institutionalized persons by law
             enforcement).