A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects
Phase: PHASE1
Conditions: Healthy
Sponsor: Celltrion

CLINICAL STUDY PROTOCOL 
 
A Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose 
Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira 
(US-licensed Humira and EU-approved Humira) in Healthy Subjects 
Protocol Number CT-P17 1.1 
Sponsor: 
 
 
 
 
 
  
Sponsor Contact: 
 
 
 
 
 
 
SAE Reporting and Data 
Center: 
 
 
 
 
 
Version and Date of Protocol:  
Protocol Version 2.1, 08 Jan 2019 
 
CONFIDENTIAL 
 
All financial and nonfinancial support for this study will be provided by CELLTRION, Inc. The 
concepts and information contained in this document or generated during the study are considered 
proprietary and may not be disclosed in whole or in part without the expressed, written consent of 
CELLTRION, Inc. The study will be conducted according to the protocol and in compliance with the 
International Council for Harmonisation harmonised tripartite guideline E6(R2): Good Clinical 
Practice with the declaration of Helsinki (WMA 2013). Throughout this document, symbols 
indicating proprietary names (®, ™) are not displayed. The appearance of product names without these 
symbols does not imply that these names are not protected. 

CELLTRION, Inc. 
CT-P17 
Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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Declaration of Investigator 
 
I have read and understood all sections of the protocol entitled “A Phase 1, Randomized, 
Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the 
Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved 
Humira) in Healthy Subjects” and the accompanying investigator’s brochure. 
I agree to supervise all aspects of the protocol and to conduct the clinical investigation in 
accordance with the Protocol Version 2.1, dated 08 Jan 2019, the International Council for 
Harmonisation harmonised tripartite guideline E6 (R2): Good Clinical Practice and all 
applicable government regulations. I will not make changes to the protocol before consulting 
with CELLTRION, Inc. or implement protocol changes without institutional review board 
approval except to eliminate an immediate risk to subjects. I agree to administer study drug 
only to subjects under my personal supervision or the supervision of a sub-investigator. 
I will not supply the investigational drug to any person not authorized to receive it. 
Confidentiality will be protected. Subject identity will not be disclosed to third parties or 
appear in any study reports or publications. 
I will not disclose information regarding this clinical investigation or publish results of the 
investigation without authorization from CELLTRION, Inc. 
 
 
 
Signature of Principal Investigator 
 
Date 
 
 
 
Printed Name of Principal Investigator 
 
 
 

CELLTRION, Inc. 
CT-P17 
Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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Table of Contents 
Protocol Approval ...................................................................................................................... 2 
Declaration of Investigator ........................................................................................................ 3 
Table of Contents ....................................................................................................................... 4 
List of Tables .............................................................................................................................. 7 
List of Figures ............................................................................................................................ 7 
Protocol Synopsis....................................................................................................................... 8 
List of Abbreviations................................................................................................................ 14 
1 
Introduction ..................................................................................................................... 17 
1.1 
Background ............................................................................................................ 17 
1.2 
CT-P17 Product Description .................................................................................. 17 
1.3 
Nonclinical Studies ................................................................................................ 18 
1.4 
Clinical Studies ...................................................................................................... 18 
1.5 
Rationale for Study ................................................................................................ 19 
1.6 
Risk–Benefit Assessment ....................................................................................... 20 
2 
Study Objectives .............................................................................................................. 21 
2.1 
Primary Objective .................................................................................................. 21 
2.2 
Secondary Objective .............................................................................................. 21 
3 
Investigational Plan ......................................................................................................... 22 
3.1 
Study Design .......................................................................................................... 22 
3.2 
Study Overview ..................................................................................................... 22 
3.2.1 
Screening Period (Day -28 to Day -2) ...................................................... 22 
3.2.2 
Admission (Day -1) .................................................................................. 23 
3.2.3 
Study Period (Day 1 to Day 71) ............................................................... 23 
3.2.4 
End-of-Study Visit (Day 71) ..................................................................... 24 
4 
Study Population Selection and Withdrawal Criteria ...................................................... 25 
4.1 
Inclusion Criteria ................................................................................................... 25 
4.2 
Exclusion Criteria .................................................................................................. 26 
4.3 
Subject Withdrawal/Discontinuation and Replacement ......................................... 28 
4.4 
Premature Termination of the Clinical Trial .......................................................... 29 
5 
Study Treatments ............................................................................................................. 30 
5.1 
Method of Assigning Subjects to Treatment Arms ................................................ 30 

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Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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5.2 
Treatment Administered ......................................................................................... 30 
5.3 
Identity of Investigational Products ....................................................................... 30 
5.4 
Management of Clinical Supplies .......................................................................... 31 
5.4.1 
Study Drug Packaging, Labeling, and Storage ......................................... 31 
5.4.2 
Study Drug Accountability, Dispensing and Destruction ......................... 32 
5.5 
Treatment Compliance ........................................................................................... 33 
5.6 
Blinding.................................................................................................................. 33 
5.6.1 
Breaking the Blind .................................................................................... 33 
5.7 
Prior, Concomitant, and Prohibited Medications ................................................... 34 
5.8 
Subject Restrictions During the Study ................................................................... 34 
5.8.1 
Food, Fluid, and Activity .......................................................................... 34 
5.8.2 
Contraception ............................................................................................ 35 
6 
Study Assessments and Procedures ................................................................................. 37 
6.1 
Pharmacokinetic Assessments ............................................................................... 37 
6.2 
Safety Assessments ................................................................................................ 38 
6.2.1 
Adverse Events ......................................................................................... 38 
6.2.1.1 
Definitions of Adverse Events ................................................ 38 
6.2.1.2 
Eliciting and Documenting Adverse Events ........................... 40 
6.2.1.3 
Reporting Adverse Events ...................................................... 40 
6.2.1.4 
Reporting Serious Adverse Events ......................................... 41 
6.2.1.5 
Assessment of Severity ........................................................... 43 
6.2.1.6 
Assessment of Causality ......................................................... 43 
6.2.2 
Other Safety Assessments ......................................................................... 44 
6.2.2.1 
Immunogenicity Assessment .................................................. 44 
6.2.2.2 
Injection Site Reaction ............................................................ 45 
6.2.2.3 
Hypersensitivity/Allergic Reactions Monitoring .................... 45 
6.2.2.4 
Vital Signs, Weight, and Height .............................................. 45 
6.2.2.5 
Electrocardiogram ................................................................... 45 
6.2.2.6 
Physical Examinations ............................................................ 46 
6.2.2.7 
Tuberculosis Assessments ....................................................... 46 
6.2.2.8 
Pregnancy ............................................................................... 47 
6.2.3 
Hepatitis B, Hepatitis C, Human Immunodeficiency Virus and 
Nontreponemal Test .................................................................................. 48 
6.2.4 
Clinical Laboratory Testing ...................................................................... 49 
6.2.5 
Local Site Pain .......................................................................................... 50 
6.3 
Sample Collections, Storage and Shipment ........................................................... 51 
6.3.1 
Sample Collections ................................................................................... 51 

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Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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6.3.1.1 
Pharmacokinetic Sampling ..................................................... 51 
6.3.1.2 
Interferon-γ Release Assay ..................................................... 51 
6.3.1.3 
Clinical Laboratory Testing .................................................... 51 
6.3.1.4 
Immunogenicity Sampling ...................................................... 51 
6.4 
Labeling, Storage, and Transportation of Samples ................................................ 52 
6.4.1 
Sample Labeling ....................................................................................... 52 
6.4.2 
Sample Storage and Shipment .................................................................. 52 
7 
Statistical Analysis Plan .................................................................................................. 53 
7.1 
Study Population .................................................................................................... 53 
7.1.1 
Disposition of Subjects ............................................................................. 53 
7.1.2 
Protocol Deviations .................................................................................. 53 
7.1.3 
Analysis Populations ................................................................................ 53 
7.2 
Pharmacokinetic Analyses ..................................................................................... 54 
7.2.1 
Primary Pharmacokinetic Analyses .......................................................... 54 
7.2.2 
Secondary Pharmacokinetic Analyses ...................................................... 54 
7.3 
Safety Analyses ...................................................................................................... 55 
7.3.1 
Demographic, Baseline, and Background Characteristics ........................ 55 
7.3.2 
Adverse Events ......................................................................................... 55 
7.3.3 
Immunogenicity Analysis ......................................................................... 56 
7.3.4 
Clinical Laboratory Test ........................................................................... 56 
7.3.5 
Electrocardiogram, Physical Examination, and Vital Signs ..................... 56 
7.3.6 
Tuberculosis Assessments ......................................................................... 56 
7.3.7 
Local Site Pain .......................................................................................... 56 
7.3.8 
Prior and Concomitant Medications ......................................................... 57 
7.4 
Sample Size Calculations ....................................................................................... 57 
7.5 
Interim Analyses .................................................................................................... 57 
7.6 
Data Quality Assurance.......................................................................................... 57 
8 
Investigator’s Obligations ............................................................................................... 59 
8.1 
Confidentiality ....................................................................................................... 59 
8.2 
Institutional Review Board .................................................................................... 59 
8.3 
Subject Information and Consent........................................................................... 60 
8.4 
Financial Disclosure and Obligations .................................................................... 60 
8.5 
Investigator Documentation ................................................................................... 60 
8.6 
Study Conduct ........................................................................................................ 61 
8.7 
Data Collection ...................................................................................................... 61 
8.7.1 
Electronic Case Report Forms and Source Documents ............................ 61 

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Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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8.8 
Adherence to Protocol............................................................................................ 62 
8.9 
Adverse Events and Study Report Requirements .................................................. 62 
8.10 Investigator’s Final Report .................................................................................... 62 
8.11 Records Retention .................................................................................................. 62 
8.12 Subject Identification Register ............................................................................... 63 
8.13 Publications ............................................................................................................ 63 
9 
Study Management .......................................................................................................... 64 
9.1 
Monitoring ............................................................................................................. 64 
9.1.1 
Data and Safety Monitoring Board ........................................................... 64 
9.1.2 
Monitoring of the Study............................................................................ 64 
9.1.3 
Inspection of Records ............................................................................... 64 
9.2 
Management of Protocol Amendments and Deviations......................................... 64 
9.2.1 
Modification of the Protocol ..................................................................... 64 
9.2.2 
Protocol Deviations .................................................................................. 65 
9.3 
Study Termination .................................................................................................. 65 
9.4 
Final Report ........................................................................................................... 65 
10 
Appendices ...................................................................................................................... 66 
10.1 Appendix: Schedule of Assessments ..................................................................... 66 
10.2 Appendix: VAS Subject’s Assessment of Pain ...................................................... 70 
11 
Reference List .................................................................................................................. 71 
 
List of Tables 
Table 5-1 
Identity of Study Drugs .................................................................................... 31 
Table 6-1 
Eligibility Based on Serology Markers for Hepatitis B Infection .................... 49 
Table 10-1 
Schedule of Assessments ................................................................................. 67 
List of Figures 
Figure 3−1 
Study Design Overview ................................................................................... 22 
 

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CT-P17 
Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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Protocol Synopsis 
Protocol Number: CT-P17 1.1 
Title: A Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the 
Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in 
Healthy Subjects 
Study Phase: Phase 1 
Study Center(s): 
 
Test Drug, Dose and Route of Administration:  
CT-P17, 40 mg/0.4 ml (100 mg/mL), a single subcutaneous (SC) injection via pre-filled syringe (PFS)  
Reference Drug, Doses and Routes of Administration: 
United States (US)-licensed Humira, 40 mg/0.4 ml (100 mg/mL), a single SC injection via PFS 
European Union (EU)-approved Humira, 40 mg/0.4 ml (100 mg/mL), a single SC injection via PFS 
Study Design and Rationale:  
CT-P17 is being developed as a proposed biosimilar of Humira (adalimumab). This study is a phase 1, 
randomized, multicenter, double-blind, three-arm, parallel group, single-dose, active comparator study, which 
is designed to demonstrate equivalence in pharmacokinetics (PK) of CT-P17 to US-licensed Humira and EU-
approved Humira in healthy subjects. Approximately 306 subjects will be enrolled and randomly assigned to 
one of the three treatment arms in a 1:1:1 ratio. In each treatment arm, all subjects will receive a single dose 
(40 mg) of either CT-P17, US-licensed Humira, or EU-approved Humira by SC injection via PFS on Day 1 
followed by 10 weeks during which PK, safety, and immunogenicity measurements will be made. The 
randomization to treatment assignment will be stratified by body weight (≥80 kg vs. <80 kg) as measured on 
baseline (Day -1), gender (male vs. female) and study center. 
 
A schematic of the study design is presented in Figure S1. 
Figure S1 
 
Study Design Overview 
 
 
Objectives:  
Primary objective 
• 
To demonstrate the PK similarity in terms of area under the concentration-time curve (AUC) from 
zero to infinity (AUC0-inf), AUC from zero to the last quantifiable concentration (AUC0-last), and 
maximum serum concentration (Cmax) of CT-P17, US-licensed Humira, and EU-approved Humira in 
healthy subjects (CT-P17 to US-licensed Humira, CT-P17 to EU-approved Humira, and US-licensed 
Humira to EU-approved Humira). 
 
Secondary objective 
• 
To evaluate the additional PK parameters, safety, and immunogenicity of CT-P17, US-licensed 
Humira, and EU-approved Humira in healthy subjects. 

