A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection
Phase: PHASE1
Conditions: SARS-CoV-2 Infection
Sponsor: Celltrion

CLINICAL STUDY PROTOCOL 
A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel 
Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and 
Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute 
Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection 
PROTOCOL NUMBER CT-P59 1.2 
EudraCT Number: 
2020-003165-19 
Study Drug 
CT-P59 
Sponsor: 
CELLTRION, Inc. 
23, Academy-ro, Yeonsu-gu, Incheon 
22014, Republic of Korea 
Phone: +82 32 850 5000 
Fax: +82 32 850 5050 
Email: contact@celltrion.com 
Sponsor Contact : 
Sung Hyun Kim 
Head of Clinical Planning Department 
 
 
SAE Reporting : 
 
Version and Date of Protocol 
Protocol Version 1.3, 27 July 2020 
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 and the Declaration of 
Helsinki (World Medical Association 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. 

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Declaration of Investigator 
I have read and understood all sections of the protocol entitled ‘A Pilot Phase 1, Randomized, 
Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate 
the Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of SARS-CoV-
2 Infection’ and the accompanying current Investigator’s Brochure. 
I agree to supervise all aspects of the protocol and to conduct the clinical investigation in 
accordance with the Protocol Version 1.3, dated 27 July 2020, the International Council for 
Harmonisation harmonised tripartite guideline E6(R2): Good Clinical Practice, Declaration of 
Helsinki (World Medical Association 2013), and all applicable government regulations. I will 
not make changes to the protocol before consulting with CELLTRION, Inc. or implement 
protocol changes without Independent Ethics Committee (or Institutional Review Board) 
approval except to eliminate an immediate risk to patients. I agree to administer study drug only 
to patients under my personal supervision or the supervision of a Sub-Investigator. 
I will not supply the study drug to any person not authorized to receive it. Confidentiality will 
be protected. Patient 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: 
 
Address: 
 
 
 
Phone:  
 
 
 
 

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TABLE OF CONTENTS 
CLINICAL STUDY PROTOCOL ............................................................................................. 1 
Protocol Approval ....................................................................................................................... 2 
TABLE OF CONTENTS ............................................................................................................ 4 
LIST OF TABLES .................................................................................................................... 10 
LIST OF FIGURES .................................................................................................................. 10 
PROTOCOL SYNOPSIS ......................................................................................................... 11 
LIST OF ABBREVIATIONS ................................................................................................... 18 
1 
Introduction ....................................................................................................................... 20 
1.1 
Background ............................................................................................................... 20 
1.2 
CT-P59 ...................................................................................................................... 21 
1.2.1 
Nonclinical Studies ........................................................................................... 21 
1.2.2 
Clinical Studies ................................................................................................. 21 
1.3 
Study Rationale ......................................................................................................... 22 
1.3.1 
Rationale for Study Population ......................................................................... 22 
1.3.2 
Rationale for Dose Selection ............................................................................ 22 
1.4 
Benefit and Risk Assessment .................................................................................... 23 
2 
Study Objectives and Endpoints ....................................................................................... 25 
2.1 
Study Objectives ....................................................................................................... 25 
2.1.1 
Primary Objective ............................................................................................. 25 
2.1.2 
Secondary Objectives........................................................................................ 25 
2.2 
Study Endpoints ........................................................................................................ 25 
2.2.1 
Primary Endpoints ............................................................................................ 25 
2.2.2 
Secondary Endpoints ........................................................................................ 26 
2.2.2.1 Virology .................................................................................................... 26 
2.2.2.2 Efficacy ..................................................................................................... 26 
2.2.2.3 Pharmacokinetics ...................................................................................... 26 
2.2.2.4 Safety ........................................................................................................ 27 

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3 
Investigational Plan ........................................................................................................... 28 
3.1 
Study Design ............................................................................................................. 28 
3.2 
Rationale for Study Design ....................................................................................... 28 
3.3 
Dose Escalation and Stopping Criteria ..................................................................... 29 
3.3.1 
Dose Escalation Criteria ................................................................................... 29 
3.3.2 
Dose Stopping Rules ......................................................................................... 29 
3.4 
Study Overview ........................................................................................................ 30 
3.4.1 
Screening Period (Day -7 to Day 1) .................................................................. 30 
3.4.2 
Treatment Period (Day 1 to prior to End-of-Treatment Visit) .......................... 31 
3.4.3 
End-of-Treatment Visit (Day 90)...................................................................... 31 
3.4.4 
Follow-Up Period (From End-of-Treatment Visit to Day 180) ........................ 31 
4 
Patient Selection and Withdrawal Criteria ........................................................................ 32 
4.1 
Selection of Study Population ................................................................................... 32 
4.2 
Inclusion Criteria ...................................................................................................... 32 
4.3 
Exclusion Criteria ..................................................................................................... 34 
4.4 
Patient Withdrawal and Replacement ....................................................................... 37 
4.4.1 
Recruitment of Additional Patients ................................................................... 37 
4.5 
Premature Termination of the Clinical Trial ............................................................. 38 
5 
Study Treatment ................................................................................................................ 39 
5.1 
Method of Assigning Patients to Treatment Group .................................................. 39 
5.2 
Treatment Administered ........................................................................................... 39 
5.2.1 
CT-P59 .............................................................................................................. 39 
5.2.2 
Placebo .............................................................................................................. 40 
5.2.3 
Dose Modification ............................................................................................ 40 
5.3 
Management of Clinical Supplies ............................................................................. 40 
5.3.1 
Study Drug Packaging, Labeling, and Storage ................................................. 40 
5.3.2 
Study Drug Accountability ............................................................................... 41 
5.4 
Blinding..................................................................................................................... 42 

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5.5 
Breaking the Blind .................................................................................................... 42 
5.6 
Treatment Compliance .............................................................................................. 43 
5.7 
Prior, Concomitant, and Prohibited Medications ...................................................... 43 
5.8 
Restriction ................................................................................................................. 43 
5.8.1 
Dietary and Fluid Restrictions .......................................................................... 43 
5.8.2 
Other Restrictions ............................................................................................. 44 
6 
Study Assessments and Procedures .................................................................................. 47 
6.1 
Safety Assessments ................................................................................................... 47 
6.1.1 
Adverse Events ................................................................................................. 47 
6.1.1.1 Definition of Adverse Events .................................................................... 47 
6.1.1.1.1 Serious Adverse Events..................................................................... 48 
6.1.1.1.2 Unlisted (Unexpected) Serious Adverse Events ............................... 49 
6.1.1.1.3 Suspected Unexpected Serious Adverse Reactions .......................... 49 
6.1.1.1.4 Adverse Events of Special Interest ................................................... 50 
6.1.1.1.5 Eliciting and Documenting Adverse Events ..................................... 50 
6.1.1.1.6 Reporting Adverse Events................................................................. 50 
6.1.1.1.7 Reporting Serious Adverse Events .................................................... 51 
6.1.1.1.8 Follow-up of Adverse Events............................................................ 52 
6.1.1.2 Assessment of Severity ............................................................................. 52 
6.1.1.3 Assessment of Causality ........................................................................... 52 
6.1.2 
Medical History and Demographic Information ............................................... 53 
6.1.3 
Viral Serology Test ........................................................................................... 53 
6.1.4 
Urine Drug Test ................................................................................................ 54 
6.1.5 
Hypersensitivity Monitoring ............................................................................. 54 
6.1.6 
Vital Signs, Weight, and Height ....................................................................... 54 
6.1.7 
Electrocardiogram ............................................................................................. 55 
6.1.8 
Physical Examination........................................................................................ 55 
6.1.9 
Pregnancy .......................................................................................................... 55 

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6.1.10 Radiography ...................................................................................................... 56 
6.1.11 Clinical Laboratory Analyses ........................................................................... 56 
6.1.12 Immunogenicity Assessments ........................................................................... 57 
6.1.13 SARS-CoV-2 Infection Related Signs and Symptoms ..................................... 57 
6.1.14 Potential Effects on the Incidence of Antibody-dependent Enhancement ........ 57 
6.2 
Virology Assessments ............................................................................................... 58 
6.3 
Efficacy Assessments................................................................................................ 59 
6.3.1 
Patient Diary for SARS-CoV-2 Infection Symptom Checklist ........................ 59 
6.3.2 
Disease Status Monitoring ................................................................................ 60 
6.3.2.1 Requirement of supplemental oxygen ...................................................... 61 
6.3.2.2 Intensive care unit transfer ........................................................................ 61 
6.3.2.3 Mechanical ventilation use ....................................................................... 61 
6.3.2.4 Hospitalization .......................................................................................... 61 
6.4 
Pharmacokinetic Assessments .................................................................................. 61 
6.5 
Sample Collection ..................................................................................................... 62 
6.5.1 
Pharmacokinetic Blood Sampling..................................................................... 62 
6.5.2 
Immunogenicity Blood Sampling ..................................................................... 62 
6.5.3 
Safety Blood Sampling ..................................................................................... 62 
6.5.4 
Safety Urine Sampling ...................................................................................... 63 
6.5.5 
Virology Sampling ............................................................................................ 63 
6.6 
Labeling, Storage, and Transportation of Samples ................................................... 63 
6.6.1 
Sample Labeling ............................................................................................... 63 
6.6.2 
Sample Storage and Shipment .......................................................................... 63 
7 
Statistical Analysis ............................................................................................................ 64 
7.1 
Sample Size Calculation ........................................................................................... 64 
7.2 
Analysis Sets ............................................................................................................. 64 
7.3 
Description of Subgroups to be analyzed ................................................................. 64 
7.4 
Statistical Analysis Methodology ............................................................................. 65 

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7.4.1 
General Consideration ...................................................................................... 65 
7.4.2 
Study Population ............................................................................................... 65 
7.4.2.1 Disposition of Patients .............................................................................. 65 
7.4.3 
Safety Analysis ................................................................................................. 65 
7.4.3.1 Demographic, Baseline, and Background Characteristics ........................ 65 
7.4.3.2 Adverse Events ......................................................................................... 65 
7.4.3.3 Clinical Laboratory and Pregnancy Test ................................................... 66 
7.4.3.4 Electrocardiogram, Physical Examination, and Vital Signs ..................... 66 
7.4.3.5 Prior and Concomitant Medications ......................................................... 67 
7.4.3.6 Immunogenicity ........................................................................................ 67 
7.4.3.7 SARS-CoV-2 Infection Related Signs and Symptoms ............................. 67 
7.4.3.8 Potential Effects on the Incidence of Antibody-dependent Enhancement 67 
7.4.4 
Virology Analysis ............................................................................................. 67 
7.4.5 
Efficacy Analysis .............................................................................................. 67 
7.4.6 
Pharmacokinetic Analysis ................................................................................. 68 
7.5 
Interim Analysis ........................................................................................................ 68 
7.6 
Data Quality Assurance ............................................................................................ 68 
8 
Investigator’s Obligations ................................................................................................. 70 
8.1 
Confidentiality .......................................................................................................... 70 
8.2 
Independent Ethics Committee ................................................................................. 70 
8.3 
Patient Information and Consent .............................................................................. 71 
8.4 
Study Reporting Requirements ................................................................................. 72 
8.5 
Financial Disclosure and Obligations ....................................................................... 72 
8.6 
Investigator Documentation ...................................................................................... 73 
8.7 
Study Conduct ........................................................................................................... 74 
8.8 
Data Collection ......................................................................................................... 74 
8.8.1 
Electronic Case Report Forms and Source Documents .................................... 74 
8.9 
Adherence to Protocol............................................................................................... 74 

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8.10 Investigator’s Final Report ....................................................................................... 74 
8.11 Record Retention ...................................................................................................... 75 
8.12 Patient Identification Register................................................................................... 75 
8.13 Publications ............................................................................................................... 75 
9 
Study Management ........................................................................................................... 76 
9.1 
Sponsor ..................................................................................................................... 76 
9.2 
Vendor Contact ......................................................................................................... 76 
9.3 
Central Analytical Facility ........................................................................................ 76 
9.4 
Monitoring ................................................................................................................ 77 
9.4.1 
Dose Escalation Committee .............................................................................. 77 
9.4.2 
Data and Safety Monitoring Board ................................................................... 77 
9.4.3 
Monitoring of the Study .................................................................................... 77 
9.4.4 
Inspection of Records ....................................................................................... 78 
9.5 
Management of Protocol Amendments and Deviations ........................................... 78 
9.5.1 
Modification of the Protocol ............................................................................. 78 
9.5.2 
Protocol Deviations ........................................................................................... 78 
9.6 
Study Termination .................................................................................................... 79 
9.7 
Final Report .............................................................................................................. 79 
10 Reference List ................................................................................................................... 80 
11 Appendices ........................................................................................................................ 81 
11.1 Schedule of Assessments .......................................................................................... 81 
11.2 SARS-CoV-2 Infection SYMPTOM CHECKLIST ................................................. 86 
 
 
 

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LIST OF TABLES 
Table 6-1 Schedule of Assessments for Hypersensitivity Monitoring ................................. 54 
Table 6-2 Nasopharyngeal Swap Sampling Time Points for Virology Assessment ............ 59 
Table 6-3 Blood Sampling Time Points for Pharmacokinetic Assessment .......................... 61 
Table 11-1 Schedule of Assessments .................................................................................... 81 
Table 11-2 Schedule of Assessments for Patients with Suspicious ADE Occurrence 
(Unscheduled Visits) ..................................................................................................... 85 
 
LIST OF FIGURES 
Figure 3-1 Study Overview ................................................................................................... 23 
 
 

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PROTOCOL SYNOPSIS 
Protocol Number: CT-P59 1.2 
Title: A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose 
Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe 
Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection 
Study Phase: Phase 1 
Sponsor: CELLTRION, Inc. 
Study Center: Approximately 5 centers in Republic of Korea, Romania and United Kingdom 
Test Drug Formulation, Dose, and Regimen: 
CT-P59 (960 mg/16 mL): 20 mg/kg, 40 mg/kg or 80 mg/kg, intravenous (IV) infusion for 90 minutes (± 15 
minutes) 
Reference Drug Formulation, Dose, and Regimen: 
Placebo (16 mL): matching in volume to each dose of CT-P59, IV infusion for 90 minutes (± 15 minutes) 
Objectives: 
Primary objective 
 
To evaluate the preliminary safety and tolerability of CT-P59 up to Day 14 of the last enrolled patient 
Secondary objectives 
 
To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates 
 
To evaluate the efficacy of CT-P59 
 
To evaluate the PK of CT-P59 
 
To evaluate additional safety of CT-P59 including immunogenicity 
Main Selection Criteria: 
Adult male or female patients aged 18 to 60 years (both inclusive), with mild symptoms of SARS-CoV-2 
infection diagnosed by reverse transcription polymerase chain reaction (RT-PCR) and no more than 7 days 
prior to the study drug administration from the onset of symptom will be considered for enrollment in the study 
if they meet all of the inclusion criteria and none of the exclusion criteria. 
Inclusion Criteria: 
Each patient must meet all of the following criteria to be randomized in this study: 
1. 
Adult male or female patient, aged between 18 to 60 years (both inclusive). 
2. 
Patient with laboratory confirmed SARS-CoV-2 infection by RT-PCR at Screening. 
Note: But, if the patient had RT-PCR result confirming SARS-CoV-2 infection prior to obtaining written 
informed consent (but no more than 7 days from the onset of symptoms), the result can be allowed. 
Note: During the Screening Period, only one retest for RT-PCR will be allowed, if study drug can be 
administered no more than 7 days from onset of symptom based on the retest results. 
3. 
Patient has mild conditions meeting all of the following criteria: 
a. Oxygen saturation ≥ 94% on room air. 
b. Not requiring supplemental oxygen. 
4. 
Patient has one or more of the following SARS-CoV-2 infection associated symptoms within 7 days prior 
to the study drug administration: 
a. Feeling feverish 
b. Cough 
c. Shortness of breath or difficulty breathing 
d. Sore throat 
e. Body pain or muscle pain 
f. Fatigue 
g. Headache 
h. Chills 
i. Nasal obstruction or congestion 
j. Loss of taste or smell 
k. Nausea or vomiting 
l. Diarrhea 
5. 
Patient has one or more of the following SARS-CoV-2 infection associated symptoms present within 48 
hours prior to the study drug administration: 

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a. Feeling feverish 
b. Cough 
c. Shortness of breath or difficulty breathing 
d. Sore throat 
e. Body pain or muscle pain 
f. Fatigue 
g. Headache 
6. 
Onset of symptom is no more than 7 days prior to the study drug administration. Onset time of symptom 
is defined as the time when the patient experienced the presence of at least one symptom of the SARS-
CoV-2 infection. 
7. 
Patient with a body weight between 50 kg and 100 kg (both inclusive) and a body mass index of ≥ 18.0 
kg/m2. 
8. 
Patient is able to understand and to comply with protocol requirements, instructions, and restrictions. 
9. 
Patient voluntarily agrees to participate in this study and has given a written informed consent prior to 
undergoing any of the Screening procedures. 
10. Patients and their partners of childbearing potential must agree to use a highly effective method of 
contraception or two acceptable methods of contraception until 6 months after the study drug 
administration as specified in Section 5.8.2. A woman is considered of childbearing following menarche 
and until becoming post-menopausal unless permanently sterile. A menopausal female must have no 
menses more than 12 months without an alternative medical cause prior to the date of informed consent 
to be classified as not of childbearing potential. A man is considered fertile after puberty unless 
permanently sterile by bilateral orchidectomy. Patients and their partners who have been surgically 
sterilized for less than 6 months prior to the date of informed consent must agree to use any medically 
acceptable methods of contraception. 
Exclusion Criteria: 
A Patient meeting any of the following criteria will be excluded from the study: 
1. 
Patient with severe condition meeting one of the following: 
a. Respiratory distress with respiratory rate ≥ 30 breaths/min. 
b. Requires supplemental oxygen. 
c. Experience shock. 
d. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by 
Investigator’s discretion. 
e. Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of 
the Investigator, including but not limited to radiographic findings in lung. 
2. 
Patient has a medical history or current presence of disease including one or more of the following(s): 
a. Clinical hematology results of neutrophil count < 1.0×103 cells/µL (International System of Units < 
1.0×109 cells/L) at Screening and Day 1. 
b. Clinically significant condition of allergic reaction (e.g., urticaria, angio-oedema), atopic condition 
(asthma and eczematous dermatitis) in the Investigator’s opinion and/or hypersensitivity including 
known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any 
components of study drugs. 
c. History of and/or current medical condition, classed as clinically significant by the Investigator, 
including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological, metabolic 
(including known diabetes mellitus), cardiovascular, or psychiatric condition. 
d. History or any concomitant active malignancy. 
e. History of and/or current infection with human immunodeficiency virus, hepatitis B or hepatitis C. 
f. History of serious infection (associated with hospitalization and/or which required intravenous 
antibiotics) within 6 months before the study drug administration and/or current infection, other than 
SARS-CoV-2 infection, requiring a course of systemic anti-infective therapy. 
g. History of an illness, other than SARS-CoV-2 infection, within 28 days prior to the study drug 
administration that is identified as clinically significant by the Investigator and/or requires 
hospitalization. 
h. History of surgical intervention and/or an operation within 28 days prior to the study drug 
administration or plans to have a surgical procedure during the study period. 

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3. 
Patient had a history of or concurrent use of medications including any prior therapy of following(s): 
a. Any vaccinations within 4 weeks prior to the study drug administration. 
b. Blood transfusion, or participated in another clinical trial within 3 months prior to the study drug 
administration. 
c. Treatment with any monoclonal antibody, fusion protein, or biologics within 6 months prior to the 
study drug administration. 
d. Any off-label or other investigational drugs prescribed for the treatment of SARS-CoV-2 infection. 
e. Potential antiviral drugs and/or immune-based therapy under evaluation for treatment of SARS-CoV-
2 infection. 
f. Use of medications that are contraindicated with standard of care (SoC). 
4. 
A male patient plans to father a child or donate sperm or a female patient is lactating or planning to be 
pregnant or to breastfeed within 6 months from the study drug administration. 
5. 
Patient shows reasonable evidence of drug/alcohol/nicotine abuse prior to the study drug administration 
as opinion of the Investigator or has following(s): 
a. Positive result for drug urine test during Screening and/or the opinion of the Investigator. 
b. History or presence of regular consumption exceeding an average weekly intake of > 14 units of alcohol 
in recent 3 months prior to the study drug administration. 
c. Consuming more than 10 cigarettes or equivalent per day within a month prior to the study drug 
administration. 
6. 
Patient is unwilling to avoid the use of alcohol or alcohol containing foods, medications, or beverage 
within 48 hours prior to admission and 24 hours prior to each study visit throughout the study or unable 
to refrain from smoking during the in-house stays. 
7. 
Patient donated or lost 400 mL or more whole blood within 8 weeks (plasma/platelets donation within 4 
weeks) prior to the study drug administration. 
8. 
Patient shows evidence of a condition (psychological, emotional problems, any disorders or resultant 
therapy) that is likely to invalidate health information, consent, or limit the ability of the patient to comply 
with the protocol requirements in the opinion of the Investigator. 
9. 
Patient is vulnerable (e.g., employees of the clinical trial site 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). 
10. Patient is not likely to complete the study for whatever reason other than criteria listed above in the opinion 
of the Investigator. 
Study Design: 
This is a randomized, double-blind, placebo-controlled, parallel group, single ascending dose, Phase 1, pilot 
study to evaluate the safety, tolerability and virology of CT-P59 in combination with SoC, except potential 
antiviral drugs and/or immune-based therapy under evaluation for treatment of SARS-CoV-2 infection, in 
patients with mild symptoms of SARS-CoV-2 infection. 
Approximately 18 patients in 3 cohorts are planned for enrollment and each cohort will consist of 6 patients, 5 
of whom will receive CT-P59 and 1 of whom will receive a placebo. In each cohort, patients will be randomized 
in a 5:1 ratio to receive CT-P59 or placebo. 
This study will be started with the lowest dose that will maximize safety and the dose levels will be escalated 
to the higher doses. The overview of the study is presented in Figure 1. 