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CT-P17 
Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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Number of Subjects: 
Approximately 306 subjects will be enrolled and randomly assigned (1:1:1) into one of three treatment arms 
as follows: 
• 
Treatment Arm 1 (n=102) CT-P17 
• 
Treatment Arm 2 (n=102) US-licensed Humira 
• 
Treatment Arm 3 (n=102) EU-approved Humira 
Study Population: Healthy male or female subjects 19 to 55 years of age, both inclusive, with a body mass 
index (BMI) between 18.0 and 29.9 kg/m2, both inclusive, are planned for enrollment. 
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 19 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 × ULN and  
• 
Total bilirubin ≤1.5 × 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 a highly effective method of 
contraception as specified in Section 5.8.2, throughout the study and for 5 months after the 
administration of assigned treatment. 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.  
• 
Known 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. 
• 
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. 

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CT-P17 
Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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• 
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, or had close contact with a person with active TB within 8 weeks prior to the 
administration of the study drug (Day 1). 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 a monoclonal antibody or fusion protein, or current use of a biologic (including but 
not limited to tumor necrosis factor [TNF] - α blockers).  
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 Screening visit. 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). 
Study Procedures: 

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Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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The study will include a Screening period, Admission, Study period, and End-of-Study (EOS) visit. All study 
procedures will be performed at the time points specified in the schedule of assessments (Table 10-1). 
 
Screening Period (Day -28 to Day -2): 
Subjects will sign and date the informed consent form and undergo procedures to determine eligibility. 
 
Admission (Day -1): 
Eligible subjects will undergo baseline assessments: recheck of inclusion and exclusion criteria, medical 
history, adverse events (AEs), prior and concomitant medications, clinical signs and symptoms of TB, 
clinical laboratory tests, vital signs, body weight, physical examination, check for history of drug abuse, 
nicotine and alcohol and urine pregnancy test in women of childbearing potential. 
Subjects will be admitted to the study center, and will be randomized to receive either CT-P17, US-licensed 
Humira, or EU-approved Humira once all pertaining tests have been concluded to confirm the eligibility 
during Screening period and Day -1 (if it is concluded that the subject is not eligible in Day-1 assessments, 
the subject will be considered as screening failure even if they passed the screening.)  
 
Study Period (Day 1 to Day 71): 
The study drug will be administered on the subject’s lower abdomen except for the 5 cm around the subject’s 
navel.  
Subjects will be confined to the study center until completion of the 48-hour assessments after the 
administration of the study drug (Day 1) and admission can be extended depending on the subject’s and study 
center’s availability, up to Day 7. The consecutive study visits will be carried out on an out-patient basis.  
 
Clinical laboratory testing and vital sign measurements will be obtained during the study period. For 
hypersensitivity monitoring, vital signs will be measured and either 3-lead or 12-lead ECG can be used. 
Local site pain using 100 mm visual analogue scale (VAS) and injection site reactions will be assessed 
after study drug administration. A physical examination will be performed. Immunogenicity samples will 
be obtained and AEs, concomitant medications, and clinical signs and symptoms of TB will be monitored 
throughout the study. Blood samples for PK analysis will be collected from all subjects at the predefined 
time points in the following table: 
PK sampling time points 
Day 1 Pre-dose (within 60 minutes prior to administration of the study drug) 
Day 1 (6 hours after the administration of the study drug); ±15 minutes 
Day 1 (12 hours after the administration of the study drug); ±1 hour 
Day 2 (24 hours after the administration of the study drug); ±2 hours 
Days 3, 4, 5, 5.5, 6, 6.5, 7, 8, and 9 (48, 72, 96, 108, 120, 132, 144, 168, and 192 hours, respectively, 
after the administration of the study drug); ±2 hours 
Days 15 and 22 (336 and 504 hours, respectively, after the administration of the study drug); ±4 hours  
Days 29, 43, 57, and 71 (i.e., EOS) after the administration of the study drug; ±1 day 
 
End-of-Study Visit (Day 71): 
The EOS visit will be performed on Day 71. Subjects will return to the study center and undergo the 
following PK and safety assessments: PK and immunogenicity sampling for CT-P17, US-licensed Humira, 
and EU-approved Humira; collection of information related to AEs and concomitant medications; serum 
pregnancy tests in women of childbearing potential; TB monitoring and IGRA; vital signs; body weight; 12-
lead ECG; clinical laboratory tests; and physical examination. The acceptable tolerance window for PK, 
safety, and immunogenicity assessments is ±1 day for EOS (Day 71) assessments. 

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Protocol Number CT-P17 1.1 
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Pharmacokinetic Assessments 
Primary endpoints:  
• 
Area under the concentration-time curve from zero to infinity (AUC0-inf) 
• 
Area under the concentration-time curve from zero to the last quantifiable concentration (AUC0-last) 
• 
Maximum serum concentration (Cmax) 
 
Secondary endpoints: 
• 
Area under the concentration-time curve extrapolated from time zero to infinity as a percentage of 
total AUC (%AUCextrap) 
• 
Time to Cmax (Tmax) 
• 
Apparent volume of distribution during the terminal phase after non-intravenous administration 
(Vz/F) 
• 
Terminal elimination rate constant (λz) 
• 
Terminal elimination half-life (t1/2) 
• 
Apparent total body clearance (CL/F) 
Safety and Immunogenicity Assessments 
Adverse events, serious AEs, AEs of special interest (injection site reactions, hypersensitivity/allergic 
reactions, infections, and malignancies), immunogenicity, hypersensitivity/allergic reaction assessments by 
additional ECG and vital sign monitoring (including systolic and diastolic blood pressure, heart rate, 
respiratory rate, and body temperature), vital sign and weight measurement, ECG, physical examination, 
IGRA, chest X-ray, pregnancy testing, clinical laboratory testing (including hematology, chemistry, and 
urinalysis), local site pain using 100 mm VAS, signs and symptoms of TB, and prior and concomitant 
medications monitored throughout the study. Hepatitis B, hepatitis C, HIV (HIV-1 and HIV-2) status and 
syphilis will be tested for the subject’s eligibility determination. 
Sample Size: 
A sample size of 91 subjects from each arm will provide at least 90% power to show similarity in PK of the 
followings; CT-P17 vs. US-licensed Humira, CT-P17 vs. EU-approved Humira and US-licensed Humira vs. 
EU-approved Humira using 90% confidence interval (CI) approach based on 80% to 125% equivalence 
margin, expected geometric mean ratio of 1.0, and coefficient of variation (CV) of 48%, which is assumed 
based upon historical PK data in healthy subjects. 
The sample size is calculated from a two one-sided alpha level of 0.05. Approximately 306 enrolled subjects 
(102 in each arm) are expected to yield at least 273 evaluable subjects (91 in each arm) with a 10% drop-out 
rate. By assuming that the primary PK parameters are highly correlated, the Type I/II error adjustment for 
multiplicity correction for PK parameters is not considered. 

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Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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Statistical Analyses: 
Pharmacokinetic analysis: The statistical analysis of the log-transformed primary endpoints (AUC0-inf, AUC0-
last, and Cmax) will be based on an analysis of covariance model with covariate(s). The similarity of PK 
between; CT-P17 vs. US-licensed Humira, CT-P17 vs. EU-approved Humira, and US-licensed Humira vs. 
EU-approved Humira will be concluded if the 90% CIs for ratios of geometric means of each comparison are 
entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax. The PK endpoints will be calculated 
using non-compartmental methods. The PK analysis will be conducted based on the PK population. 
Pharmacokinetic parameters will be presented in data listings and summarized in tables. The tables will 
display the following descriptive statistics: number of subjects, mean, standard deviation, median, minimum, 
maximum, geometric mean, and CV. 
For secondary endpoints, following PK parameters will be assessed: %AUCextrap, Tmax, Vz/F, λz, t1/2, and 
CL/F. 
Additional PK analyses may be performed as detailed in the statistical analysis plan. 
Safety and immunogenicity analysis: All safety and immunogenicity analyses will be conducted based on the 
safety population, and listed and summarized by treatment arm. The number and percentage of subject 
experienced AEs will be summarized by treatment arm using system organ class and preferred term. Adverse 
events will be summarized by severity and relationship to study drug. Serious adverse events will be listed 
separately. Adverse events will be recorded according to the Common Terminology Criteria for Adverse 
Events v5.0 and will be coded to system organ class and preferred term according to the Medical Dictionary 
for Regulatory Activities. Prior and concomitant medications will be coded using the WHO Drug Dictionary. 
These medications will be tabulated by drug class and preferred term.  
 

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Protocol Number CT-P17 1.1 
Protocol Version 2.1 
 
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List of Abbreviations  
Abbreviation 
Term 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine aminotransferase 
AS 
axial spondylitis 
AST 
aspartate aminotransferase 
AUC 
area under the concentration-time curve 
AUC0-inf 
area under the concentration-time curve from zero to infinity 
AUC0-last 
area under the concentration-time curve from zero to the last 
quantifiable concentration 
%AUCextrap 
Area under the concentration-time curve extrapolated from zero to 
infinity as a percentage of total AUC 
BMI 
body mass index 
CI 
confidence interval 
CL/F 
apparent total body clearance 
Cmax 
maximumserum concentration 
CSR 
clinical study report 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
coefficient of variation 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EMA 
European Medicines Agency 
EPAR 
European Public Assessment Report 
EOS 
end-of-study 
EU 
European Union 
FDA 
Food and Drug Administration  
HBcAb 
hepatitis B core antibody 
HBsAg 
HBsAb 
hepatitis B surface antigen 
hepatitis B surface antibody 
HCAb 
hepatitis C antibody 
HIV 
human immunodeficiency virus 
IB 
investigator’s brochure 
ICF 
informed consent form 

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Abbreviation 
Term 
ICH 
International Council for Harmonisation 
IgG1 
immunoglobulin G1 
IGRA 
interferon-γ release assay 
IRB 
institutional review board 
ITT 
intent-to-treat 
IV 
intravenous 
IVRS 
interactive voice response system 
IWRS 
interactive web response system 
λz 
terminal elimination rate constant 
MedDRA 
Medical Dictionary for Regulatory Activities 
OTC 
over-the-counter 
PFS 
pre-filled syringe 
PK 
pharmacokinetic(s) 
PT 
preferred term 
PVG 
pharmacovigilance 
RA 
rheumatoid arthritis 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SC 
subcutaneous 
SD 
SmPC 
standard deviation 
Summary of Product Characteristics 
SOC 
system organ class 
SOP 
standard operating procedure 
SUSAR 
suspected unexpected serious adverse reaction 
t1/2 
terminal elimination half-life 
TB 
tuberculosis 
TEAE 
treatment-emergent adverse event 
Tmax 
time to Cmax  
TNF 
tumor necrosis factor 
ULN 
upper limit of normal 
US 
USPI 
United States 
United States Prescribing Information 

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Abbreviation 
Term 
VAS 
visual analogue scale 
Vz/F 
apparent volume of distribution during the terminal phase after 
non-intravenous administration 
 

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1 Introduction 
1.1 Background 
Tumor necrosis factor (TNF)-α, a proinflammatory cytokine, is a key mediator of 
inflammation shown to be a central factor in inflammatory immune response 
(Harriman et al 1999; Hsia et al 2006). In general, TNF-α is produced mainly by 
macrophages, but also by a broad variety of other cell types. It has a wide spectrum of 
activities including coordinating host immune and inflammatory response to infectious, 
malignant, and autoimmune conditions. There are 2 types of TNF receptors, p55 and p75, 
part of a large family of structurally related cell-surface receptors (Bazzoni and Beutler 
1996). There is evidence that the p75 receptor stimulates T cells proliferation and suppresses 
TNF-α-mediated inflammatory responses, whereas the p55 receptor appears to be critical in 
triggering host defense and inflammatory responses (Tartaglia et al 1993; Peschon et al 
1998). 
Large amounts of TNF-α are released in response to lipopolysaccharide, other bacterial 
products, and interleukin-1. Tumor necrosis factor-alpha induces proinflammatory cytokines 
such as interleukin-1 and interleukin-6, enhances leukocyte migration, activates neutrophil 
and eosinophil functional activity, and induces acute phase reactants, other liver proteins, and 
tissue-degrading enzymes. Although there is a benefit to TNF-α expression in response to 
infection or injury, there are increased concentrations associated with a variety of 
inflammatory conditions such as rheumatoid arthritis (RA), Crohn’s disease, ulcerative 
colitis, uveitis, ankylosing spondylitis (AS), psoriatic arthritis, and psoriasis. 
Greater understanding of the role of inflammatory mediators has produced effective biologic 
treatments for inflammatory conditions, including Humira (adalimumab), a fully humanized 
anti-TNF-α monoclonal antibody. Adalimumab is structurally and functionally analogous to 
naturally occurring human immunoglobulin G1 (IgG1) and demonstrates a high specificity 
and affinity for TNF. Adalimumab binds to TNF-α and blocks its interaction with the cell 
surface TNF receptors, p55 and p75 (Humira SmPC 2018). It does not bind other cytokines 
such as lymphotoxin. Adalimumab also lyses surface TNF expressing cells in vitro in the 
presence of complement (Humira USPI 2018). 
1.2 CT-P17 Product Description 
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized 
monoclonal antibody that is being developed as a similar biological medicinal product to the 
reference product, Humira. The reference product was originally approved in the United 
States (US) in December of 2002 and in the European Union (EU) in September of 2003 

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(FDA 2002, EMA EPAR for Humira 2017, Humira SmPC 2018). In the EU, Humira is 
indicated for the following conditions: RA, juvenile idiopathic arthritis, axial 
spondyloarthritis (AS, axial spondyloarthritis without radiographic evidence of AS), psoriatic 
arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, 
pediatric Crohn’s disease, ulcerative colitis, uveitis and pediatric uveitis; in the US, Humira is 
indicated for the same conditions except axial spondyloarthritis without radiographic 
evidence of AS, pediatric plaque psoriasis, and pediatric uveitis (Humira USPI 2018, Humira 
SmPC 2018). 
The reference product, Humira, is supplied as a sterile, preservative-free solution of 
adalimumab for subcutaneous (SC) administration (Humira SmPC 2018). Humira is supplied 
in two strengths: 50 mg/mL (40 mg/0.8 mL) and 100 mg/mL (40 mg/0.4 mL). 
CT-P17 is manufactured using a Chinese Hamster Ovary cell line by fed-batch cell culture, 
followed by harvest, purification, formulation, and subsequent fill-finish operations. The 
primary amino acid sequences of adalimumab in CT-P17 are identical to those of Humira. 
CT-P17 will be supplied in a pre-filled syringe (PFS) at a concentration of 100 mg/mL (40 
mg/0.4 mL) as a clear to opalescent, colorless to brown liquid for subcutaneous 
administration. The CT-P17 drug product will have the same pharmaceutical form and 
strength as Humira and is intended to have a highly similar quality profile to Humira. 
CELLTRION, Inc. plans to seek approval for all indications for which the reference product 
has been approved by demonstrating similarity of CT-P17 with the reference product through 
an extensive array of quality, nonclinical and clinical comparability assessments. 
1.3 Nonclinical Studies 
Detailed information regarding the nonclinical pharmacology and toxicology of CT-P17 can 
be found in the investigator’s brochure (IB). 
1.4 Clinical Studies 
No clinical studies of CT-P17 have been performed. The safety, tolerability, and 
pharmacokinetics (PK) of Humira (adalimumab) in healthy subjects were evaluated in a 
series of phase 1 studies. 
Study DE024 was a single center, double-blind, randomized, placebo-controlled, parallel-
group, ascending single-dose study in healthy male subjects. A total of 80 subjects (60 active 
and 20 placebo) participated in the study. Active subjects received a single intravenous (IV) 
dose of 1 mg/kg Humira over 2 to 3 minutes or 0.1, 0.3, and 1 mg/kg Humira via SC 
injection. Results demonstrated that following SC administration of Humira the mean 

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maximum observed serum concentration (Cmax) and area under the concentration-time curve 
(AUC) from zero to infinity (AUC0-inf) increased with increasing dose, with dose proportional 
increases noted at the 0.3 and 1 mg/kg SC doses only. The time to Cmax (Tmax) ranged from 48 
to 336 hours and the mean half-lives ranged from 284 to 433 hours across doses. 
Study DE015 was an open-label, randomized, parallel-group, single-dose study to assess the 
absolute and relative bioavailability of three injectable formulations of human anti-TNF 
antibody D2E7 in healthy male and female subjects. Subjects received 40 mg D2E7 as three 
different formulations via IV (50 mg/mL D2E7, with Tween-80) or SC injection (25 mg/mL 
D2E7, without Tween-80; 50 mg/mL D2E7, with Tween-80; and 50 mg/mL D2E7, without 
Tween-80). The results indicated that the mean Cmax and Tmax for the three SC formulations of 
D2E7 were comparable. The overview and results of Studies DE024 and DE015 can be found 
in Clinical Pharmacology and Biopharmaceutics Review(s), FDA. 
Study M10-867 was a phase 1, single-dose, parallel-arm, single-blind, randomized study in 
healthy adult subjects. A total of 300 subjects were administered two formulations of Humira 
(40 mg/0.8 mL [50 mg/mL], reference vs. 40 mg/0.4 mL [100 mg/mL], test). The 90% CIs 
for the ratio of Cmax central values (101.9 – 115.2) and the ratio of AUC from time zero to 
1344 hours (AUC0-1344) central values (107.2 – 124.9) demonstrated comparable 
bioavailability of the two formulations. The overview and results of Study M10-867 can be 
found in the Product Monograph of Humira (HUMIRA Product Monograph 2018). 
An overview of the safety profile of Humira, including undesirable effects, can be found in 
the Humira Summary of Product Characteristics (SmPC), European Public Assessment 
Report (EPAR) for Humira, and United States Prescribing Information (USPI) for US-
licensed Humira (Humira SmPC 2018; EMA EPAR for Humira 2017; Humira USPI 2018).  
1.5 Rationale for Study 
The introduction of biosimilar (follow-on) medicinal products is desirable as they will 
enhance patient access by expanding the field of competing biotechnological treatments. The 
purpose of this study is to compare the PK, safety, and immunogenicity of the biosimilar test 
product (CT-P17) and the reference products (US-licensed Humira and EU-approved 
Humira) after a single SC injection of 40 mg of each product to healthy subjects following 
the recommendations of the guidance for industry, “Scientific Considerations in 
Demonstrating Biosimilarity with a Reference Product” (DHHS 2015).  
The dose of Humira (40 mg) selected for this study is in line with the approved labeling for 
Humira (Humira SmPC 2018; Humira USPI 2018).  

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The study will be conducted in healthy subjects to avoid potentially high variability of the 
exposure of adalimumab if administered to patients with underlying and/or concomitant 
disease and concomitant medications. Due to the long half-life of adalimumab 
(approximately 2 weeks), a parallel-group design will be used in this study. 
1.6 Risk–Benefit Assessment 
Information about the risk following the administration of adalimumab was taken from the 
prescribing information for US-licensed Humira (Humira USPI 2018) and Humira SmPC for 
EU-approved Humira (Humira SmPC 2018). In view of the structural, biological, and 
toxicological similarity to Humira, CT-P17 is expected to display a similar safety profile. 
The proposed safety screening and monitoring assessments are deemed to be sufficient to 
monitor potential risks of CT-P17 administration. Since adalimumab will be administered 
only once at the approved dosage of 40 mg, the overall risk of the study for healthy subjects 
is considered to be acceptable. No therapeutic benefit from adalimumab treatment is intended 
for the healthy subjects in this study. 

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2 Study Objectives 
2.1 Primary Objective 
• To demonstrate the PK similarity in terms of AUC0-inf, AUC0-last, and Cmax of CT-P17, 
US-licensed Humira, and EU-approved Humira in healthy subjects (CT-P17 to US-
licensed Humira, CT-P17 to EU-approved Humira, and US-licensed Humira to EU-
approved Humira) 
2.2 Secondary Objective 
• To evaluate the additional PK parameters, safety, and immunogenicity of CT-P17, 
US-licensed Humira, and EU-approved Humira in healthy subjects 

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3 Investigational Plan 
3.1 Study Design 
CT-P17 is being developed as a proposed biosimilar of Humira (adalimumab). This study is a 
phase 1, randomized, multicenter, double-blind, three-arm, parallel group, single-dose, active 
comparator study, which is designed to demonstrate equivalence in PK of CT-P17 to US-
licensed Humira and EU-approved Humira in healthy subjects. Approximately 306 subjects 
will be enrolled and randomly assigned to one of the three treatment arms in a 1:1:1 ratio. In 
each treatment arm, all subjects will receive a single dose (40 mg) of either CT-P17, 
US-licensed Humira, or EU-approved Humira by SC injection via PFS on Day 1 followed by 
10 weeks during which PK, safety, and immunogenicity measurements will be made. The 
randomization to treatment assignment will be stratified by body weight (≥80 kg vs. <80 kg) 
as measured on Day -1, gender (male vs. female) and study center. 
A schematic of the study design is presented in Figure 3−1. Refer to Section 3.2 for the study 
overview, including procedures to be performed during the study. 
Figure 3−1 
Study Design Overview 
 
3.2 Study Overview 
The study will include a Screening period, Admission, Study period, and End-of-Study (EOS) 
visit. All study procedures will be performed at the time points specified in the schedule of 
assessments (Table 10-1). 
3.2.1 Screening Period (Day -28 to Day -2) 
Subjects will sign and date the informed consent form and undergo procedures to determine 
eligibility. If necessary, a prescreening process may be carried out according to the standard 
operating procedures (SOP) of the study center.   

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During the screening period, retest for screening is permitted only once by the investigator’s 
judgement. If the repeated test result is again not suitable or indeterminate for inclusion, the 
subject will be screen failed.  
3.2.2 Admission (Day -1) 
Eligible subjects will undergo baseline assessments: recheck of inclusion and exclusion 
criteria, medical history, adverse events (AEs), prior and concomitant medications, clinical 
signs and symptoms of TB, clinical laboratory tests, vital signs, body weight, physical 
examination, check for drug abuse, nicotine and alcohol and urine pregnancy test in women 
of childbearing potential.  
Subject will be admitted to the study center, and will be randomized to receive either CT-P17, 
US-licensed Humira, or EU-approved Humira once all pertaining tests have been concluded 
to confirm the eligibility during Screening period and Day -1 (if it is concluded that the 
subject is not eligible in Day-1 assessments, the subject will be considered as screening 
failure even if they passed the screening).  
3.2.3 Study Period (Day 1 to Day 71) 
The study drug will be administered on the subject’s lower abdomen except for the 5 cm 
around the subject’s navel. 
Subjects will be confined to the study center until completion of the 48-hour assessments 
after the administration of the study drug (Day 1) and admission can be extended depending 
on the subject’s and study center’s availability, up to Day 7. The consecutive study visits will 
be carried out on an out-patient basis.  
Clinical laboratory testing and vital sign measurements, will be obtained during the study 
period. For hypersensitivity monitoring, vital sign measurements will be performed before 
the start of the study drug administration (within 15 minutes) and at 3, 6, 12, and 24 hours 
after the administration of the study drug on Day 1. The tolerance window for 
hypersensitivity monitoring is ±30 minutes for 3 and 6 hours, and ±60 minutes for 12 and 24 
hours after the administration. Either 3-lead or 12-lead electrocardiogram (ECG) can be 
used for hypersensitivity monitoring at 3 hours (±30 minutes) after the administration of the 
study drug on Day 1, and additional ECGs can be performed throughout the study if the 
subject experiences cardiac symptoms. Local site pain using 100 mm visual analogue scale 
(VAS) will be assessed immediately (within 15 minutes) after study drug administration (Day 
1) and injection site reactions will be assessed 30 minutes (±10 minutes) after study drug 
administration. A physical examination will be performed on Day 3. Immunogenicity 

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samples will be obtained in prior to the administration of the study drug on Day 1, and on 
Day 15, 29, 57 and 71. Adverse events, concomitant medications, and clinical signs and 
symptoms of TB will be monitored throughout the study. Blood samples for PK analysis 
will be collected from all subjects at the predefined time points in the following table: 
PK sampling time points 
Day 1 Pre-dose (within 60 minutes prior to administration of the study drug) 
Day 1 (6 hours after the administration of the study drug); ±15 minutes 
Day 1 (12 hours after the administration of the study drug); ±1 hour 
Day 2 (24 hours after the administration of the study drug); ±2 hours 
Day 3, 4, 5, 5.5, 6, 6.5, 7, 8, and 9 (48, 72, 96, 108, 120, 132, 144, 168, and 192 hours, respectively, after 
the administration of the study drug); ±2 hours 
Day 15 and 22 (336 and 504 hours, respectively, after the administration of the study drug); ±4 hours  
Day 29, 43, 57, and 71 (i.e., EOS) after the administration of the study drug; ±1 day 
3.2.4 End-of-Study Visit (Day 71) 
The EOS visit will be performed on Day 71. Subjects will return to the study center and 
undergo the following PK and safety assessments: PK and immunogenicity sampling for CT-
P17, US-licensed Humira, and EU-approved Humira; collection of information related to AEs 
and concomitant medications; serum pregnancy tests in women of childbearing potential; TB 
monitoring and interferon-γ release assay (IGRA); vital signs; body weight;12-lead ECG; 
clinical laboratory tests; and physical examination. The acceptable tolerance window for PK, 
safety, and immunogenicity assessments is ±1 day for EOS (Day 71) assessments. 

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4 Study Population Selection and Withdrawal Criteria 
Healthy male or female subjects 19 to 55 years of age, both inclusive, with a body mass index 
(BMI) between 18.0 and 29.9 kg/m2, both inclusive, will be enrolled. Approximately 
306 subjects (102 subjects in each arm) are planned to achieve at least 273 evaluable subjects 
(91 subjects in each arm). 
4.1 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 19 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 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 the following results: 
• 
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × 
ULN and,  
• 
Total bilirubin ≤1.5 × 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 a highly effective 
method of contraception as specified in Section 5.8.2, throughout the study and for 5 
months after the administration of assigned treatment. 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 

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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. 
4.2 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. 
• Known 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. 
• 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 IV antibiotics within 24 weeks prior to the administration of the 
study drug (Day 1). 

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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 TB, latent TB (defined as a positive result for IGRA with no active 
lesion in examination of chest X-ray without any sign or symptom of TB), a history of 
TB, or had close contact with a person with active TB within 8 weeks prior to the 
administration of the study drug (Day 1). 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 a monoclonal antibody or fusion protein, or current use of a biologic 
(including but not limited to TNF- α blockers). 
8. Subject used prescription (excluding hormonal birth control) or over-the-counter (OTC) 
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 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).  

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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 Screening visit. 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 the 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). 
4.3 Subject Withdrawal/Discontinuation and Replacement 
Subjects will be withdrawn from the study prematurely for the following reasons: 
• Withdrawal of consent: Subjects have the right to withdraw from the study at any time for 
any reason.  
• Protocol deviation of concern: The subject may be withdrawn by the investigator after 
discussion with the sponsor: 
– If protocol deviations that may affect study objectives occur, or 
– If it is discovered that the subject has entered the study in violation of the protocol. 
• Adverse event: If a subject reports symptoms that are considered unacceptable by the 
investigator and/or sponsor, he or she will be withdrawn from the study. 