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Figure 1. Study Design Overview 
 
After each study drug administration, patients will be observed for 48 hours for evaluation of the safety and 
tolerability of the study drug. 
When escalating dose from previous cohort to next cohort, Dose Escalation Committee (DEC) will review all 
available safety data of all patients in each cohort, within an observation period of 48 hours after study drug 
administration. If no safety or tolerability concern is observed, patients in next cohort will receive study drug. 
The dose escalation from a previous cohort to the next cohort will be stopped if one or more of the following 
stopping criteria are met: 
 
Two or more patients in one cohort experience TEAEs of grade 3 or higher, which are considered to be 
related to study drug. 
 
Four or more patients in one cohort experience TEAEs of grade 2 or higher, which are considered to be 
related to study drug. 
 
One or more patients in one cohort experience a treatment-emergent serious AE (TESAE), which are 
considered to be related to study drug. 
If an event corresponding to the above criteria occurs within the observation period of 48 hours in each cohort 
and the dosing is temporarily stopped under the decision of DEC, the appointed independent Data and Safety 
Monitoring Board (DSMB) members will evaluate the relationship to CT-P59 of the event with unblinded 
manner and make a decision on continuation and the dose escalation of the study. 
If an event corresponding to the above criteria occurs after observation period of 48 hours in the previous 
cohort, further progression to next cohort will be temporarily stopped and the appointed independent DSMB 
members will review data and make a decision on continuation and the dose escalation of the study. 
If it was revealed that an event corresponding to the above criteria occurs and all the TEAEs are related to CT-
P59 as reviewed by DSMB members, the study will be temporarily stopped and the information will be 
submitted to regulatory authority for further evaluation and confirmation on continuation of the dose escalation 
of the study. 
Study Procedure: 
The total duration of this study will be approximately 27 weeks for the individual patient, including Screening 
Period and Follow-Up Period. 
Screening (Day -7 to Day 1) 
Patients will sign and date the informed consent form and undergo procedures to determine eligibility. 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 patient will be screen failed. Only 
one retest for RT-PCR will be allowed, if study drug can be administered no more than 7 days from onset of 
symptom based on retest results. And, if there is available RT-PCR result confirming SARS-CoV-2 infection 
prior to obtaining written informed consent (but no more than 7 days from the onset of symptoms), the result 
can be allowed.  
If Screening visit date and the administration of study drug date (Day 1) are same, all assessments scheduled 
for the Screening and Day 1 visit can be performed only once on the date before randomization 
Treatment Period (Day 1 to prior to End-of-Treatment Visit) 

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Inclusion and exclusion criteria will be re-confirmed on Day 1. If it is concluded that the patients are not eligible 
in Day 1 assessments, the patient will be considered as Screening failure even if he/she was eligible based on 
assessments results performed during Screening Period. 
Patients will be randomized in 5:1 ratio to receive CT-P59 or placebo once all eligibility criteria have been 
confirmed. Patients will receive a single dose of CT-P59 or placebo on Day 1. 
All patients will be admitted to the study center on Day 1 and it is recommended to be confined up to Day 7. 
In-house stay period can be determined by Investigator considering the isolation regulation and/or public health 
capacity of the country, however all patients should be confined to the study center for at least 72 hours (until 
completion of all assessments on Day 3). 
After discharge, the consecutive study visits will be carried out on an out-patient basis. During the isolation 
period according to the local regulation, patients will visit the study center using the transportation provided 
by Sponsor. 
End-of-Treatment Visit (Day 90) 
End-of-treatment (EOT) visit assessments will be performed on Day 90. If a patient early terminated from the 
study, the patient will be asked to return to the study center as soon as possible for the safety assessments 
predefined for EOT visit. 
Follow-Up Period (From End-of-Treatment Visit to Day 180) 
For all patients including a patient who early terminated from the study, each telephone call follow-up will 
occur bi-weekly from 2 weeks after the EOT visit to Day 180. During the Follow-Up Period, SARS-CoV-2 
infection related signs and symptoms will be assessed by telephone call to capture the suspicious antibody 
dependent enhancement (ADE) occurrence. For patients with suspicious ADE occurrence, additional 
assessments will be conducted on unscheduled visit. 
Study Endpoint: 
Primary endpoints 
Primary endpoints will be analyzed based on the data up to Day 14 of the last enrolled patient. 
Safety 
 
Treatment-emergent adverse events (TEAEs) 
 
Treatment-emergent serious AEs (TESAEs) 
 
Treatment-emergent AEs of special interest (TEAESI; infusion related reactions including 
hypersensitivity/anaphylactic reaction) 
 
Potential effects on the incidence of ADE 
 
Vital signs (blood pressure, heart rate, body temperature, SpO2 and respiratory rate) 
 
Hypersensitivity monitoring 
 
Twelve-lead electrocardiogram (ECG) 
 
Severe Acute Respiratory Syndrome Coronavirus infection related signs and symptoms 
 
Radiography (chest x-ray and/or chest CT) 
 
Clinical laboratory tests (clinical chemistry, hematology, and urinalysis) 
Secondary endpoints 
Secondary virology, efficacy, PK, and safety endpoints will be analyzed. 
Virology 
 
Viral shedding in nasopharyngeal swab specimens based on quantitative polymerase chain reaction 
(qPCR) and cell culture 
 
Genotyping of SARS-CoV-2 viral isolates 
Efficacy 
 
Time to clinical recovery up to Day 28 
 
Proportion of patients with clinical recovery up to Day 7, 14, 28 
 
Proportion of patients requiring supplemental oxygen up to Day 7, 14, 28 
 
Proportion of patients with intensive care unit transfer up to Day 7, 14, 28 
 
Proportion of mechanical ventilation up to Day 7, 14, 28 
 
Proportion of patients with all-cause mortality up to Day 14, 28 
 
Proportion of patients with hospital admission up to Day 14, 28 
Pharmacokinetics 
 
Area under the concentration-time curve from time zero to infinity (AUC0-inf) 

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 
Dose normalized AUC0-inf (AUC0-inf/Dose) 
 
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) 
 
Dose normalized AUC0-last (AUC0-last/Dose) 
 
Maximum serum concentration (Cmax) 
 
Dose normalized Cmax (Cmax/Dose) 
 
Time to Cmax (Tmax) 
 
Terminal half-life (t1/2) 
 
Percentage of AUC0-inf obtained by extrapolation (%AUCext) 
 
Terminal elimination rate constant (λz) 
 
Total body clearance (CL) 
 
Volume of distribution during the elimination phase (Vz) 
Safety 
 
Treatment-emergent adverse events (TEAEs) 
 
Treatment-emergent serious AEs (TESAEs) 
 
Treatment-emergent AEs of special interest (TEAESI; infusion related reactions including 
hypersensitivity/anaphylactic reaction) 
 
Potential effects on the incidence of ADE 
 
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) 
 
Vital signs (blood pressure, heart rate, body temperature, SpO2 and respiratory rate) 
 
Hypersensitivity monitoring 
 
Twelve-lead electrocardiogram (ECG) 
 
Severe Acute Respiratory Syndrome Coronavirus infection related signs and symptoms 
 
Radiography (chest x-ray and/or chest CT) 
 
Clinical laboratory test (clinical chemistry, hematology, and urinalysis) 
 
Physical examinations 
Sample Size: 
The total sample size of 18 patients is not based on a formal statistical hypothesis. A sample size justification 
based on statistical hypotheses is not relevant in this study. The proposed number of 6 patients (5 patients for 
CT-P59 and 1 patient for placebo) in each cohort is set empirically based on sample sizes in other Phase 1 
studies investigating the safety and tolerability of their study drugs and is considered to be sufficient to achieve 
the objectives of the study. 
Statistical Methods: 
Statistical Analysis 
The statistical analysis will be performed using Statistical Analysis System Software Version 9.4 or higher 
(SAS institute Inc., Cary, North Carolina, US). The statistical methods for this study will be described in a 
detailed statistical analysis plan (SAP). 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 clinical study reports. 
Analysis Sets 
Intent-to-treat (ITT) Set: The ITT Set is defined as all randomly assigned patients to study drug. 
Safety Set: The Safety Set will include all randomized patients who received a full or partial dose of the study 
drug. 
Pharmacokinetic Set: The PK Set will include all patients in the Safety Set who received a full dose of CT-P59 
and provide at least 1 evaluable post-treatment PK concentration result. 
Safety analysis 
Safety analyses will be performed in the Safety Set, unless otherwise indicated. Adverse events will be recorded 
according to the Common Terminology Criteria for Adverse Events Version 5.0 and will be coded to system 
organ class and preferred term according to Medical Dictionary for Regulatory Activities. The AE summaries 
will be reported by system organ class, preferred term, and the cohort of CT-P59 groups and pooling of placebo 
group, as appropriate. If more than 1 AE is recorded for a patient within any system organ class or preferred 
term, the patient will be counted only once within the respective summary. Adverse events will also be 
summarized by maximum intensity and relationship to study drug with the percentage of patients in each 
category. All AE data will be presented in the data listings, and additional TEAE analyses may be performed 

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as detailed in the SAP. Prior and concomitant medications will be coded using the World Health Organization 
Drug Dictionary. Safety data on results of clinical laboratory test, ECG, physical examinations, vital signs, 
prior and concomitant medications, immunogenicity, SARS-CoV-2 infection related signs and symptoms, 
potential effects on the incidence of ADE, hypersensitivity monitoring, radiography, and pregnancy tests will 
be listed and summarized by visits as well as by the cohort of CT-P59 groups and pooling of placebo group. 
Virology analysis 
Characterization of SARS-CoV-2 viral isolate (viral shedding based on qPCR and cell culture and genotype) 
will be analyzed on the ITT set. Actual values and change from baseline for viral shedding, percentage of 
patients with positive/negative viral shedding, duration (in days) of viral shedding, and AUC of viral levels 
will be summarized by the cohort of CT-P59 groups and pooling of placebo group at each scheduled visit using 
descriptive statistics or frequency tables. Mean viral load titer (log values) for each scheduled time point will 
be plotted. Genotype results will be presented in data listing by the cohort of CT-P59 groups and pooling of 
placebo group. 
Efficacy analysis 
The secondary efficacy endpoints will be analyzed on ITT set and will be summarized by the cohort of CT-
P59 groups and pooling of placebo group using descriptive statistics or frequency tables. 
Pharmacokinetic analysis 
All PK analyses will be conducted in the PK set. The PK parameters of CT-P59 will be analyzed using 
noncompartmental methods based on the actual sampling time points. All parameters will be calculated using 
Phoenix WinNonlin (Pharsight, St Louis, Missouri, US). Pharmacokinetic parameters and PK concentration 
data will be presented in listings and summarized in tables by cohort of CT-P59 groups. The tables will display 
the following descriptive statistics: the number of observations (n), mean, standard deviation (SD), median, 
minimum, maximum, geometric mean and coefficient of variation. 

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LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
%AUCext 
Percentage of AUC0-inf obtained by extrapolation  
ABV 
alcohol by volume 
ACE2 
angiotensin-converting enzyme 2 
ADA 
anti-drug antibody 
ADE 
antibody-dependent enhancement 
ADL 
activities of daily living  
AE 
adverse event 
AESI 
adverse events of special interest  
ALT 
alanine transaminase 
AST 
aspartate transaminase 
AUC 
area under the concentration-time curve  
AUC0-inf 
area under the concentration-time curve from time zero to infinity  
AUC0-last 
area under the concentration-time curve from time zero to the last quantifiable 
concentration  
AUC0-24hr 
area under the concentration-time curve over a 24 hour dosing interval 
AUC0-48hr 
area under the concentration-time curve over a 48 hour dosing interval 
AUC0-72hr 
area under the concentration-time curve over a 72 hour dosing interval 
BMI 
body mass index  
CL 
total body clearance  
Cmax 
maximum serum concentration  
COVID-19  
corona virus disease 19 
CRO 
contract research organization  
CSR 
clinical study report 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Event 
DEC 
Dose Escalation Committee  
DSMB 
Data and Safety Monitoring Board 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
Electronic Data Capture  
EOT 
end-of-treatment  
ESR 
erythrocyte sedimentation rate  
GCP 
Good Clinical Practice  
HBcAb 
hepatitis B core antibody 
HBsAg 
hepatitis B surface antigen 
HIV 
human immunodeficiency virus 
IB 
Investigator’s brochure  
ICF  
informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
ITT 
Intent-to-treat  
IV 
intravenous  
IVRS 
interactive voice response system 
IWRS 
interactive web response system 
NAb 
neutralizing antibody 
OTC 
over-the-counter 
PK 
pharmacokinetic 
qPCR 
quantitative polymerase chain reaction 
RBD 
receptor binding protein 
RT-PCR 
reverse transcription polymerase chain reaction 
SAE 
serious adverse event 

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SAP 
statistical analysis plan 
SARS‑CoV‑2 
severe acute respiratory syndrome coronavirus 2 
SD 
standard deviation 
SoC 
standard of care 
SOP 
standard operating procedure 
SpO2 
peripheral capillary oxygen saturation 
t1/2 
Terminal half-life  
TEAE 
Treatment-emergent adverse event 
TEAESI 
Treatment-emergent adverse events of special interest 
TESAE 
Treatment-emergent serious adverse event 
Tmax 
Time to Cmax 
Vz 
Volume of distribution during the elimination phase 
WHO 
World Health Organization 
λz 
Terminal elimination rate constant 

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1 Introduction 
1.1 Background 
Coronaviruses are single stranded ribonucleic acid viruses, capable of causing life threatening 
disease in humans and animals. The novel severe acute respiratory syndrome coronavirus 2 
(SARS-CoV-2) was initially identified during an outbreak of atypical viral pneumonia cases of 
unknown cause in the People’s Republic of China (hereafter “China”) in December 2019. Most 
of the initial infections outside of China were travel associated (i.e., from people who had 
travelled from the infected regions of China to other countries), although person to person 
transmission in other countries was quickly established. The disease caused by SARS-CoV-2 
has been designated as coronavirus disease 2019, known as COVID-19 (World Health 
Organization [WHO] disease outbreak news, 2020). 
Most people with SARS-CoV-2 infection develop only mild (40%) or moderate (40%) disease. 
However, approximately 15% develop severe disease that requires oxygen support, and 5% 
have critical disease with complications such as respiratory failure, acute respiratory distress 
syndrome, sepsis and septic shock, thromboembolism, and/or multiorgan failure, including 
acute kidney injury and cardiac injury. Older age, smoking and underlying noncommunicable 
diseases, such as diabetes, hypertension, cardiac disease, chronic lung disease, and cancer have 
been reported as risk factors for severe disease and death. 
Severe acute respiratory syndrome coronavirus 2 infection is also associated with mental and 
neurological manifestations, including delirium or encephalopathy, agitation, ischemic and 
hemorrhagic stroke, meningoencephalitis, impaired sense of smell or taste, anxiety, depression, 
and sleep problems. In many cases, neurological manifestations have been reported even 
without 
respiratory 
symptoms. 
Case 
reports 
of 
Guillain-Barré 
syndrome 
and 
meningoencephalitis among people with SARS-CoV-2 infection have also been reported. 
Clinical manifestations of SARS-CoV-2 infection are generally milder in children compared 
with adults. Relatively few cases of infants confirmed with SARS-CoV-2 infection have been 
reported. However, most recently a multisystem inflammatory syndrome temporally associated 
with SARS-CoV-2 infection in children and adolescents has been described (WHO Guidelines, 
2020). 
Coronavirus entry into host cells is an important determinant of viral infectivity and 
pathogenesis. It is also a major target for host immune surveillance and human intervention 
strategies. It has been established that SARS-CoV-2 binds via the angiotensin-converting 
enzyme 2 (ACE2) receptor located on epithelial and endothelial cells which traverse multiple 

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organs (Varga et al., 2020). SARS-CoV-2 infection is initiated by binding of the SARS-CoV-2 
spike protein to ACE2 via the receptor binding protein (RBD) of the spike protein, which 
mediates viral entry into the target cells. The virus is mutating, indicating that virulence and 
transmission will shift over time, and showing diversity in this critical surface protein. New 
evidence suggests there are 2 strains of SARS-CoV-2; L-type and S-type (Tang et al., 2020). 
S-type is the less aggressive (30%); the L-type is now the most prevalent strain (70%) and is 
more aggressive. Additionally, individuals appear to be affected to different degrees with 
varying symptoms and outcomes. These findings strongly support an urgent need for immediate 
comprehensive studies and robust validation of testing methods that combine genomic data, 
chart records and clinical symptoms, to help better understand the disease, enable risk 
assessment, triage and support public health resource planning. 
1.2 CT-P59 
CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for 
SARS-CoV-2 infection. The dosage form of CT-P59 is solution concentrate for dilution for 
administration in a single intravenous (IV) infusion. 
The main mechanism of action is binding to SARS-CoV-2 RBD and the cellular receptor, ACE2, 
thus blocking the SARS-CoV-2 infection. Although it is known that in many virus infections 
antibodies can remove the virus-infected cells via antibody Fc-dependent function such as 
antibody dependent cellular cytotoxicity, it’s unlikely that CT-P59 induces antibody 
Fc-dependent virus clearance, considering the life cycle of SARS-CoV-2 which is assembled 
inside cells and released via exocytosis. However, it is postulated that there are additional 
mechanisms of CT-P59 mediated virus clearance by opsonization and complement activation 
(i.e., antibody dependent, complement-dependent virolysis or antibody dependent 
phagocytosis). 
1.2.1 Nonclinical Studies 
The nonclinical program for CT-P59 has been designed to support clinical studies. Detailed 
information regarding the nonclinical pharmacology and toxicology of CT-P59 can be found in 
the Investigator’s brochure (IB). 
1.2.2 Clinical Studies 
CT-P59 has not been administered in humans yet. 