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• Subject dies. 
When a subject withdraws from the study, the reason(s) for withdrawal shall be recorded by 
the investigator in both the source documents and electronic case report form (eCRF).  
If a subject withdraws prematurely after dosing, the subject will be asked to return to the 
study center and will undergo all EOS (i.e., Day 71) assessments. All subjects who withdraw 
from the study because of an AE or clinical laboratory abnormality will be followed-up at 
suitable intervals in order to evaluate the course of the AE or laboratory abnormality and to 
ensure resolution or stabilization of the event. The subsequent outcomes of these events will 
be recorded in the both the source documents and eCRF. 
For subjects who are lost to follow-up (i.e., those subjects whose status is unclear because 
they fail to appear for study visits without stating an intention to withdraw), the investigator 
will show due diligence by documenting in the source documents steps taken to contact the 
subject, e.g., dates of telephone calls, registered letters, etc. Subjects who fail to return for 
final assessments will be contacted by the center in an attempt to have him or her comply 
with the protocol. The status of subjects who fail to complete final assessments will be 
documented in the both the source documents and eCRF. 
For screen failed subjects, rescreen will be allowed only once after receiving informed 
consent form (ICF) again with new screening ID; however, subjects withdrawn (after 
randomization) will not be replaced. 
4.4 Premature Termination of the Clinical Trial 
The sponsor reserves the right to terminate the study at any time for reasonable medical 
and/or administrative reasons. As far as possible, this should occur after mutual consultation. 
If the study is terminated prematurely by the sponsor, all subjects will be kept fully informed 
and an appropriate follow-up examination of the subjects will be arranged. The investigator 
will inform the institutional review board (IRB) of any premature termination or suspension 
of the study, where applicable. 

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5 Study Treatments 
5.1 Method of Assigning Subjects to Treatment Arms 
An interactive voice response system (IVRS) or an interactive web response system (IWRS) 
will be used for the randomization. Enrolled subjects who meet all of the inclusion and none 
of the exclusion criteria will be randomly assigned in a 1:1:1 ratio into one of three treatment 
arms. Randomization numbers will be assigned before administration of the study drug on 
Day -1. As it is known that the body weight and gender are potential impact factors on 
pharmacokinetic profile, the randomization to treatment assignment will be stratified by body 
weight (≥80 kg vs. <80 kg) as measured on Day -1, gender (male vs. female) and study 
center, considering that it is a multi-center study. 
5.2 Treatment Administered 
On Day 1, subjects who meet all of the inclusion and none of the exclusion criteria will be 
randomly assigned to one of three treatment arms according to the randomization scheme. 
The treatments arms are as follows: 
• Treatment Arm 1: CT-P17 (test), 40 mg/0.4ml (100 mg/mL) administered as a single SC 
injection via PFS 
• Treatment Arm 2: US-licensed Humira (reference), 40 mg/0.4ml (100 mg/mL) 
administered as a single SC injection via PFS 
• Treatment Arm 3: EU-approved Humira (reference), 40 mg/0.4ml (100 mg/mL) 
administered as a single SC injection via PFS 
All subjects will fast overnight (nothing to eat or drink except water) for at least 8 hours prior 
to study drug administration. Subjects will remain fasted for 4 hours after study drug 
administration. Water is permitted as desired except for the period 1 hour before and 1 hour 
after study drug administration.  
The study drug will be administered on the subject’s lower abdomen except for the 5 cm 
around the subject’s navel. Immediately after the study drug administration, a cotton ball or 
gauze pad will be pressed over the injection site and held it for 10 seconds without rubbing. 
The time of dose administration will be called “0” hour. 
5.3 Identity of Investigational Products 
The study drugs that will be used in this study are outlined in Table 5-1. 

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Table 5-1 
Identity of Study Drugs 
Product 
Supplied as: 
CT-P17 
Pre-filled syringe containing 100 mg/mL (40 mg/0.4 mL) of CT-
P17 
US-licensed Humira 
Pre-filled syringe containing 100 mg/mL (40 mg/0.4 mL) 
adalimumab 
EU-approved Humira 
Pre-filled syringe containing 100 mg/mL (40 mg/0.4 mL) 
adalimumab 
Dosing instruction described in the Humira prescribing information will be followed 
(Humira USPI 2018, Humira SmPC 2018). 
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized 
monoclonal antibody that is being developed as a similar biological medicinal product to the 
reference product, Humira. 
The company code of the product is CT-P17. The International Nonproprietary Name of the 
commercially available reference product (Humira) is adalimumab and the Anatomical 
Therapeutic Chemical Classification System code is L04AB04. CT-P17 is a full-length IgG1 
kappa isotype antibody with a total molecular weight of 148 kDa. 
The reference products, US-licensed Humira and EU-approved Humira, are supplied as a 
sterile, preservative-free solution of adalimumab for SC administration. Humira is a clear and 
colorless solution, with a pH of approximately 5.2 (Humira USPI 2018, Humira SmPC 
2018). 
CELLTRION, Inc. will provide adequate supplies of CT-P17 and Humira for distribution to 
the study centers. 
5.4 Management of Clinical Supplies 
5.4.1 Study Drug Packaging, Labeling, and Storage 
CELLTRION, Inc. will provide the investigator and study centers with adequate quantities of 
CT-P17, US-licensed Humira, and EU-approved Humira. A label will be attached to the 
outside of each subject kit, as well as to the immediate container. The text will be compliant 
with local regulatory requirements and may include some of the following information: 
• Protocol number 
• Subject number/study center number 

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• Contents and quantity 
• Lot number 
• Randomization code/kit number 
• Investigator’s name 
• Storage instructions 
• Caution statement (for study use only) 
• CELLTRION, Inc.’s contact name and address 
• Expiry date 
All study drug supplies will be stored in a secured area (e.g., a locked cabinet), protected 
from light. CT-P17, US-licensed Humira, and EU-approved Humira must be kept at a 
controlled refrigerated temperature between 2°C and 8°C and it will not be frozen. The 
immediate containers must be kept in the outer carton until use to protect the study drug from 
light. The recommended storage conditions, and expiry date where required, are stated on the 
product label approved by each regulatory authority. 
5.4.2 Study Drug Accountability, Dispensing and Destruction 
The investigator will maintain accurate records of receipt of all study drugs, including dates 
of receipt. In addition, accurate records will be kept regarding when and how much study 
drug is dispensed and used by each subject in the study. Reasons for departure from the 
expected dispensing regimen will also be recorded.  
The investigator agrees not to supply the study drug to any person other than sub-
investigators, designated staff, and the subjects participating in the study. Study drug may not 
be relabeled or reassigned for use by other subjects unless approved by CELLTRION, Inc. 
During the study, unused study drug syringes should be returned to the depot of origin. 
Accountability of the product must be completed at the site level and discrepancies, if any, 
need to be resolved prior to return. Only if it is written in SOPs or documentation in place, 
the used syringes can be destroyed locally. The list of destroyed syringes must be recorded. 
The investigator agrees to neither dispense the study drug from, nor store it at, any study 
center other than the study centers agreed upon with CELLTRION, Inc. 

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Details in study drugs accountability and destruction will be followed according to the 
pharmacy manual. 
5.5 Treatment Compliance 
Study drug will be administered at the study center and a designated personnel will confirm 
that the subject has received the entire dose of study drug. 
The date and time of study drug administration and the completion of dosing will be recorded 
in both the source documents and eCRF. Comments will be recorded if there are any 
deviations from the planned dosing procedures. 
5.6 Blinding 
The study will be performed in a double-blind manner.   
The randomization codes will not be revealed to study subjects, investigators, or study center 
personnel.  
5.6.1 
Breaking the Blind 
Under normal circumstances, the blind should not be broken. The blind should be broken 
only if specific emergency treatment would be dictated as knowing the study drug assignment 
is required for medical management. In such cases, the investigator may, in an emergency, 
determine the identity of the study drug by using the applicable procedure in the IWRS or 
IVRS (see study manual, which is provided as a separate document). 
The date, time and reason for the unblinding must be documented in the appropriate field of 
the eCRF and the medical monitor and/or the sponsor will be informed as soon as possible. 
All calls resulting in an unblinding event will be recorded and reported by the IWRS or IVRS 
to the medical monitor and/or the sponsor. Any subjects for whom the blind is broken may 
continue in the study. 
 pharmacovigilance (PVG) will have access to the randomization 
code, if suspected unexpected serious adverse reactions (SUSARs), which are subject to 
expedited reporting, should be unblinded before submission to the regulatory authorities, if 
required. 
The overall randomization code will be broken for reporting purposes after all subjects have 
completed the study and the database has been finalized for study completion. The 
randomization code will not be revealed to study subjects, study center personnel, or 
investigators.  

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5.7 Prior, Concomitant, and Prohibited Medications 
Information (e.g., drug name, date[s] of administration, etc) about prior medications taken by 
the subject within 30 days before he or she signs the ICF (inclusive of the applicable periods 
for prohibited medications as defined in Section 4.2) will be recorded in both the source 
documents and eCRF. 
Concomitant medication use will be recorded from the time the subject signs the ICF until the 
EOS visit. Concomitant medication use is permitted if indicated by the investigator for 
treatment of an AE. 
Prohibited medications during the study include the following: 
• Monoclonal antibody or fusion protein, or other biologic agent (including but not limited 
to TNF- α blockers) 
• Any other investigational drug except for the study drug used during this study 
• Live or live-attenuated vaccine during the study and 6 months after the study drug 
administration (Day 1). 
• OTC medications, prescription medications (excluding hormonal birth control), dietary 
supplements, or herbal remedies excluding the premedications or treatment of AEs. 
It is the investigator’s responsibility to ensure that details regarding the medication are 
adequately recorded in both the source documents and eCRF. Any changes in concomitant 
medications will also be recorded in both the source documents and eCRF. 
5.8 Subject Restrictions During the Study 
5.8.1 Food, Fluid, and Activity 
• Alcohol consumption will be avoided from 24 hours before any study visit and while 
subjects are confined to the study center. Subjects will abstain from alcohol-containing 
products for 24 hours prior to each PK sample time point. Subjects may undergo an 
alcohol breath test at the discretion of the investigator. Subjects will not exceed an alcohol 
consumption of 7 units per week during the study from time of signing the ICF through 
the EOS visit. 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. 
• Subjects will not be permitted to drink caffeine-containing products (e.g., coffee, black 
tea, cola) or use caffeine or xanthine-containing products for 48 hours prior to the 

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administration of the study drug and 24 hours prior to each PK sample time point. 
Subjects will not be permitted to use nicotine-containing products up to 24 hours after the 
study drug administration. At all times during the study, subjects will not consume more 
than 10 cigarettes per day (24 hours), or equivalent. 
• Strenuous activity (e.g., heavy lifting, weight training, calisthenics, and aerobics) is 
prohibited from 72 hours prior to Day -1 and 72 hours prior to each PK sample time 
point. Mild physical activity may be resumed after Day 7. 
• All subjects will fast (nothing to eat or drink except water) for at least 8 hours prior to 
study drug administration (Day 1). Subjects will remain fasted for 4 hours after study 
drug administration. Water is permitted as desired except for the period 1 hour before and 
1 hour after study drug administration. No outside food or drink is permitted at the study 
center. All meals and snacks while the subjects are confined will be provided by the study 
center. 
5.8.2 Contraception 
• 
Subject and their partner of childbearing potential must agree to use a highly effective 
method of contraception throughout the study and for 5 months after the administration 
of assigned treatment. Examples include the following:  
- 
Combined (estrogen and progestogen containing) or progestogen-only hormonal 
contraception associated with inhibition of ovulation 
- 
Intrauterine devices 
- 
True abstinence, when this is in line with the preferred and usual lifestyle of the 
subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-
ovulation methods), declaration of abstinence for the duration of exposure to 
investigational drug, and withdrawal are not acceptable methods of contraception. 
• 
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. 

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• Male subjects are not permitted to donate sperm or father a child within 5 months after 
administration of study drug. 