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1.3 Study Rationale 
There are currently no approved monoclonal antibody therapies available to treat coronaviruses 
such as SARS-CoV-2 and there is an urgent public health need for the rapid development of 
such interventions. On 11 March 2020, the WHO declared the SARS-CoV-2 infection outbreak 
a global pandemic as there were more than 118,000 cases in 114 countries, and 4,291 people 
had lost their lives. According to the WHO coronavirus disease situation report-135, about 6.28 
million people were confirmed to have SARS-CoV-2 infection in 216 countries and fatalities 
exceeded about 380,000. 
CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 
infection. The anticipated high affinity and targeted effect of CT-P59 is expected to enable 
antiviral activity. In this study, safety, tolerability, and virology of CT-P59 will be evaluated in 
patients with mild symptoms of SARS-CoV-2 infection. 
1.3.1 Rationale for Study Population 
The study population depend on the clinical data and recommendation from the regulatory 
authority and CELLTRION’s development program is focusing on evaluating safety and 
tolerability in patients with mild symptoms of SARS-CoV-2 infection. The expected patient 
population is adults only. 
1.3.2 Rationale for Dose Selection 
In this study, there will be three dose levels and an approximate 2-fold increase between doses. 
The planned starting dose is 20 mg/kg and the proposed top dose is 80 mg/kg. 
The pharmacokinetic (PK) profile of CT-P59 is expected to be similar to those of CT-P27, an 
anti-influenza antibody drug to treat influenza under development by the Sponsor. CT-P27 drug 
product is a combination of the two human immunoglobulin G1 monoclonal antibodies. This is 
due to the structural similarity between the CT-P27 monoclonal antibodies and the CT-P59 
monoclonal antibody, in that CT-P59 shares an identical human immunoglobulin G1 Fc region 
backbone with the two monoclonal antibodies of CT-P27. 
Doses of CT-P27 in the range of 7.5 to 30 mg/kg were shown to exhibit increasing efficacy in 
virus-challenged mice and ferrets and are also within the range of doses for other approved 
human monoclonal antibodies for IV infusion.  
The efficacious dose of CT-P59 in ferrets was determined as 30 mg/kg based on viral load and 
pathology. The nonhuman primate efficacious doses estimated as partial areas under the 
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partial AUCs at 30 mg/kg were about 12-18 mg/kg. Taking the assumption of no PK difference 
(partial AUCs) between human and nonhuman primates as well as the similar PK assumed 
between CT-P27 and CT-P59 into account, 20 mg/kg of CT-P59 will be likely to be efficacious 
in patients as well. Thus, the starting dose of 20 mg/kg of CT-P59 was selected as an effective 
dose for clinical trials of CT-P59. 
In the 2-week repeat dose nonhuman primate toxicity study of CT-P27, the no-observable-
adverse effect-level was 320 mg/kg. Applying a safety factor of 10, it was expected that a dose 
of up to 32 mg/kg could be supported as posing a very low risk of inducing adverse effects in 
human. In clinical trials, doses up to 90 mg/kg of CT-P27 were well tolerated. As 400 mg/kg of 
top dose is selected for 2-week repeat dose toxicology of CT-P59, greater safety factor over that 
of CT-P27 is expected to support the clinical trials.  
The half-lives of the components of CT-P22 and CT-P23, comprising CT-P27, are 
approximately 17 days and 18 days, respectively. Assuming that the PK of CT-P59 and CT-P27 
will be similar, due to the structural similarity between the CT-P27 and the CT-P59, in that an 
identical human immunoglobulin G1 Fc region backbone, the expected half-life of CT-P59 is 
18 days in human. 
The further nonclinical results of CT-P59 will be updated in the IB and will serve as the rationale 
behind dose selection. Safety data from cohort 1 and 2 (10 mg/kg, 20 mg/kg respectively) up to 
Day 7 in Study CT-P59 1.1 to be conducted in healthy subjects will be submitted for the 
regulatory’s review prior to the dosing of this study, Study CT-P59 1.2, in addition to the 
nonclinical data. The Data and Safety Monitoring Board (DSMB) members of the healthy and 
the mild patient studies (Studies CT-P59 1.1 and CT-P59 1.2, respectively) will consist of the 
same members and the DSMB will be required not to proceed with the dosing of the next cohort 
in the patient study if there is any safety concern raised in the dose already evaluated in healthy 
subjects. 
CT-P59 will be administrated intravenously. Several human antibodies are approved for IV 
infusion, which is the same route of administration of CT-P59. 
1.4 Benefit and Risk Assessment 
Despite the fact that numerous entities are under investigation, no potent and highly targeted 
antiviral options are available for treatment and/or prophylaxis of coronaviruses such as 
SARS-CoV-2 at present. 

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CT-P59 has not been administered in humans yet, and therefore, the benefits or risks in humans 
are unknown at this time. 
There may not be benefits for an individual patient, there may be benefits to society if a safe, 
efficacious therapeutic agent can be identified during this global SARS-CoV-2 infection 
outbreak. 
The same global independent DSMB will ensure continued review of emerging data for both 
Studies CT-P59 1.1 and CT-P59 1.2.  
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events (AEs) of CT-P59 may be found in the current version of the IB. 
The Sponsor will immediately notify the Principal Investigator if any additional safety or 
toxicology information becomes available during the study. 
This study will be performed in compliance with the protocol, International Council for 
Harmonisation (ICH) Good Clinical Practice (GCP) and applicable regulatory requirements. 
Aspects of the study concerned with the investigational medicinal product(s) will meet the 
requirements of European Union – Good Manufacturing Practice. 
The Sponsor and Investigator may take appropriate urgent safety measures in order to protect 
the patients of a clinical study against any immediate hazard to their health or safety. If such 
measures are taken, the Sponsor shall immediately give written notice to the licensing authority 
and the relevant ethics committee of the measures taken and the circumstances giving rise to 
those measures. 

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2 Study Objectives and Endpoints 
2.1 Study Objectives 
2.1.1 Primary Objective 
 
To evaluate the preliminary safety and tolerability of CT-P59 up to Day 14 of the last 
enrolled patient 
2.1.2 Secondary Objectives 
 
To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates 
 
To evaluate the efficacy of CT-P59 
 
To evaluate the PK of CT-P59 
 
To evaluate additional safety of CT-P59 including immunogenicity 
2.2 Study Endpoints 
2.2.1 Primary Endpoints 
Primary endpoints will be analyzed based on the data up to Day 14 of the last enrolled patient. 
 
Treatment-emergent adverse events (TEAEs) 
 
Treatment-emergent serious AEs (TESAEs) 
 
Treatment-emergent AEs of special interest (TEAESI; infusion related reactions including 
hypersensitivity/anaphylactic reaction) 
 
Potential effects on the incidence of antibody-dependent enhancement (ADE) 
 
Vital signs (blood pressure, heart rate, body temperature, SpO2 and respiratory rate) 
 
Hypersensitivity monitoring 
 
Twelve-lead electrocardiogram (ECG) 
 
Severe Acute Respiratory Syndrome Coronavirus infection related signs and symptoms 
 
Radiography (chest x-ray and/or chest CT) 
 
Clinical laboratory test (clinical chemistry, hematology, and urinalysis) 

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2.2.2 Secondary Endpoints 
Secondary virology, efficacy, PK, and safety endpoints will be analyzed. 
2.2.2.1 Virology 
 
Viral shedding in nasopharyngeal swab specimens based on quantitative polymerase chain 
reaction (qPCR) and cell culture 
 
Genotyping of SARS-CoV-2 viral isolates 
2.2.2.2 Efficacy 
 
Time to clinical recovery up to Day 28 
 
Proportion of patients with clinical recovery up to Day 7, 14, 28 
 
Proportion of patients requiring supplemental oxygen up to Day 7, 14, 28 
 
Proportion of patients with intensive care unit transfer up to Day 7, 14, 28 
 
Proportion of mechanical ventilation up to Day 7, 14, 28 
 
Proportion of patients with all-cause mortality up to Day 14, 28 
 
Proportion of patients with hospital admission up to Day 14, 28 
2.2.2.3 Pharmacokinetics 
 
Area under the concentration-time curve from time zero to infinity (AUC0-inf) 
 
Dose normalized AUC0-inf (AUC0-inf/Dose) 
 
Area under the concentration-time curve from time zero to the last quantifiable 
concentration (AUC0-last) 
 
Dose normalized AUC0-last (AUC0-last/Dose) 
 
Maximum serum concentration (Cmax) 
 
Dose normalized Cmax (Cmax/Dose) 
 
Time to Cmax (Tmax) 
 
Terminal half-life (t1/2) 

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 
Percentage of AUC0-inf obtained by extrapolation (%AUCext) 
 
Terminal elimination rate constant (λz) 
 
Total body clearance (CL) 
 
Volume of distribution during the elimination phase (Vz) 
2.2.2.4 Safety 
 
Treatment-emergent adverse events (TEAEs) 
 
Treatment-emergent serious AEs (TESAEs) 
 
Treatment-emergent AEs of special interest (TEAESI; infusion related reactions including 
hypersensitivity/anaphylactic reaction) 
 
Potential effects on the incidence of ADE 
 
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) 
 
Vital signs (blood pressure, heart rate, body temperature, SpO2 and respiratory rate) 
 
Hypersensitivity monitoring 
 
Twelve-lead electrocardiogram (ECG) 
 
Severe Acute Respiratory Syndrome Coronavirus infection related signs and symptoms 
 
Radiography (chest x-ray and/or chest CT) 
 
Clinical laboratory test (clinical chemistry, hematology, and urinalysis) 
 
Physical examinations 

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3 Investigational Plan 
3.1 Study Design 
This is a randomized, double-blind, placebo-controlled, parallel group, single ascending dose, 
Phase 1, pilot study to evaluate the safety, tolerability and virology of CT-P59 in combination 
with standard of care (SoC), except potential antiviral drugs and/or immune-based therapy 
under evaluation for treatment of SARS-CoV-2 infection, in patients with mild symptoms of 
SARS-CoV-2 infection. Approximately 18 patients in 3 cohorts are planned for enrollment and 
each cohort will consist of 6 patients, 5 of whom will receive CT-P59 and 1 of whom will receive 
a placebo. In each cohort, patients will be randomized in a 5:1 ratio to receive CT-P59 or placebo. 
This study will be started with the lowest dose that will maximize safety and the dose levels 
will be escalated to the higher doses. The details of dose escalation and stopping criteria is 
specified in Section 3.3. The overview of the study is presented in Figure 3-1. 
Figure 3-1 Study Overview 
 
The study will be performed in a double-blind manner. To minimize the risk of unblinding, the 
study drug will be dispensed by unblinded study center personnel. The unblinded personnel who 
are responsible for dispensing study drugs will not be permitted to conduct any patient 
assessments. 
3.2 Rationale for Study Design 
The design of this clinical trial follows the recommendation of the European Medicines Agency 
(EMA) Guideline on Strategies to identify and mitigate risks for first-in-human and early 
clinical trials with investigational medicinal product (EMA, 2017). 

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In line with the standard approach to early phase dose escalation study, the Sponsor is planning 
a pilot dose escalating Phase 1 study in patients with mild symptoms of SARS CoV-2 Infection 
to evaluate safety, tolerability and virology of CT-P59. 
The dose escalation study has been designed to carefully assess the safety and tolerability of 
CT-P59 in patients with mild symptoms of SARS-CoV-2 infection, before progressing into the 
subsequent studies. 
3.3 Dose Escalation and Stopping Criteria 
3.3.1 Dose Escalation Criteria 
After each study drug administration, patients will be observed for 48 hours for evaluation of 
the safety and tolerability of the study drug. Despite the relatively long expected half-life of 18 
days for CT-P59, the 48 hours of safety evaluation is justified given the expectation that any 
significant safety findings from the study drug administration should be apparent within post-
48 hours considering the study drug is IV infusion. 
When escalating dose from previous cohort to next cohort, Dose Escalation Committee (DEC) 
will review all available safety data of all patients in each cohort, within an observation period 
of 48 hours after study drug administration. If no safety or tolerability concern is observed, 
patients in next cohort will receive study drug. 
Patients will be admitted for 72 hours post-study drug administration, and the duration of 
hospitalization may be extended at the discretion of the Investigator, so safety will be 
continuously monitored after the observation period of 48 hours.  
If any safety concern including stopping rule specified in Section 3.3.2 is raised, study can be 
temporarily stopped and the case will be immediate escalated to be reviewed at a DSMB 
meeting. The appointed independent DSMB members will evaluate the relationship to CT-P59 
of the event with unblinded manner and review all available data and make a decision on 
continuation and the dose escalation of the study. 
3.3.2 Dose Stopping Rules 
The dose escalation from a previous cohort to the next cohort will be stopped if one or more of 
the following stopping criteria are met: 
 
Two or more patients in one cohort experience TEAEs of grade 3 or higher, which are 
considered to be related to study drug. 

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 
Four or more patients in one cohort experience TEAEs of grade 2 or higher, which are 
considered to be related to study drug. 
 
One or more patients in one cohort experience a TESAE, which are considered to be related 
to study drug. 
If an event corresponding to the above criteria occurs within the observation period of 48 hours 
in each cohort and the dosing is temporarily stopped under the decision of DEC, the appointed 
independent DSMB members will evaluate the relationship to CT-P59 of the event with 
unblinded manner and make a decision on continuation and the dose escalation of the study. 
If an event corresponding to the above criteria occurs after observation period of 48 hours in 
the previous cohort occurrence, further progression to next cohort will be temporarily stopped 
and the appointed independent DSMB members will review data and make a decision on 
continuation and the dose escalation of the study. 
If it was revealed that an event corresponding to the above criteria occurs and all the TEAEs are 
related to CT-P59 as reviewed by DSMB members, the study will be temporarily stopped. If it 
is decided to restart the trial and continue dose escalation based on further review of all available 
data, the supporting data will be submitted to the regulatory authority and agreed prior to trial 
restart. 
3.4 Study Overview 
The total duration of this study will be up to 27 weeks for the individual patient, including 
Screening Period and Follow-Up Period. All study procedures will be performed at the time 
points specified in Table 11-1 and Table 11-2. 
3.4.1 Screening Period (Day -7 to Day 1) 
Patients will sign and date the informed consent form (ICF) and undergo procedures to 
determine eligibility. 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 patient will be screen failed. Only one retest for reverse transcription 
polymerase chain reaction (RT-PCR) will be allowed, if study drug can be administered no more 
than 7 days from onset of symptom based on the retest results. And, if there is available RT-
PCR result confirming SARS-CoV-2 infection prior to obtaining written informed consent (but 
no more than 7 days from the onset of symptoms), the result can be allowed.  

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If Screening visit date and the administration of study drug date (Day 1) are same, all 
assessments scheduled for the Screening and Day 1 visit can be performed only once on the 
date before randomization. 
3.4.2 Treatment Period (Day 1 to prior to End-of-Treatment Visit) 
Inclusion and exclusion criteria will be re-confirmed on Day 1. If it is concluded that the patients 
are not eligible in Day 1 assessments, the patients will be considered as screening failure even 
if he/she was eligible based on assessments results performed during Screening Period. 
Patients will be randomized in 5:1 ratio to receive CT-P59 or placebo once all eligibility criteria 
have been confirmed. Patients will receive a single dose of CT-P59 or placebo on Day 1.  
All patients will be admitted to the study center on Day 1 and it is recommended to be confined 
up to Day 7. In-house stay period can be determined by Investigator considering the isolation 
regulation and/or public health capacity of the country, however all patients should be confined 
to the study center for at least 72 hours (until completion of all assessments on Day 3). 
After discharge, the consecutive study visits will be carried out on an out-patient basis. During 
the isolation period according to the local regulation, patients will visit the study center using 
the transportation provided by Sponsor. 
Patients will undergo the procedures at the time points specified in Table 11-1 and Table 11-2. 
3.4.3 End-of-Treatment Visit (Day 90) 
End-of-treatment (EOT) visit assessments will be performed on Day 90. Patients will undergo 
the assessments specified in Table 11-1 and Table 11-2. 
If a patient early terminated from the study, the patient will be asked to return to the study center 
for the safety assessments predefined on an EOT visit.  
3.4.4 Follow-Up Period (From End-of-Treatment Visit to Day 180) 
For all patients including a patient who early terminated from the study, if possible, each 
telephone call follow-up will occur bi-weekly from 2 weeks after the EOT visit to Day 180. 
During the Follow-Up Period, patients will be asked if they have any SARS-CoV-2 infection 
related signs and symptoms by telephone call to capture the suspicious ADE occurrence. For 
patients with suspicious ADE occurrence, all assessments specified in Table 11-2 will be 
conducted on unscheduled visit. 

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4 Patient Selection and Withdrawal Criteria 
4.1 Selection of Study Population 
It is expected that approximately 18 patients will be enrolled. Male or female patients aged 18 
to 60 years (both inclusive), with mild symptoms of SARS-CoV-2 infection diagnosed by 
RT-PCR and no more than 7 days prior to the study drug administration from the onset of 
symptom will be considered for enrollment in the study if they meet all of the inclusion criteria 
and none of the exclusion criteria. 
4.2 Inclusion Criteria 
Each patient must meet all of the following criteria to be randomized in this study: 
1. Adult male or female patient, aged between 18 to 60 years (both inclusive). 
2. Patient with laboratory confirmed SARS-CoV-2 infection by RT-PCR at Screening.  
Note: But, if the patient had RT-PCR result confirming SARS-CoV-2 infection prior to 
obtaining written informed consent (but no more than 7 days from the onset of symptoms), 
the result can be allowed. 
Note: During the Screening Period, only one retest for RT-PCR will be allowed, if study 
drug can be administered no more than 7 days from onset of symptom based on the retest 
results. 
3. Patient has mild conditions meeting all of the following criteria: 
a. Oxygen saturation ≥ 94% on room air. 
b. Not requiring supplemental oxygen. 
4. Patient has one or more of the following SARS-CoV-2 infection associated symptoms 
within 7 days prior to the study drug administration: 
a. Feeling feverish 
b. Cough 
c. Shortness of breath or difficulty breathing 
d. Sore throat 

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e. Body pain or muscle pain 
f. 
Fatigue 
g. Headache 
h. Chills 
i. 
Nasal obstruction or congestion 
j. 
Loss of taste or smell 
k. Nausea or vomiting 
l. 
Diarrhea 
5. Patient has one or more of the following SARS-CoV-2 infection associated symptoms 
present within 48 hours prior to the study drug administration: 
a. Feeling feverish 
b. Cough 
c. Shortness of breath or difficulty breathing 
d. Sore throat 
e. Body pain or muscle pain 
f. 
Fatigue 
g. Headache 
6. Onset of symptom is no more than 7 days prior to the study drug administration. Onset time 
of symptom is defined as the time when the patient experienced the presence of at least one 
symptom of the SARS-CoV-2 infection. 
7. Patient with a body weight between 50 kg and 100 kg (both inclusive) and a BMI of ≥ 18.0 
kg/m2. 
8. Patient is able to understand and to comply with protocol requirements, instructions, and 
restrictions. 

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9. Patient voluntarily agrees to participate in this study and has given a written informed 
consent prior to undergoing any of the Screening procedures. 
10. Patients and their partners of childbearing potential must agree to use a highly effective 
method of contraception or two acceptable methods of contraception until 6 months after 
the study drug administration as specified in Section 5.8.2. A woman is considered of 
childbearing following menarche and until becoming post-menopausal unless permanently 
sterile. A menopausal female must have no menses more than 12 months without an 
alternative medical cause prior to the date of informed consent to be classified as not of 
childbearing potential. A man is considered fertile after puberty unless permanently sterile 
by bilateral orchidectomy. Patients and their partners who have been surgically sterilized for 
less than 6 months prior to the date of informed consent must agree to use any medically 
acceptable methods of contraception. 
4.3 Exclusion Criteria 
A patient meeting any of the following criteria will be excluded from the study: 
1. Patient with severe condition meeting one of the following: 
a. Respiratory distress with respiratory rate ≥ 30 breaths/min. 
b. Requires supplemental oxygen. 
c. Experience shock. 
d. Complicated with other organs failure, and intensive care unit monitoring treatment is 
needed by investigator’s discretion. 
e. Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, 
in the opinion of the investigator, including but not limited to radiographic findings in 
lung. 
2. Patient has a medical history or current presence of disease including one or more of the 
following(s): 
a. Clinical hematology results of neutrophil count < 1.0×103 cells/µL (International 
System of units < 1.0×109 cells/L) at Screening and Day 1. 
b. Clinically significant condition of allergic reaction (e.g., urticaria, angio-oedema), 
atopic condition (asthma and eczematous dermatitis) in the investigator’s opinion 

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and/or hypersensitivity including known or suspected clinically relevant drug 
hypersensitivity to any monoclonal antibody or any components of study drugs. 
c. History of and/or current medical condition, classed as clinically significant by the 
investigator, including gastrointestinal, renal, endocrine, neurologic, autoimmune, 
hepatic, hematological, metabolic (including known diabetes mellitus), cardiovascular, 
or psychiatric condition. 
d. History or any concomitant active malignancy. 
e. History of and/or current infection with human immunodeficiency virus (HIV), 
hepatitis B or hepatitis C. 
f. 
History of serious infection (associated with hospitalization and/or which required 
intravenous antibiotics) within 6 months before the study drug administration and/or 
current infection, other than SARS-CoV-2 infection, requiring a course of systemic 
anti-infective therapy. 
g. History of an illness, other than SARS-CoV-2 infection, within 28 days prior to the 
study drug administration that is identified as clinically significant by the investigator 
and/or requires hospitalization. 
h. History of surgical intervention and/or an operation within 28 days prior to the study 
drug administration or plans to have a surgical procedure during the study period. 
3. Patient had a history of or concurrent use of medications including any prior therapy of 
following(s): 
a. Any vaccinations within 4 weeks prior to the study drug administration. 
b. Blood transfusion, or participated in another clinical trial within 3 months prior to the 
study drug administration. 
c. Treatment with any monoclonal antibody, fusion protein, or biologics within 6 months 
prior to the study drug administration. 
d. Any off-label or other investigational drugs prescribed for the treatment of 
SARS-CoV-2 infection. 
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of SARS-CoV-2 infection. 
f. 
Use of medications that are contraindicated with SoC. 
4. A male patient plans to father a child or donate sperm or a female patient is lactating or 
planning to be pregnant or to breastfeed within 6 months from the study drug administration. 
5. Patient shows reasonable evidence of drug/alcohol/nicotine abuse prior to the study drug 
administration as opinion of the Investigator or has following(s): 
a. Positive result for drug urine test during Screening and/or the opinion of the 
Investigator. 
b. History or presence of regular consumption exceeding an average weekly intake of 
> 14 units of alcohol in recent 3 months prior to the study drug administration. 
c. Consuming more than 10 cigarettes or equivalent per day within a month prior to the 
study drug administration. 
6. Patient is unwilling to avoid the use of alcohol or alcohol containing foods, medications, or 
beverage within 48 hours prior to admission and 24 hours prior to each study visit 
throughout the study or unable to refrain from smoking during the in-house stays. 
7. Patient donated or lost 400 mL or more whole blood within 8 weeks (plasma/platelets 
donation within 4 weeks) prior to the study drug administration. 
8. Patient shows evidence of a condition (psychological, emotional problems, any disorders 
or resultant therapy) that is likely to invalidate health information, consent, or limit the 
ability of the patient to comply with the protocol requirements in the opinion of the 
Investigator. 
9. Patient is vulnerable (e.g., employees of the clinical trial site 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). 
10. Patient is not likely to complete the study for whatever reason other than criteria listed 
above in the opinion of the Investigator. 