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6 Study Assessments and Procedures 
Before performing any study procedures, all potential subjects will sign and date an ICF. The 
investigator will address all questions raised by the subject before the subject signs the ICF. 
The investigator will also sign and date the ICF. Subjects will undergo study procedures at 
the time points specified in the schedule of assessments (Table 10-1). 
6.1 Pharmacokinetic Assessments 
Blood samples for PK assessments of CT-P17 and adalimumab will be collected from all 
subjects at the time points specified in the schedule of assessments (Table 10-1). Analysis of 
the samples will be performed at the central laboratory.  
The following serum PK parameters will be calculated for CT-P17 and adalimumab using 
actual sampling times rather than scheduled sampling times. 
Primary endpoints: 
• Area under the concentration-time curve from time zero to infinity (AUC0-inf) 
• Area under the concentration-time curve from time zero to the last quantifiable 
concentration (AUC0-last) 
• Maximum serum concentration (Cmax) 
Secondary endpoints: 
• Area under the concentration-time curve extrapolated from time zero to infinity as a 
percentage of total AUC (%AUCextrap) 
• Time to Cmax (Tmax) 
• Apparent volume of distribution during the terminal phase after non-intravenous 
administration (Vz/F) 
• Terminal elimination rate constant (λz) 
• Terminal elimination half-life (t1/2) 
• Apparent total body clearance (CL/F) 

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6.2 Safety Assessments 
Safety assessments will be performed on AEs (including serious AEs [SAEs]), AEs of special 
interest (AESI) (injection site reactions, hypersensitivity/allergic reactions, infections, and 
malignancies), immunogenicity, hypersensitivity/allergic reaction assessments by additional 
ECG and vital sign monitoring (including systolic and diastolic blood pressure, heart rate, 
respiratory rate, and body temperature), vital sign and weight measurement, ECG, physical 
examination, IGRA, chest X-ray, pregnancy testing, clinical laboratory testing (including 
hematology, chemistry, and urinalysis), local site pain using 100 mm VAS, signs and 
symptoms of TB, and prior and concomitant medications monitored throughout the study. 
Hepatitis B, hepatitis C, HIV status and syphilis will be tested for the subject’s eligibility 
determination. 
6.2.1 Adverse Events 
6.2.1.1 Definitions of Adverse Events 
The investigator is responsible for reporting all AEs that are observed or reported during the 
study, regardless of their relationship to study drug or their clinical significance.  
An AE is defined as any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related. Subjects will be instructed to contact the 
investigator at any time after the ICF was signed if any symptoms develop. 
A treatment-emergent AE (TEAE) is defined as any event not present before exposure to 
study drug or any event already present that worsens in severity or frequency after exposure 
to study drug. This includes any occurrence that is new in onset or aggravated in severity or 
frequency from the baseline condition; abnormal results of diagnostic procedures including 
laboratory test abnormalities are considered AEs if they fulfill the following: 
• Result in discontinuation from the study 
• Require treatment or any other therapeutic intervention 
• Require further diagnostic evaluation (excluding a repetition of the same procedure to 
confirm the abnormality) 
• Are associated with clinical signs or symptoms judged by the investigator to have a 
significant clinical impact 
Medical interventions such as surgery, diagnostic procedures, and therapeutic procedures are 
not AEs but the action taken to treat the medical condition. They should be recorded as 

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treatment(s) of the AEs. The event term of primary cause should be recorded and reported 
instead of the term of surgery, diagnostic procedure, or therapeutic procedure. 
6.2.1.1.1 
Adverse Events of Special Interest 
The following AESIs will be reported using the same process as for AEs: 
Injection site reactions 
Injection site reactions will be observed after study drug administration and assessed based 
on Common Terminology Criteria for Adverse Events (CTCAE) v5.0. All AEs related to 
injection site reaction including erythema, itching, hemorrhage, pain, and swelling will be 
reported. 
Hypersensitivity/allergic reactions 
All AEs related to hypersensitivity and allergic reactions occurring within 24 hours after the 
study drug administration will be reported. 
Infection 
All AEs related to infection including TB, sepsis, and other opportunistic infections will be 
reported. 
Malignancy 
All AEs related to malignancy including but not limited to the following: hepatosplenic T-cell 
lymphoma, leukemia, lymphoma, melanoma, and Merkel cell carcinoma. 
6.2.1.1.2 
Serious Adverse Events 
An SAE is defined as any untoward medical occurrence that at any dose: 
• Results in death 
• Is immediately life-threatening 
• Requires in-patient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity 
• Is a congenital anomaly/birth defect 

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Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered SAEs when, based upon appropriate medical judgment, 
they may jeopardize the subject or may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood 
dyscrasias or convulsions that do not result in in-patient hospitalization, or the development 
of drug dependency or drug abuse. 
6.2.1.1.3 
Suspected Unexpected Serious Adverse Reactions 
A suspected unexpected SAE is defined as an event of which the nature or severity is not 
consistent with the applicable product information (e.g., IB) for an unapproved 
investigational product or the label (e.g., package insert, SmPC, or prescribing information) 
for an approved product. Assessment of expectedness will be made with the use of the IB and 
the SmPC. Therefore, if a treatment-related SAE occurs and it was not mentioned in the 
applicable product information, then it will be reported as a SUSAR (Suspected Unexpected 
Serious Adverse Reaction). 
6.2.1.2 Eliciting and Documenting Adverse Events 
Adverse events will be assessed from the time the ICF is signed and until the end of the 
subject’s participation in the study. All AEs will be followed until resolution or improvement 
to baseline, death, confirmed by the investigator that no further improvement could be 
expected, no more collection of clinical or safety data, or final database closure. Adverse 
events of special interest (e.g., injection site reactions, hypersensitivity/allergic reactions, 
infections, and malignancies) will be closely monitored. 
Subjects will be asked a standard question to elicit any medically related changes in their 
well-being. They will also be asked if they have been hospitalized, had any accidents, used 
any new medications, or changed concomitant medication regimens (both prescription and 
OTC medications). 
In addition to subject observations, AEs will be documented from any data collected on the 
AE page of the eCRF (e.g., laboratory values, physical examination findings, ECG changes) 
or other documents that are relevant to subject safety. 
6.2.1.3 Reporting Adverse Events 
All AEs reported or observed during the study will be recorded in both the source documents 
and on the AE page of the eCRF. Information to be collected includes drug treatment, type of 
event, time of onset, action taken with study drug, investigator-specified assessment of 

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severity and relationship to study drug, time of resolution of the event, seriousness, as well as 
any required treatment or evaluations, and outcome. 
Adverse events resulting from concurrent illnesses, reactions to concurrent illnesses, 
reactions to concurrent medications, or progression of disease states will also be reported. 
Adverse events will be recorded according CTCAE v5.0. The Medical Dictionary for 
Regulatory Activities (MedDRA) will be used to code all AEs.  
Any medical condition that is present at the time that the subject is screened but does not 
deteriorate will not be reported as an AE. However, if it deteriorates at any time during the 
study, it will be recorded as an AE. 
The investigator’s assessment of an AE’s relationship to study drug is part of the 
documentation process, but it is not a factor in determining what is or is not reported in the 
study. If there is any doubt as to whether a clinical observation is an AE, the event will be 
reported. 
The severity and the relationship or association of the study drug in causing or contributing to 
the AE will be characterized as defined in Sections 6.2.1.5 and 6.2.1.6, respectively. 
Adverse events (and SAEs) should be reported until the EOS visit regardless of the 
relationship to the study drug. After the EOS visit, serious adverse drug reactions will be 
reported to CELLTRION, Inc. or its designee. 
6.2.1.4 Reporting Serious Adverse Events 
Any AE considered serious by the investigator or which meets SAE criteria (Section 
6.2.1.1.2) must be reported to 
 PVG and the sponsor immediately (within 24 hours after 
the study center staff first notices about the event).  
The following contact information is to be used for SAE reporting: 
 
 
 
 
 
 
 
 
Data entry should be completed in the remote data capture system by the investigator within 
24 hours of awareness of an SAE. In the event that this is not possible (e.g., system failure or 
access problems), the study center should complete an SAE report form and fax (or e-mail) it 

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to 
 PVG within 24 hours of awareness of the event. The remote data capture system 
should be updated as soon as it is available. If the subject is hospitalized during an SAE or 
because of an SAE, a copy of the hospital discharge summary will be faxed (or e-mailed) to 
 PVG as soon as it becomes available. Withdrawal from the study and all therapeutic 
measures will be at the discretion of the principal investigator or sub-investigator.  
CELLTRION, Inc. or its designee is responsible for reporting relevant SAEs to the competent 
authority, other applicable regulatory authorities, and participating investigators, in 
accordance with European Clinical Trials Directive (Directive 2001/20/EC), International 
Council for Harmonisation (ICH) guidelines, and/or local regulatory requirements. 
CELLTRION, Inc. or its designee is responsible for reporting fatal or life-threatening 
SUSARs, (expedited reports) to the regulatory agencies and competent authorities by 
telephone or fax within 7 calendar days after being notified of the event. CELLTRION, Inc. 
or its designee should report other relevant SAEs associated with the use of the study drug to 
the appropriate competent authorities (according to local guidelines), investigators, and 
central ethics committees by a written safety report within 15 calendar days of notification. 
Adverse events associated with hospitalization or prolongations of hospitalization are 
considered as SAEs. Any initial admission (even if less than 24 hours) to a healthcare facility 
meets these criteria. Admission also includes transfer within the hospital to an acute/intensive 
care unit (e.g., from the psychiatric wing to a medical floor, from medical floor to a coronary 
care unit, from neurological floor to a TB unit). 
Hospitalization or prolongation of hospitalization in the absence of a precipitating clinical AE 
is not in itself an SAE. Examples include the following: 
• Admission for treatment of a pre-existing condition not associated with the 
development of a new AE or worsening of the pre-existing condition (e.g., for work-
up of persistent pre-treatment laboratory abnormality) 
• Social admission (e.g., subject has no place to sleep) 
• Administrative admission (e.g., for yearly physical examination) 
• Protocol-specified admission during a study (e.g., for a procedure required by the 
study protocol) 
• Optional admission not associated with a precipitating clinical AE (e.g., for elective 
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• Hospitalization for observation without a medical AE 
• Hospitalization purely for convenience (e.g., for easier performance of study 
assessments) 
• Pre-planned treatments or surgical procedures; these should be noted in the baseline 
documentation for the entire protocol and/or for the individual subject 
6.2.1.5 Assessment of Severity 
The severity, or intensity, of an AE refers to the extent to which an AE affects the subject’s 
daily activities. The severity of the AE will be graded based on the CTCAE v5.0, based on 
the following general guidelines (a semicolon indicates “or” within each description): 
Grade 1: 
Mild AE (minor; no specific medical intervention; asymptomatic laboratory 
findings only; radiographic findings only; marginal clinical relevance) 
Grade 2: 
Moderate AE (minimal intervention; local intervention; noninvasive 
intervention [packing, cautery]) 
Grade 3: 
Severe and undesirable AE (significant symptoms requiring hospitalization or 
invasive intervention; transfusion; elective interventional radiological 
procedure; therapeutic endoscopy or operation) 
Grade 4: 
Life-threatening or disabling AE (complicated by acute, life-threatening 
metabolic or cardiovascular complications such as circulatory failure, 
hemorrhage, or sepsis; life-threatening physiological consequences; need for 
intensive care or emergent invasive procedure; emergent interventional 
radiological procedure, therapeutic endoscopy, or operation) 
Grade 5: 
Death related to AE 
Changes in the severity of an AE will be documented to allow an assessment of the duration 
of the event at each level of severity to be performed. If an AE upgrades in severity or, 
changes from non-serious to serious, a new AE needs to be reported. If an AE downgrades in 
severity, it should not be reported as a new AE. Adverse events characterized as intermittent 
do not require documentation of onset and duration of each episode. 
6.2.1.6 Assessment of Causality 
As discussed in Section 6.2.1.3, the investigator’s assessment of an AE’s relationship to study 
drug is part of the documentation process, but it is not a factor in determining what is or is not 

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reported in the study. If there is any doubt as to whether a clinical observation is an AE, the 
event will be reported. 
The relationship or association of CT-P17 or Humira in causing or contributing to the AE will 
be characterized using the following classification and criteria: 
Unrelated: 
This relationship suggests that there is no association between the study drug 
and the reported event. 
Possible: 
This relationship suggests that treatment with the study drug caused or 
contributed to the AE, i.e., the event follows a reasonable temporal sequence 
from the time of drug administration or follows a known response pattern to the 
study drug, but could also have been produced by other factors. 
Probable: 
This relationship suggests that a reasonable temporal sequence of the event 
with drug administration exists and, based upon the known pharmacological 
action of the drug, known or previously reported adverse reactions to the drug 
or class of drugs, or judgment based on the investigator’s clinical experience, 
the association of the event with the study drug seems likely. The event 
disappears or decreases on cessation or reduction of the dose of study drug. 
Definite: 
This relationship suggests that a definite causal relationship exists between drug 
administration and the AE, and other conditions (concurrent illness, 
progression/expression of disease state, or concurrent medication reaction) do 
not appear to explain the event. The event reappears or worsens if the study 
drug is re-administered. 
6.2.2 Other Safety Assessments 
6.2.2.1 Immunogenicity Assessment 
Immunogenicity of CT-P17, US-licensed Humira, and EU-approved Humira will be assessed 
at the time points indicated in the schedule of assessments (Table 10-1). 
The immunogenicity of CT-P17 and reference drugs will be assessed at baseline and 
post-treatment serum measures by a validated immunoassay. 
Samples will be drawn before dosing of study drug, at the same time as the clinical laboratory 
tests, where applicable. If the blood sample was unable to be analyzed or was missing, some 
blood samples collected for PK assessment at the same time point could be used for 

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immunogenicity assessment. Analysis of the samples will be performed at the central 
laboratory. 
6.2.2.2 Injection Site Reaction 
Injection site reactions will be assessed 30 minutes (±10 minutes) after study drug 
administration, as specified in the schedule of assessments (Table 10-1).  
Details will be recorded in both the source documents and the eCRF. 
6.2.2.3 Hypersensitivity/Allergic Reactions Monitoring 
Hypersensitivity/allergic reactions will be assessed by additional ECG and vital sign 
monitoring (including systolic and diastolic blood pressure, heart rate, respiratory rate, and 
body temperature), to monitor for possible hypersensitivity/allergic reactions, at the time 
points indicated in the schedule of assessments (Table 10-1). 
In addition, hypersensitivity/allergic reactions will be monitored by routine continuous 
clinical monitoring. In case of hypersensitivity, emergency medication and equipment, such 
as adrenaline, antihistamines, corticosteroids, and respiratory support including inhalational 
therapy, oxygen, and artificial ventilation will be available and an ECG can be performed. 
6.2.2.4 Vital Signs, Weight, and Height 
Vital signs will be measured at the time points indicated in the schedule of assessments 
(Table 10-1). The following vital signs will be measured: systolic and diastolic blood pressure 
(mmHg), heart rate (beats per minute), respiratory rate (breaths per minute), and body 
temperature (°C). Blood pressure and heart rate measurements will be performed after the 
subject has been resting for at least 5 minutes. All measurements will be documented at each 
visit. Details will be recorded in both the source documents and the eCRF. 
Vital sign measurements will also be monitored before and after study drug administration as 
part of the hypersensitivity monitoring (Section 6.2.2.2). 
Body weight and height will be measured according to the schedule of assessments 
(Table 10-1). 
6.2.2.5 Electrocardiogram 
Single 12-lead ECGs will be obtained after the subject has been in the supine position for at 
least 5 minutes at the time points indicated in the schedule of assessments (Table 10-1). 