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4.4 Patient Withdrawal and Replacement 
Patients are free to withdraw from the study at any time for any reason. The Investigator may 
also discontinue the patient from the study at any time in the interest of patient safety. 
If premature withdrawal occurs for any reason, the Investigator must determine the primary 
reason for a patient’s premature withdrawal from the study and record this information in the 
patient’s medical record and in the electronic case report form (eCRF). The primary reasons for 
premature withdrawal are as following: 
 
Withdrawal of consent 
 
Lost to follow-up 
 
Adverse event 
 
Death 
 
Investigator’s decision 
 
Study termination by the Sponsor 
For patients who are lost to follow-up (i.e., those patients whose status is unclear because they 
fail to appear for study visits without stating an intention to withdraw), the Investigator should 
show due diligence by documenting in the source documents steps taken to contact the patients, 
e.g., dates of telephone calls, registered letters, etc. Patients who fail to return for final 
assessments will be contacted by the center in an attempt to have them comply with the protocol. 
The status of patients who fail to complete final assessments will be documented in the eCRF. 
When possible, the Sponsor should be notified of the withdrawal of a patient from the study. If 
necessary, the investigator may discuss with the Sponsor or its designee any patient’s reason for 
withdrawal from the study. The Sponsor may be contacted if clarification is required on a 
case-by-case basis. All patients who are terminated from the study will retain their patient 
identification number. 
4.4.1 Recruitment of Additional Patients 
Generally, patients who receive study drug and discontinue before the study completion will not 
be replaced. However, if a patient who receives the study drug discontinues the study for a 

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reason other than patient’s safety, the patient can be replaced upon decision of DEC. If a patient 
who is randomized but not receive study drug discontinues the study, the patient can be replaced.  
Patients who failed Screening, for any reason, can be rescreened only once. If there is unusual 
situation so that additional rescreening should be considered, the Investigator is recommended 
to discuss with the Sponsor. Rescreened patient will be assigned with new patient identification 
number. 
4.5 Premature Termination of the Clinical Trial 
Reason for premature termination of this study may include a failing to meet the requirements 
of regulatory authority, change in opinion of the independent ethics committee (IEC)/ 
institutional review board (IRB), unexpected or significant safety risk, or at the discretion of 
sponsor. An independent DSMB will thoroughly review and evaluate the safety data of study 
patients, and provide recommendations regarding the acceptability of continuing the study 
based on safety monitoring. 
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 patients will be kept fully informed 
and an appropriate follow-up examination of the patients will be arranged. The investigator will 
inform the Independent Ethics Committee (IEC; or Institutional Review Board, where 
applicable) of any premature termination or suspension of the study. 

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5 Study Treatment 
5.1 Method of Assigning Patients to Treatment Group 
Randomization will be performed using an interactive voice response system (IVRS) or 
interactive web response system (IWRS). Unblinded biostatisticians will generate the 
randomization schedule for IVRS or IWRS, which will link sequential patient randomization 
numbers to treatment codes. Patients will be allocated to each treatment group with the pre-
specified ratio.  
5.2 Treatment Administered 
On Day 1, patients who meet all of the inclusion and none of the exclusion criteria will be 
randomly assigned to one of 2 treatment groups, CT-P59 or placebo, according to randomization 
scheme. The CT-P59 or placebo will be administered as an IV infusion over 90 minutes (±15 
minutes) with SoC (except potential antiviral drugs and/or immune-based therapy under 
evaluation for treatment of SARS-CoV-2 infection). 
Patients in each cohort will receive study drug as follows: 
 
Cohort 1: CT-P59 20 mg/kg or placebo 
 
Cohort 2: CT-P59 40 mg/kg or placebo 
 
Cohort 3: CT-P59 80 mg/kg or placebo 
A 250 mL infusion solution of 0.9% weight/volume sodium chloride will be used for patient 
infusion. The bag will be gently inverted to mix the solution in order to avoid foaming. 
Parenteral solutions will be inspected visually for particulates and discoloration prior to 
administration and administration will not be performed if any particulates and discoloration 
are found. The detailed method about mixing the solution will be described in the pharmacy 
manual. 
When calculating total volume of study drug to be administered, the body weight of each patient 
measured on Day 1 will be used. Placebo will be administered as in the same volume as the 
active dose used for CT-P59 in each cohort. 
5.2.1 CT-P59 
CT-P59 is a monoclonal antibody which is being developed by the Sponsor as a potential 
treatment for SARS-CoV-2 infection. 

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CT-P59 is supplied as a sterile, preservative-free solution of SARS-CoV-2 RBD binding 
monoclonal antibody in a 20 mL single use vial for IV infusion. CT-P59 is a clear to opalescent, 
colorless to pale yellow solution for injection, with a pH of 6.0 and 960 mg of SARS-CoV-2 
RBD binding monoclonal antibody in 16 mL for IV infusion. One vial (16 mL) delivers 960 mg 
SARS-CoV-2 RBD binding monoclonal antibody, 13.12 mg of L-histidine, 15.84 mg of 
L-histidine monohydrochloride monohydrate, 8.0 mg of polysorbate 80, 505.584 mg of 
L-Arginine monohydrochloride, and water for injection. The container closure system includes 
type I borosilicate glass vial, Fluroetec Film coated rubber stopper and flip-off type aluminum 
cap. 
5.2.2 Placebo 
Placebo contains the same ingredient as the CT-P59 formulation listed in Section 5.2.1, 
excluding SARS-CoV-2 RBD binding monoclonal antibody. Each placebo vial contains 
13.12 mg of L-histidine, 15.84 mg of L-histidine monohydrochloride monohydrate, 8.0 mg of 
polysorbate 80, and 505.584 mg of L-Arginine monohydrochloride, and water for injection in 
16 mL. The pH of the placebo solution is 6.0. The container closure system includes type I 
borosilicate glass vial, Fluroetec Film coated rubber stopper and flip-off type aluminum cap. 
5.2.3 Dose Modification 
No dose modifications or dose omissions are permitted for CT-P59 or placebo. 
5.3 Management of Clinical Supplies 
5.3.1 Study Drug Packaging, Labeling, and Storage 
The Sponsor will provide the Investigator and study center with adequate quantities of CT-P59 
and placebo. A label will be attached to the outside of each patient 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 
 
Patient number/site number 
 
Contents and quantity 
 
Lot number 
 
Randomization code/kit number 

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 
Investigator’s name 
 
Route of administration 
 
Directions for use 
 
Storage instructions 
 
Caution statement (for clinical study use only) 
 
Sponsor’s contact name and address 
 
Expiry date 
CT-P59 drug product in a vial should be stored in a refrigerator between 2°C and 8°C and not 
frozen. It should be kept in its original outer packaging to protect it from light and it should not 
be shaken. 
5.3.2 Study Drug Accountability 
It is the responsibility of the clinical Investigator to ensure that all study drug received at the 
study center will be inventoried and accounted for throughout the study and the result recorded 
in the drug accountability form maintained at the study center. The study drug accountability 
will be verified by the monitor during on-site monitoring visits. In case an on-site monitoring 
visit cannot be made because of the SARS-CoV-2 pandemic situation, the Sponsor and contract 
research organization (CRO) will discuss with the Investigator. Study drug will be stored in a 
limited-access area or in a locked cabinet under appropriate environmental conditions. 
The Investigator agrees not to supply the study drug to any person other than sub-Investigators, 
designated staffs, and the patients participating in the study. Study drug may not be relabeled or 
reassigned for use by another patients unless approved by the Sponsor. 
The Investigator will return or destroy all study drugs according to the pharmacy manual. The 
Investigator will destroy empty or partially used vials in a blinded manner as well as its cartons 
after reconstitution per the center’s standard operating procedures (SOPs), and keep tear-off 
labels for accountability. This authorization may also be granted to destroy used vials 
immediately after administering to patients. The list of destroyed vials must be recorded. The 
Investigator agrees to neither dispense the study drug from, nor store it at, any study center other 
than the study center agreed upon with the Sponsor. Details on study drugs accountability and 
destruction will be followed according to the pharmacy manual. 

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5.4 Blinding 
This study will be double-blind until the end of the study. The randomization codes will not be 
revealed to study patients, Investigator, and study center personnel, except for delegated 
unblinded staff who will handle the study drug and predefined unblinded teams in the Sponsor 
and CRO until all final clinical data have been entered into the database and the database is 
locked and released for analysis. 
Pharmacy personnel (trained by a delegated pharmacist) at the study center who has no other 
patient contact and who is not directly involved with the clinical aspects of the study will prepare 
and dispense the study medication and will be aware of the randomization code. All study drugs 
will be delivered to the study center and will be assigned to treatment groups by the pharmacy 
personnel in accordance with the provided randomization schedule. The pharmacy personnel 
will also be provided kit list that provides the kit number and corresponding treatment arm. The 
pharmacy personnel will select the kit based on the randomization and kit lists provided. All 
study drugs will be supplied to the trained clinical staff member in a sealed carton marked with 
the kit number. 
5.5 Breaking the Blind 
Under normal circumstances, the blind should not be broken. The blind should only be broken 
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 emergency, determine 
the identity of the study drug by using the IWRS (or applicable procedure if IWRS is not 
available). 
The date, time and reason for the unblinding must be documented in the source document and 
the appropriate field of the eCRF and the medical monitor will be informed as soon as possible. 
All unblinding events will be reported to the medical monitor and the Sponsor. Any patients for 
whom the blind is broken may continue in the study at the investigator’s discretion. 
The DSMB and the statistician(s) who provides the safety analyses for the DSMB will also be 
unblinded upon the request from DSMB members during closed session. 
The overall randomization code will be broken only for reporting purposes. This will occur after 
database lock for data up to Day 14 of the last enrolled patient. The unblinded personnel will be 
predefined and documented before performing the analyses.  