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Electrocardiograms for hypersensitivity monitoring will be performed at 3 hours (±30 
minutes) after the administration of study drug and additional ECGs can be performed if the 
subject experiences cardiac symptoms. Either 3-lead or 12-lead ECGs can be used for 
hypersensitivity monitoring. If, following ECG review by the investigator, there are any ECG 
findings that would indicate cardiac insufficiency or QT prolongation, the subject will be 
referred to a cardiologist and the event will be recorded in the source documents and the 
eCRF. Regardless of the ECG result, further evaluation with a cardiologist can be performed 
depending on the investigator’s discretion. 
6.2.2.6 Physical Examinations 
A standard physical examination will be performed at the time points indicated in the 
schedule of assessments (Table 10-1).  
The physical examination includes an assessment of general appearance and a review of 
systems. Investigators will evaluate subjects for any indication of infections and injection site 
reactions in accordance with the investigator’s medical judgment. 
Information about the physical examinations will be recorded by the investigator or designee 
in both the source documents and the eCRF. Any abnormalities will be recorded in the source 
documents. Clinically significant findings and illnesses reported after the start of the study 
that meet the definition of an AE will be recorded as such in the source documents and eCRF. 
6.2.2.7 Tuberculosis Assessments 
At Screening, subjects with active TB, latent TB (defined as a positive result for IGRA with 
no active lesion in examination of chest X-ray without any sign or symptom of TB), a history 
of TB, or had close contact with a person with active TB within 8 weeks prior to 
administration of the study drug (Day 1) will not be enrolled in the study. 
Subjects will be monitored for the clinical signs and symptoms of TB throughout the study 
and until the EOS, as specified in the schedule of assessments (Table 10-1); IGRA and chest 
X-ray can be performed at the investigator’s discretion based on the judgment on the signs 
and symptoms of TB monitoring.  
6.2.2.7.1 
Chest X-ray 
A chest X-ray (both posterior–anterior and lateral views) will be performed at Screening as 
indicated in the schedule of assessments (Table 10-1). The results will be read by a qualified 
radiologist to specifically look for evidence of current or previous active or latent TB. The 
findings will be recorded in both the source documents and eCRF. 

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Radiographic findings suggestive of healed TB or active TB may include, but are not limited 
to, pulmonary nodules, fibrotic scars, calcified granulomas, upper lobe infiltrates, cavitations, 
and pleural effusions. The chest X-ray will be available to the investigator for review and any 
abnormal findings will be discussed with the medical monitor and sponsor before the 
administration of the study drug (Day 1). 
6.2.2.7.2 
Interferon-γ Release Assay 
An IGRA will be performed at Screening and at the EOS indicated in the schedule of 
assessments (Table 10-1).  
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. 
If the result of the IGRA is indeterminate after administration of the study drug, one retest 
will be possible. If the repeated IGRA test result is again indeterminate, the investigator will 
discuss and agree with the sponsor or its designee the next action to be taken. 
If the result of the IGRA is positive during the study, subjects will be referred to the clinicians 
immediately to be investigated for the presence of active TB based on medical history and 
any clinical signs and symptoms including chest X-ray result.  
The analysis will be performed at the local laboratory. 
6.2.2.8 Pregnancy 
A serum pregnancy test (β-human chorionic gonadotropin) will be performed on women of 
childbearing potential at Screening and EOS, as indicated in the schedule of assessments 
(Table 10-1). A urine pregnancy test will be performed on women of childbearing potential 
on Day -1. Only subjects with negative results for both serum pregnancy test at Screening and 
urine pregnancy test on Day -1 can be enrolled in the study. 
Throughout the study, a urine pregnancy test will be performed when there is any possibility 
of pregnancy, and a confirmatory serum pregnancy test will be performed if a urine 
pregnancy test result is positive.  
In an event of unexpected pregnancy during study participation and for 5 months after 
administration of the study drug, the subjects will be counselled to inform the investigator. If 
a female subject or the partner of a male subject becomes pregnant, the pregnancy must be 

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reported to CELLTRION, Inc. and 
 PVG within 24 hours of the study center’s 
knowledge of the pregnancy while confirmation is pending. The study center must complete 
the supplied pregnancy form (female subject or partner of a male subject) and return it to 
CELLTRION, Inc. and 
 PVG within 24 hours after acquisition of the consent for the 
pregnancy form. 
Pregnant subjects or the pregnant partners of male subjects will be followed until the end of 
the pregnancy (e.g., delivery, stillbirth, miscarriage) and the mother and the baby will be 
followed for 1 year after the birth, provided consent is obtained. Pregnancy alone will not be 
regarded as an AE unless there is a suspicion that the study drug may have interfered with the 
effectiveness of a contraceptive medication. Elective abortions without complications should 
not be handled as AEs, unless they are therapeutic abortions. Hospitalization for normal 
delivery of a healthy newborn should not be considered as SAE. Any SAE that occurs during 
pregnancy (e.g., maternal serious complications, therapeutic abortion, ectopic pregnancy, 
stillbirth, neonatal death, congenital anomaly, birth defect) must be reported within 24 hours 
in accordance with the procedure for reporting SAEs (Section 6.2.1.4). 
6.2.3 Hepatitis B, Hepatitis C, Human Immunodeficiency Virus and 
Nontreponemal Test 
At Screening, HBsAg, HBsAb, and HBcAb (total or IgG) will be assessed in all subjects 
(mandatory) as specified in the Table 6-1. If a subject has HBsAg negative, HBsAb negative 
or positive, and HBcAb (IgG or total) positive, a hepatitis B virus (HBV) DNA test will be 
performed at Screening and its result will be used to determine the eligibility.  

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Table 6-1 
Eligibility Based on Serology Markers for Hepatitis B Infection 
Test results 
Eligibility 
HBsAg 
HBsAb 
HBcAb 
HBV DNA 
+ 
+/– 
+/– 
Not applicable 
Not eligible 
– 
+/– 
+ 
+ 
Not eligible 
- 
Eligible 
– 
+/– 
– 
Not applicable 
Eligible 
Abbreviations: HBcAb, hepatitis B core antibody; HBsAb, hepatitis B surface antibody; HBsAg, hepatitis B 
surface antigen; HBV, hepatitis B virus. 
As specified in Table 6-1, the subject enrollment will be based on the test results. 
Hepatitis C antibody (HCAb) test, HIV (HIV-1 and HIV-2) tests and nontreponemal test will 
be performed at Screening in all subjects (mandatory). If any of those test results is positive, 
the subject will be excluded from the study. 
6.2.4 Clinical Laboratory Testing 
Blood and urine samples for clinical laboratory assessments will be collected at the time 
points indicated in the schedule of assessments (Table 10-1) and will be prepared using 
standard procedures. The analysis will be performed at the local laboratory. 
The following clinical laboratory assessments will be performed: 
Hematology: 
Hematocrit, hemoglobin, red blood cell (RBC) count, white 
blood cell (WBC) count with differential, absolute neutrophil 
count, platelets 
Serum Chemistry: 
Albumin, alkaline phosphatase (ALP), alanine aminotransferase 
(ALT), aspartate aminotransferase (AST), blood urea nitrogen 
(BUN), calcium, chloride, total cholesterol, creatine 
phosphokinase (CPK), creatinine, creatine kinase–myocardial 
band isoenzyme (CK-MB), creatinine clearance (CrCl) 
[estimated by Modification of Diet in Renal Disease formula], 
C-reactive protein , gamma glutamyl transferase (GGT), 
glucose, lactate dehydrogenase (LDH), magnesium, potassium, 
sodium, total bilirubin, total protein, uric acid, direct bilirubin, 
triglycerides, inorganic phosphorus, high-density lipoprotein 
(HDL) cholesterol, Troponin I 

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Urinalysis: 
Color, pH, specific gravity, ketones, protein, glucose, bilirubin, 
nitrite, urobilinogen, occult blood, and microscopic examination 
Serology: 
Anti-HIV (HIV-1 and HIV-2) antibodies, hepatitis B surface 
antigen (HBsAg), hepatitis B surface antibody (HBsAb), 
hepatitis B core antibody (HBcAb [total or IgG]), HBV DNA, 
hepatitis C antibody (HCAb), nontreponemal (e.g., Rapid 
Plasma Reagin) tests 
Urine drug, alcohol, and 
nicotine: 
Tetrahydrocannabinol (THC) (or other metabolite to screen 
cannabis), opiates (OPI), cocaine (COC), methamphetamine 
(MET), barbiturates (BAR), and benzodiazepines (BZO). The 
history of drug abuse, alcohol and nicotine will be checked by 
medical history taking by the Investigator during the Screening 
period and Baseline (Day -1). 
Creatinine clearance will be calculated using serum creatinine level only at screening for 
inclusion. The result will be considered for inclusion by the discretion of the investigator, and 
it will be recorded on source document and eCRF. 
Any value outside the normal range will be flagged for the attention of the investigator or the 
sponsor at the study center. The investigator will indicate whether or not the value is 
clinically significant. If the result of the screening is indicated as clinically significant 
abnormal value, the subject will NOT be allowed into the study without permission of the 
sponsor. However, retest is permitted only once during screening period by the Investigator’s 
judgment. Additional testing during the study may be performed if medically indicated. If a 
clinically significant abnormality defined as per Section 6.2.1 is found in the samples taken 
after dosing, during the study, and/or at the EOS visit, it should be recorded as an AE and the 
study subject will be followed up until the test(s) has (have) normalized or stabilized. 
6.2.5 Local Site Pain 
Local site pain will be assessed using 100 mm VAS immediately (within 15 minutes) after 
study drug administration (Day 1) according to the schedule of assessments (Table 10-1). 
Subjects will be asked to indicate their current level of pain intensity by drawing a single 
vertical line (│) on the 100 mm line (Appendix 10.2). 

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6.3 Sample Collections, Storage and Shipment 
6.3.1 Sample Collections  
The total volume of blood collected for each assessment is discussed in each specific 
laboratory manual. The sample collection tube may be changed during the study and details 
will be provided in the laboratory manual. 
6.3.1.1 Pharmacokinetic Sampling 
Blood will be collected per blood sampling time points for PK assessment sample at the time 
points specified in the schedule of assessments (Table 10-1). All samples will be collected as 
close as possible to the scheduled time point, and the actual sampling time will be recorded. 
Explanation will be provided in the eCRF for missed or mishandled samples and for samples 
collected outside the specified time windows.  
Samples should be stored and shipped as detailed in the laboratory manual. 
6.3.1.2 Interferon-γ Release Assay 
Blood samples for IGRA will be obtained at the time points specified in the schedule of 
assessments (Table 10-1). 
6.3.1.3 Clinical Laboratory Testing 
Blood samples for routine safety (clinical laboratory testing) will be collected for analysis 
throughout the study at the time points specified in the schedule of assessments (Table 10-1). 
An additional blood for hepatitis B and C, HIV (HIV-1, HIV-2) and nontreponemal tests will 
also be required at Screening. A serum pregnancy test sample will be required at Screening 
and at the EOS visit for women of childbearing potential who have not been surgically 
sterilized.  
6.3.1.4 Immunogenicity Sampling 
Blood samples for immunogenicity assessments will be obtained at the time points specified 
in the schedule of assessments (Table 10-1). 
Samples should be stored and shipped as detailed in the laboratory manual. 

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6.4 Labeling, Storage, and Transportation of Samples 
6.4.1 Sample Labeling 
Each sample tube will be clearly labeled with the following information: study number, 
subject number, tube identification, and scheduled sampling time point. 
6.4.2 Sample Storage and Shipment 
During the study, blood samples will be collected for PK and immunogenicity, analyses. 
Where appropriate, the serum should be transferred into a sufficient number of transfer tubes 
for transport to assigned testing facilities. Primary and back-up samples will be shipped to the 
central laboratory according to the laboratory manual, and primary samples should be 
shipped separately from the back-up samples. 
Additionally, back-up samples for PK and immunogenicity should be retained at the central 
laboratory as a backup for up to 5 years after the end of the study in case additional analysis 
is required. If additional analysis for PK and immunogenicity is not required, the samples will 
be stored at CELLTRION, Inc. or a designated biobank for a further 5 years (from the date 
the sample is transferred to the biobank) unless a specific authorization is given by 
CELLTRION, Inc. to destroy the sample. Additional tests can be conducted at CELLTRION, 
Inc. or the biobank if it is required from a regulatory or medical perspective. Details in 
storage and shipment will be followed according to the laboratory manual. 

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7 Statistical Analysis Plan 
The statistical analysis will be performed using 
 
The statistical methods for this study will be 
described in a detailed statistical analysis plan (SAP), which will be finalized before locking 
of the database. Changes from analyses planned in this protocol will be documented in the 
SAP. Any deviations from the planned analysis as described in the SAP will be justified and 
recorded in the final clinical study report (CSR). 
For categorical variables, frequencies and percentages will be presented. Continuous 
variables will be summarized using descriptive statistics (number of subjects, mean, standard 
deviation [SD], median, minimum, and maximum). 
7.1 Study Population 
7.1.1 Disposition of Subjects 
The number and percentage of subjects entering and completing the clinical study will be 
presented by treatment arm. 
The number of subjects who enroll in the study and the number and percentage of subjects 
who complete the study will be presented. Frequency and percentage of subjects who 
withdraw or discontinue from the study, and the reason for withdrawal or discontinuation, 
will also be summarized. 
7.1.2 Protocol Deviations 
Deviations from the protocol, including deviations of inclusion/exclusion criteria, will be 
defined as “minor” or “major” before overall code breaking. 
7.1.3 
Analysis Populations 
Intent-to-treat (ITT) Population: The ITT population is defined as all subjects enrolled and 
randomly assigned to receive a dose of any study drug, regardless of whether or not any study 
drug dosing was completed. Subjects will be assigned to treatment arms based on 
randomization. 
All study population analyses, including disposition of subjects, protocol deviations, and 
analysis populations as well as demographic and background characteristics will be analyzed 
using the ITT Population. 

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Pharmacokinetic Population: The PK population will include subjects who receive a 
complete dose of study drug and provide at least 1 post-treatment serum concentration with a 
concentration above the lower limit of quantification. Subjects in the PK population will be 
analyzed according to the treatment they received. 
Safety Population: The safety population will include all randomized subjects who receive a 
complete or partial dose of study drug. Subjects will be assigned to treatment arms based on 
treatment actually received. 
7.2 Pharmacokinetic Analyses 
All PK analyses will be conducted based on the PK population. The primary and secondary 
PK parameters of CT-P17 and adalimumab will be analyzed using non-compartmental 
methods based on the actual sampling time points. All parameters will be calculated using 
 
7.2.1 Primary Pharmacokinetic Analyses 
The primary PK parameters, AUC0-inf, AUC0-last, and Cmax, will be presented in data listings 
and summarized by treatment using the following descriptive statistics: number of subjects, 
mean, SD, median, minimum, maximum, geometric mean, and coefficient of variation (CV). 
Additionally, primary PK parameters will be summarized by treatment and anti-drug antibody 
status. 
For primary endpoints, the statistical analysis of the log-transformed primary endpoints 
(AUC0-inf, AUC0-last, and Cmax) will be based on an analysis of covariance model with 
treatment as a fixed effect and body weight (≥80 kg vs. <80 kg) as measured on baseline 
(Day -1), gender (male vs. female) and study center as covariates. The similarity of PK 
between; CT-P17 vs. US-licensed Humira, CT-P17 vs. EU-approved Humira, and US-
licensed Humira vs. EU-approved Humira will be concluded if the 90% CIs for ratios of 
geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, 
AUC0-last, and Cmax. 
7.2.2 Secondary Pharmacokinetic Analyses 
Serum concentration data will be presented in data listings and summarized by time point for 
each treatment using the following descriptive statistics: number of subjects, mean, SD, 
median, minimum, maximum, geometric mean, and CV.  

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The secondary PK parameters, %AUCextrap, Tmax, Vz/F, λz, t1/2, and CL/F, will be also 
presented in data listings and summarized by treatment using the following descriptive 
statistics: number of subjects, mean, SD, median, minimum, maximum, geometric mean, and 
CV.  
Additional PK analyses may be performed as detailed in the SAP. 
7.3 Safety Analyses 
7.3.1 Demographic, Baseline, and Background Characteristics 
Baseline demographic and background variables will be summarized by treatment arm using 
the ITT population.  
Demographics (including age, gender, ethnicity and race) and baseline and background 
characteristics will be presented in summary tables. Qualitative data (e.g., medical history) 
will be summarized in contingency tables, and quantitative data (e.g., age) will be 
summarized using quantitative descriptive statistics. 
7.3.2 Adverse Events 
Adverse events will be recorded according to the CTCAE v5.0 and will be coded to system 
organ class (SOC) and preferred term (PT) according to MedDRA. A TEAE is defined as 
described in Section 6.2.1.1. The following AE summaries will be reported by SOC, PT, and 
treatment arm, as appropriate: 
• Number and percentage of subjects reporting at least 1 TEAE 
• Number and percentage of subjects reporting at least 1 treatment-emergent SAE 
• Number and percentage of subjects discontinuing the study drug due to a TEAE 
• Number and percentage of subjects with AESIs (injection site reactions, 
hypersensitivity/allergic reactions, infections, and malignancies) 
All AE data will be presented in the data listings, and additional TEAE analyses may be 
performed as detailed in the SAP. 

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7.3.3 Immunogenicity Analysis 
Immunogenicity test results will be summarized by treatment arm and presented in a data 
listing. 
7.3.4 Clinical Laboratory Test 
Actual values and changes from Baseline for clinical laboratory test results will be 
summarized by treatment arm at each time point using descriptive statistics (number of 
subjects, mean, SD, median, minimum, and maximum). Shift tables will be generated for 
clinical laboratory test results. 
Individual clinical laboratory test results will be presented in data listings. 
7.3.5 Electrocardiogram, Physical Examination, and Vital Signs 
Actual values and change from Baseline for vital sign measurements will be summarized by 
treatment arm at each time point using descriptive statistics (number of subjects, mean, SD, 
median, minimum, and maximum). 
Shift tables comparing the categorical investigator interpretation of 12-lead ECGs and 
physical examinations at each scheduled post-baseline time point with those at Baseline will 
be summarized by treatment arm. 
Individual 12-lead ECG results and the investigator’s interpretation, physical examination 
findings, and vital sign measurements (including hypersensitivity monitoring) will be 
presented in data listings. 
7.3.6 Tuberculosis Assessments 
Results from TB screening and monitoring will be summarized by treatment arm and 
presented in data listings. 
7.3.7 Local Site Pain 
Individual local site pain (VAS) results will be summarized by treatment arm after the study 
drug administration using descriptive statistics (number of subjects, mean, SD, median, 
minimum, and maximum). 
Individual local site pain (VAS) results will be presented in a data listing. 

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7.3.8 Prior and Concomitant Medications 
Prior and concomitant medications will be coded using the WHO Drug Dictionary (WHO-
DD). All prior and concomitant medications data will be listed and summarized by treatment 
arm as appropriate. 
7.4 Sample Size Calculations 
A sample size of 91 subjects from each arm will provide at least 90% power to show 
similarity in PK; CT-P17 vs. US-licensed Humira, CT-P17 vs. EU-approved Humira and US-
licensed Humira vs. EU-approved Humira using 90% CI approach based on 80% to 125% 
equivalence margin, expected geometric mean ratio of 1.0 and CV of 48%, which is assumed 
based upon historical PK data in healthy subjects. 
The sample size is calculated from a two one-sided alpha level of 0.05. Approximately 
306 enrolled subjects (102 in each arm) are expected to yield at least 273 evaluable subjects 
(91 in each arm) with a 10% drop-out rate. By assuming that the primary PK parameters are 
highly correlated, the Type I/II error adjustment for multiplicity correction is not considered. 
7.5 Interim Analyses 
No formal interim analyses will be performed in this study. 
7.6 Data Quality Assurance 
This study will be conducted according to the ICH E6 (R2) risk and quality processes 
described in the applicable procedural documents. The quality management approach to be 
implemented in this study will be documented and will comply with the current ICH Good 
Clinical Practice guidelines on quality and risk management. 
Steps to be taken to ensure the accuracy and reliability of data include the selection of 
qualified investigators and appropriate study centers, review of protocol procedures with the 
investigator and associated staff before the study, periodic monitoring visits by CELLTRION, 
Inc. or its designee, and direct transmission of data from a central laboratory into the clinical 
database. The eCRFs will be reviewed for accuracy and completeness by the monitor during 
on-site monitoring visits and after their return to CELLTRION, Inc. or its designee; any 
discrepancies will be resolved with the investigator or designees, as appropriate. The data will 
be entered into the clinical study database and verified for accuracy. 
Quality assurance staff from CELLTRION, Inc. or its designee may visit the study center to 
carry out an audit of the study in compliance with regulatory guidelines and company policy. 
Such audits will require access to all study records, including source documents, for 

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inspection and comparison with the eCRF. Subject privacy must, however, be respected. 
Sufficient prior notice will be provided to allow the investigator to prepare properly for the 
audit. 
Similar auditing procedures may also be conducted by agents of any regulatory body 
reviewing the results of this study in support of a licensing application. The investigator 
should immediately notify CELLTRION, Inc. or its designee if he or she has been contacted 
by a regulatory agency concerning an upcoming inspection. 

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8 Investigator’s Obligations 
The following administrative items are meant to guide the investigator in the conduct of the 
study but may be subject to change based on industry and government SOPs, working 
practice documents, or guidelines. Changes will be reported to the IRB but will not result in 
protocol amendments. 
8.1 Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain subject confidentiality. All records will be kept in a secure 
storage area with limited access. Clinical information will not be released without the written 
permission of the subject, except as necessary for monitoring and auditing by the sponsor, its 
designee, regulatory authority(ies), or the IRB. 
The investigator, all employees and coworkers involved with this study may not disclose or 
use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the 
study. Prior written agreement from the sponsor or its designee must be obtained for the 
disclosure of any said confidential information to other parties. 
8.2 Institutional Review Board 
Regulatory authority regulations and the ICH guidelines require that approval be obtained 
from an IRB before participation of human subjects in research studies. Before study onset, 
the protocol, ICF, advertisements to be used for the recruitment of study subjects, and any 
other written information regarding this study to be provided to the subject must be approved 
by the IRB. Documentation of all IRB approvals and of the IRB compliance with the ICH 
harmonised tripartite guideline E6 (R2): Good Clinical Practice guidelines will be maintained 
by the site and will be available for review by the sponsor or its designee. 
All IRB approvals will be signed by the IRB chairman or designee and must identify the IRB 
name and address, the clinical protocol by title or protocol number or both and the date 
approval or a favorable opinion was granted. 
The investigator is responsible for providing written summaries of the progress and status of 
the study at intervals not exceeding 1 year or otherwise specified by the IRB. The investigator 
must promptly supply the sponsor or its designee, the IRB, and, where applicable, the 
institution, with written reports on any changes significantly affecting the conduct of the 
study or increasing the risk to subjects. 

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8.3 Subject Information and Consent 
Written informed consent in compliance with local regulatory authority requirements shall be 
obtained from each subject before he or she enters the study or before performing any 
unusual or nonroutine procedure that involves risk to the subject. If any institution-specific 
modifications to study-related procedures are proposed or made by the site, the consent will 
be reviewed by the sponsor or its designee or both before IRB submission. Once reviewed, 
the investigator will submit the ICF to the IRB for review and approval before the start of the 
study. If the ICF is revised during the course of the study, all active participating subjects 
must sign and date the revised form. 
Before recruitment and enrollment, each prospective subject will be given a full explanation 
of the study and be allowed to read the approved ICF. Once the investigator is assured that 
the subject understands the implications of participating in the study, the subject will be asked 
to give his or her consent to participate in the study by signing the ICF. A copy of the ICF will 
be provided to the subject. 
8.4 Financial Disclosure and Obligations 
The investigator is required to provide financial disclosure information to allow the sponsor 
to submit the complete and accurate certification or disclosure statements required under 
local regulations. In addition, the investigator must provide to the sponsor a commitment to 
promptly update this information if any relevant changes occur during the course of the 
investigation and for 1 year following the completion of the study. 
Neither the sponsor nor 
 is financially responsible for further testing or treatment of any 
medical condition that may be detected during the screening process. In addition, in the 
absence of specific arrangements, neither the sponsor nor 
 is financially responsible for 
further treatment of the subject’s disease. 
8.5 Investigator Documentation 
Prior to beginning the study, the investigator will be asked to comply with ICH E6 (R2) 8.2 
and local regulations by providing the following essential documents, including but not 
limited to: 
• IRB approval, 
• An original investigator-signed investigator agreement page of the protocol, 

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• Curriculum vitae for the principal investigator and each sub-investigator listed on Form 
FDA 1572. Current licensure must be noted on the curriculum vitae. Curriculum vitae 
will be signed and dated by the principal investigators and sub-investigators at study 
start-up, indicating that they are accurate and current, 
• Financial disclosure information to allow the sponsor to submit complete and accurate 
certification or disclosure statements required under local regulations. In addition, the 
investigators must provide to the sponsor a commitment to promptly update this 
information if any relevant changes occur during the course of the investigation and for 
1 year after the completion of the study, 
• An IRB-approved ICF, samples of site advertisements for recruitment for this study, and 
any other written information about this study that is to be provided to the subject or legal 
guardians, and 
• Laboratory certifications and reference ranges for any local laboratories used by the site, 
in accordance with local regulations. 
8.6 Study Conduct 
The investigator agrees to perform all aspects of this study in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki, ICH E6 (R2): Good Clinical 
Practice, the protocol, and all national, state, and local laws or regulations. 
8.7 Data Collection 
8.7.1 
Electronic Case Report Forms and Source Documents 
It is the intent of this study to acquire study data via electronic format. As part of the 
responsibilities assumed by participating in the study, the principal investigator or 
sub-investigator agrees to maintain adequate case histories for the subjects treated as part of 
the research under this protocol. The principal investigator or sub-investigator agrees to 
maintain source documentation (e.g., laboratory reports), enter subject data into the eCRF as 
accurately as possible, and respond to any reported discrepancies rapidly. These source 
documents may include diaries, laboratory reports, ECG strips, etc. 
The analysis data sets will be a combination of these data and data from other sources 
(e.g., laboratory data). 
The eCRFs are accessed through the appropriate system, which allows for on-site data entry 
and data management. Study center users can read from and write to the sponsor’s database 

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where the clinical data are collected. This provides immediate, direct data transfer to the 
database, as well as immediate detection of discrepancies, enabling study center coordinators 
to resolve and manage discrepancies in a timely manner. 
Each study center staff involved with the study at each study center will have an individual 
logon and password that allow for record traceability. Thus, the system, and subsequently any 
investigative reviews, can identify coordinators, investigators, and individuals who have 
entered or modified records. 
8.8 Adherence to Protocol 
The investigator agrees to conduct the study as outlined in this protocol in accordance with 
ICH E6 (R2) and all applicable guidelines and regulations. 
8.9 Adverse Events and Study Report Requirements 
By participating in this study, the investigator agrees to submit reports of SAEs according to 
the timeline and method outlined in the protocol. In addition, the investigator agrees to 
submit annual reports to his or her IRB as appropriate. If required by applicable local 
regulations, the investigator shall promptly notify the relevant IRB (in addition to the 
sponsor) of any SAE (including follow-up SAEs) and SUSARs that occurred at his/her site. 
He/she shall verify that the IRB acknowledges receipt of the information. The investigator 
also agrees to provide the sponsor with an adequate report, if applicable, shortly after 
completion of the investigator’s participation in the study. 
8.10 Investigator’s Final Report 
Upon completion of the study, the investigator, where applicable, will inform the institution; 
the investigator/institution will provide the IRB with a summary of the study’s outcome, and 
the sponsor and regulatory authority(ies) with any reports required. 
8.11 Records Retention 
All correspondence (e.g., with sponsor, IRB, or clinical research associates) relating to this 
clinical study will be kept in appropriate file folders. Records of subjects, source documents, 
eCRFs, and drug inventory sheets pertaining to the study must be kept on file. 
Essential documents will be retained until at least 15 years after the date on which the results 
of the study are submitted to the regulatory authorities in support of an allocation for a 
research or marketing permit, or completion date for study by approval or disapproval of any 
application, whichever is later. These documents will be retained for a longer period, 
however, if required by the applicable regulatory requirements or by an agreement with the 

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sponsor. It is the sponsor’s responsibility to inform the investigator/institution as to when 
these documents no longer need to be retained. 
If an investigator moves, withdraws from an investigation, or retires, the responsibility for 
maintaining the records may be transferred to another person, who will accept the 
responsibility. Notice of transfer is recommended to be made and agreed upon by the sponsor. 
8.12 Subject Identification Register 
The investigator agrees to complete a subject identification register, which will be used for 
the purpose of long-term follow-up, if needed. This form will be treated as confidential and 
will be filed by the investigator in the Study Center Master File. Otherwise, all reports and 
communications relating to the study will identify subjects by assigned number only. 
8.13 Publications 
After completion of the study, the data may be considered for reporting at a scientific meeting 
or for publication in a scientific journal. In these cases, the sponsor will be responsible for 
these activities and may work with the investigators to determine how the manuscript is 
written and edited, the number and order of authors based on SOPs of CELLTRON, Inc., the 
publication to which it will be submitted, and any other related issues. The sponsor has final 
approval authority over all such issues. 
Data are the property of the sponsor and cannot be published without their prior 
authorization, but data and any publication thereof will not be unduly withheld. 

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9 Study Management 
9.1 Monitoring 
9.1.1 
Data and Safety Monitoring Board 
An independent data and safety monitoring board will not be used for this study.  
9.1.2 
Monitoring of the Study 
The clinical monitor, as a representative of the sponsor, is obligated to follow the study 
closely. In doing so, the monitor will visit the investigator and study center at periodic 
intervals in addition to maintaining necessary telephone and email contact. The monitor will 
maintain current personal knowledge of the study through observation, review of study 
records and source documentation, and discussion of the conduct of the study with the 
investigator and staff. 
All aspects of the study will be carefully monitored by the sponsor or its designee for 
compliance with applicable government regulation with respect to current ICH E6 (R2) 
guidelines and SOPs. 
9.1.3 
Inspection of Records 
The investigator and institution involved in the study will permit study-related monitoring, 
audits, IRB review, and regulatory inspections by providing direct access to all study records. 
In the event of an audit, the investigator agrees to allow the sponsor, their representatives, or 
regulatory agency access to all study records. 
The investigator will promptly notify the sponsor and study center(s) of any audits scheduled 
by any regulatory authorities. 
9.2 Management of Protocol Amendments and Deviations 
9.2.1 
Modification of the Protocol 
Before the beginning of the study, the clinical study protocol and other relevant documents 
will be approved by the IRB, in accordance with local legal requirements. The sponsor must 
ensure that all ethical and legal requirements have been met before the first subject is enrolled 
in the study. 
This protocol must be followed exactly. To change the protocol, amendments must be written, 
which must be released by the responsible staff and receive IRB approval prior to 
implementation as appropriate. 

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9.2.2 
Protocol Deviations 
The investigator or designee will document and explain in the subject’s source documentation 
any deviation from the approved protocol. The investigator may implement a deviation from, 
or a change to, the protocol to eliminate an immediate hazard to study subjects without prior 
IRB approval. As soon as possible after such an occurrence, the implemented deviation or 
change, the reasons for it, and any proposed protocol amendments will be submitted to the 
IRB for review and approval, to the sponsor for agreement, and to the regulatory authorities, 
if required. 
A deviation from the protocol is an unintended or unanticipated departure from the 
procedures or processes approved by the sponsor and the IRB and agreed to by the 
investigator. A significant deviation occurs when there is nonadherence to the protocol by the 
subject or investigator that results in a significant and additional risk to the subject’s rights, 
safety and well-being. Significant deviations can include nonadherence to inclusion or 
exclusion criteria, or nonadherence to a regulatory agency’s regulations or ICH Good Clinical 
Practice guidelines, and will lead to the subject being withdrawn from the study (Section 4.3). 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. The investigator will be notified in writing by the monitor of deviations. 
The IRB will be notified of all protocol deviations, if appropriate, in a timely manner. 
9.3 Study Termination 
Although the sponsor has every intention of completing the study, they reserve the right to 
discontinue it at any time for clinical or administrative reasons. 
The end of the study is defined as the date on which the final database is locked. 
9.4 Final Report 
Whether the study is completed or prematurely terminated, the sponsor will ensure that one 
CSR will be prepared and provided to the regulatory agency(ies) as required by the applicable 
regulatory requirement(s). The sponsor will also ensure that CSRs in marketing applications 
meet the standards of the ICH harmonised tripartite guideline E3: Structure and content of 
CSRs. 

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10 Appendices 
10.1 Appendix: Schedule of Assessments 

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Table 10-1 
Schedule of Assessments 
 
Screening1 
Study Period2 
EOS3 
Study day (Visit windows) 
-28 to -2 
-1 
1 
2 
3 
4 
5 
5.5 
6 
6.5 
7 
8 
9 
15 
22 
29 
(±1) 
43 
(±1) 
57 
(±1) 
71 
(±1) 
Procedure 
 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion / exclusion criteria4 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Body weight & height5 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Physical examination 
X 
X 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Hepatitis B/C, HIV and syphilis 
test6 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TB screening (chest X-ray and 
IGRA)7 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(X) 
Serum pregnancy test8 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Urine pregnancy test8 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine drug abuse / alcohol / 
cotinine check9 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical laboratory tests10 
X 
X 
 
 
X 
 
 
 
 
 
 
X 
 
X 
 
X 
X 
X 
X 
Vital signs11 
X 
X 
X 
X 
X 
 
 
 
 
 
 
X 
 
X 
 
X 
X 
X 
X 
12-Lead ECG 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Administration of study drug12 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pharmacokinetic sampling13 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Immunogenicity sampling14 
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
X 
X 
Hypersensitivity monitoring15 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Injection site reaction16 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
VAS local site pain17 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior, concomitant medications18 
X 
Adverse events19 
X 
TB clinical monitoring7 
X 

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Abbreviations: ECG, electrocardiogram; EOS, End-of-Study; HIV, human immunodeficiency virus; IGRA, interferon-γ release assay; TB, tuberculosis; VAS, visual analogue scale. 
1. 
During the screening period, retest for screening is permitted only once by the Investigator’s judgment. If the repeated test result is again not suitable or indeterminate for 
inclusion, the subject will be screen failed. 
2. 
Subjects will be confined to the study center until completion of the 48-hour assessments after the administration of the study drug (Day 1) and admission can be extended 
depending on the subject’s and study center’s availability, up to Day 7. The consecutive study visits will be carried out on an out-patient basis. 
3. 
All EOS assessments will be performed on Day 71, for all subjects including those who discontinued prematurely. 
4. 
Inclusion and exclusion criteria should be confirmed before Day -1. On the Day -1, recheck process will be performed. 
5. 
Height will be measured at Screening only. 
6. 
Serology tests will be performed at the Screening visit for anti-HIV (HIV-1 and HIV-2) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), 
hepatitis B core antibody (HBcAb [total or IgG]), HBV DNA (if subject has HBsAg negative, HBsAb negative or positive, and HBcAb positive), hepatitis C antibody (HCAb), 
and nontreponemal (e.g., Rapid Plasma Reagin) tests. 
7. 
At Screening, a chest X-ray, an IGRA, and signs and symptoms of TB clinical monitoring will be performed. If the result of IGRA is indeterminate at Screening, a retest will 
be allowed only once during the Screening period. Additional IGRA test and chest X-ray will be performed if symptoms raise a suspicion of TB upon the judgement of the 
investigator during the study and until the EOS. Only IGRA will be performed at the EOS visit; signs and symptoms of TB clinical monitoring will be performed throughout 
the study and until the EOS. 
8. 
A serum pregnancy test on women of childbearing potential will be performed at Screening and the EOS visit. A urine pregnancy test will be performed in women of childbearing 
potential on Day -1. Throughout the study, a urine pregnancy test will be performed when there is any possibility of pregnancy, and a confirmatory serum pregnancy test will 
be performed if a urine pregnancy test result is positive. 
9. 
Urine drug screen (tetrahydrocannabinol, opiates, cocaine, methamphetamine, barbiturates and benzodiazepines) and history check by the investigator will be performed for 
drug abuse, alcohol, and cotinine check in Screening and Day -1. 
10. Clinical laboratory tests will be carried out: Hematology (hematocrit, hemoglobin, red blood cell count, white blood cell count with differential, absolute neutrophil count, 
platelets), Clinical chemistry (albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, calcium, chloride, total cholesterol, 
creatine phosphokinase, creatinine, creatine kinase–myocardial band isoenzyme [CK-MB], creatinine clearance [estimated by Modification of Diet in Renal Disease formula], 
C-reactive protein, gamma-glutamyl transferase, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total bilirubin, total protein, uric acid, direct bilirubin, 
triglycerides, inorganic phosphorus, high-density lipoprotein cholesterol, Troponin I), Urinalysis (color, pH, specific gravity, ketones, protein, glucose, bilirubin, nitrite, 
urobilinogen, occult blood, and microscopic examination). Creatinine clearance will be calculated using serum creatinine level only at screening for inclusion. 
11. Vital sign measurement on Day 1 will be performed before the start of the study drug administration (within 30 minutes). Additional vital signs will be measured after the study 
drug administration. On Day 1 (pre-dose) and Day 2, the vital signs measurement may be considered as a part of hypersensitivity monitoring and only either one will be recorded 
in the eCRF.  
12. The study drug will be administered on the subject’s lower abdomen except for the 5 cm around the subject’s navel.  
13. Samples for pharmacokinetic analysis will be obtained at the following time points: 
PK sampling time points 
Day 1 Pre-dose (within 60 minutes prior to administration of the study drug) 
Day 1 (6 hours after the administration of the study drug); ±15 minutes 
Day 1 (12 hours after the administration of the study drug); ±1 hour 
Day 2 (24 hours after the administration of the study drug); ±2 hours 

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Day 3, 4, 5, 5.5, 6, 6.5, 7, 8, and 9 (48, 72, 96, 108, 120, 132, 144, 168, and 192 hours, respectively, after the 
administration of the study drug); ±2 hours 
Day 15 and 22 (336 and 504 hours, respectively, after the administration of the study drug); ±4 hours  
Day 29, 43, 57, and 71 (i.e., EOS) after the administration of the study drug; ±1 day 
14. Sample for immunogenicity analysis on Day 1 will be performed prior to the study drug administration.    
15. For hypersensitivity monitoring, vital sign measurements will be performed before the start of the study drug administration (within 15 minutes) and at 3, 6, 12, and 24 hours 
after injection on Day 1. The tolerance window is ±30 minutes for 3 and 6 hours, and ±60 minutes for 12 and 24 hours after the administration. Either 3-lead or 12-lead ECG 
can be used for hypersensitivity monitoring at 3 hours (±30 minutes) after the administration of the study drug on Day 1 and additional ECG will be performed if a subject 
experiences cardiac symptoms. Emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support (inhalational therapy, oxygen and artificial 
ventilator) must be available. 
16. Injection site reaction will be assessed 30 minutes (±10 minutes) after the study drug administration. 
17. Local site pain will be observed using VAS immediately (within 15 minutes) after the study drug administration. 
18. Use of all prior and concomitant medications, from within 30 days prior to the administration of the study drug (Day 1) until the last assessment date or EOS visit, will be 
recorded. 
19. Adverse events (and serious adverse events) should be reported until the end of the subject’s participation in the study, regardless of the relationship to the study drug. 
 
 

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10.2 Appendix: VAS Subject’s Assessment of Pain 
Subject assessment of local site pain is measured by the subject indicating the extent of their pain 
by marking one line (│) through the 100 mm line (0 mm equals no pain and 100 mm equals most 
severe pain). The length of the line is measured from the left (in mm) and the value (in mm) 
recorded in the subject’s eCRF. 
 
No pain 
 
 
 
 
 
 
 
     Most severe pain 
 

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11 Reference List 
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Humira Product Monograph (PM). AbbVie Corporation, QC H4S 1Z1, Canada; March 2018. 
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Humira Summary of Product Characteristics (SmPC); AbbVie Limited, December 2018. 
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