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5.6 Treatment Compliance 
Patient compliance will be determined based on drug accountability as well as source 
documents. The date and time of the study drug administration will be documented and every 
effort will be made to encourage the patients’ compliance with the study visits. 
5.7 Prior, Concomitant, and Prohibited Medications 
Prior and concomitant medication will be recorded for the 30 days prior to the patient signs the 
ICF (inclusive of the applicable periods for prohibited medication as defined in Section 4.3) 
until the EOT. Use of SoC will also be properly recorded. Concomitant medication is permitted 
if indicated by the Investigator for treatment of AE.  
Prohibited medications during the study include the following: 
 
Any vaccinations 
 
Blood transfusion, or participated in another clinical trial 
 
Treatment with any monoclonal antibody or fusion protein, or use of biologics 
 
Any off-label or other investigational drugs prescribed for the treatment of SARS-CoV-2 
infection 
 
Potential antiviral drugs and/or immune-based therapy under evaluation for treatment of 
SARS-CoV-2 infection 
 
Use of medications that are contraindicated with SoC 
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 Restriction 
The Investigator, or delegated clinical staff member, will check if patient is complying with 
these restraints during the study. 
5.8.1 Dietary and Fluid Restrictions 
Alcohol: 
Alcohol containing products (including alcohol, alcohol-containing foods, 
medications, or beverages) must be avoided from 48 hours before the 
study drug administration and 24 hours before any study visit and while 

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patients are confined to the study center. Patients must abstain from 
alcohol-containing products for 24 hours prior to each PK sampling time 
point. Patient will not exceed an alcohol consumption of 14 units per week 
until the end of the study period. One standard unit is equal to 
approximately 285 mL of full strength beer (4.8% alcohol by volume 
[ABV]), 30 mL of spirits (40% ABV), or 100 mL of wine (13.5% ABV). 
Caffeine: 
Patients will not be permitted to drink caffeine or xanthine-containing 
products (e.g., coffee, black tea, cola, etc., or use caffeine or xanthine-
containing products) for 24 hours prior to the study drug administration 
and during the confinement period of the study. Patients must abstain from 
caffeine or xanthine-containing products for 24 hours prior to each PK 
sampling time point. 
Nicotine: 
Patients will be permitted to smoke less than 10 cigarettes or equivalent 
per day until the end of the study period, but will not be allowed to smoke 
during the confinement period of the study. 
Meals: 
Patients must abstain from all food and drink (except water) at least 8 
hours prior to the study drug administration and at least 4 hours prior to 
any safety laboratory evaluations. Water is permitted until 1 hour prior to 
the study drug administration and may be consumed without restriction 
beginning 1 hour after the study drug administration. No outside food or 
drink is permitted at the study center. All meals will be provided by the 
study center. 
5.8.2 Other Restrictions 
Activity: 
Strenuous activity (e.g., heavy lifting, weight training, calisthenics, and 
aerobics) is prohibited from 72 hours prior to admission until discharge. 
After discharge, mild physical activity can be resumed, but strenuous 
physical activity is prohibited 72 hours prior to each study visit. 
Hygiene: 
Patients should follow the country/local guideline for SARS-CoV-2 
infection prevention. 
Medications: 
Restrictions on medication during the study is described in Section 5.7. 

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Lactation: 
Female patients are prohibited to breastfeed until 6 months from the study 
drug administration. 
Contraception: 
A woman is considered of childbearing following menarche and until 
becoming post-menopausal unless permanently sterile. A menopausal 
female must have no menses more than 12 months without an alternative 
medical cause prior to the date of informed consent to be classified as not 
of childbearing potential. A man is considered fertile after puberty unless 
permanently sterile by bilateral orchidectomy.  
 
Patients and their partners of childbearing potential must agree to use a 
highly effective method of contraception or two acceptable methods of 
contraception (e.g., male or female condom AND additional hormonal or 
barrier contraceptive method by female partner) consistent with local 
regulations until 6 months after the study drug administration regardless 
of patient withdrawal.  
 
A highly effective method of birth control may be defined as those which 
result in a low failure rate (e.g., <1% per year, when used consistently and 
correctly). Examples of acceptable forms of highly effective contraception 
for female patients include the following: 
 
- 
Combined (estrogen and progestogen containing) hormonal 
contraception associated with inhibition of ovulation  
- 
Progestogen-only hormonal contraception associated with inhibition 
of ovulation 
- 
Intrauterine devices  
- 
Intrauterine hormone-releasing system 
- 
Bilateral tubal occulusion  
- 
Vasectomized partner  
- 
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 
of the duration of exposure to investigational drug, and withdrawal 
are not acceptable methods of contraception  

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- 
Spermicide condom (condoms coated with spermicide) use alone is 
not allowed 
 

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6 Study Assessments and Procedures 
Before performing any study procedures, all potential patients will be informed of the full nature 
and purpose of the study, including possible risks and side effects, and given ample time and 
opportunity to read and understand this information, before signing and dating the ICF. The 
Investigator will respond to any questions raised by the patient. The Investigator will also sign 
the ICF. 
Patients will undergo the procedures at the time points specified in Table 11-1 and Table 11-2. 
6.1 Safety Assessments 
Safety assessments include monitoring of AEs (including SAEs and AESI [infusion related 
reactions including hypersensitivity and anaphylactic reactions]), potential effects on the 
incidence of ADE, immunogenicity including ADAs and NAbs, vital signs, hypersensitivity 
monitoring, 12-lead ECG, SARS-CoV-2 infection related signs and symptoms, radiography, 
physical examination, clinical laboratory tests, pregnancy tests, and prior and concomitant 
medications. 
6.1.1 Adverse Events 
6.1.1.1 Definition of Adverse Events 
An adverse event (AE) is defined as any untoward medical occurrence in any patient during the 
study which does not necessarily have a causal relationship with the study drug. Any new 
condition noted at Screening would be regarded as an AE, but not a TEAE. 
Adverse events requiring therapy must be treated with recognized standards of medical care to 
protect the health and well-being of the patient. Treatment due to an AE will be recorded. 
A treatment-emergent AE (TEAE) includes any untoward medical occurrence in a patient after 
administration of a study drug, which does not necessarily have to have a causal relationship 
with this the study drug. A TEAE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease temporally associated with the 
use of the product, whether or not related to the study drug. 
Abnormal results of diagnostic procedures including laboratory test abnormalities are 
considered as AEs if they fulfill the following criteria: 
 
Result in discontinuation from the study drug 

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 
Require treatment or any other therapeutic intervention 
 
Require further diagnostic evaluation (excluding a repetition of the same procedure to 
confirm the abnormality) 
 
Are clinically significant as evaluated by the Investigator 
Medical intervention 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 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. 
6.1.1.1.1 Serious Adverse Events 
An SAE is defined as any untoward medical occurrence that at any dose: 
 
Results in death. 
 
Is life-threatening (refers to an AE in which the patient was at immediate risk of death at 
the time of event). It does not refer to an event which may have caused death, if it was more 
severe. 
 
Requires inpatient hospitalization or prolongation of existing hospitalization. 
 
Results in persistent or significant disability/incapacity. 
 
Is a congenital anomaly/birth defect. 
Medical and scientific judgment should be exercised in deciding whether expedited reporting is 
appropriate in other situations, such as important medical events that may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may 
require medical or surgical intervention to prevent one of the outcomes listed in the definition 
above. These should also be considered serious. 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 inpatient hospitalization, or the development of 
drug dependency or drug abuse. 
Adverse events associated with hospitalization or prolongations of hospitalization are 
considered as SAEs. Any admission (even if < 24 hours) to a healthcare facility meets these 
criteria. Admission also includes transfer within the hospital to an acute/intensive care unit (e.g., 

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from the psychiatric wing to a medical floor, from medical floor to a coronary care unit, from 
neurological floor to a tuberculosis 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 (for work-up of persistent 
pre-treatment laboratory abnormality) 
 
Social admission (e.g., patient has no place to sleep) 
 
Purely for convenience (e.g., for easier performance of study assessments) 
 
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 
cosmetic surgery) 
 
Hospitalization for observation without a medical AE 
 
Pre-planned treatments or surgical procedures; these should be noted in the baseline 
documentation for the entire protocol and/or for the individual patient 
6.1.1.1.2 Unlisted (Unexpected) Serious Adverse Events 
An unlisted or 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. 
6.1.1.1.3 Suspected Unexpected Serious Adverse Reactions 
The Sponsor will promptly evaluate all suspected unexpected serious adverse reactions against 
cumulative product experience to identify and expeditiously communicate possible new safety 
findings to Investigators, IECs, and applicable health authorities based on applicable legislation. 
To determine reporting requirements for single SAE cases, the Sponsor will assess the 
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Reporting requirements will also be based on the Investigator’s assessment of causality and 
seriousness, with allowance for upgrading by the Sponsor as needed. 
6.1.1.1.4 Adverse Events of Special Interest 
Infusion related reaction including hypersensitivity/anaphylactic reactions is considered as 
AESI because AE related to infusion related reactions (hypersensitivity/anaphylactic reactions) 
is typical of monoclonal antibody therapy, and will be reported using the same process as for 
AEs.  
6.1.1.1.5 Eliciting and Documenting Adverse Events 
All AEs will be reported by the Investigator via eCRF from the date patients signs the ICF until 
EOT visit, regardless of the relationship to the study drug. The condition of the patient will be 
monitored throughout the study for any signs or symptoms. 
At every study visit, patient will be asked a standard nonleading 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 medications and over-the-counter drugs). 
In addition to patient observations, AEs identified from any study data (e.g., laboratory values, 
physical examination findings, ECG changes) or identified from review of other documents that 
are relevant to patient safety will be documented on the AE page in the eCRF. 
6.1.1.1.6 Reporting Adverse Events 
All AEs reported or observed during the study will be recorded on the AE page in the eCRF and 
source documents. Information to be collected includes drug treatment, action taken with study 
drug, event term, date/time of onset and end date, Investigator-specified assessment of severity 
and relationship to study drug, seriousness of AE, any required treatment or evaluations, and 
outcome. 
Adverse events resulting from concurrent illness, reactions to concurrent illnesses, or reactions 
to concurrent medications must also be reported from the date patients signs the ICF until EOT 
visit. Adverse events will be graded for severity according to the Common Terminology Criteria 
for Adverse Events (CTCAE) Version 5.0. The Medical Dictionary for Regulatory Activities 
will be used to code all AEs. 

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Any medical condition that is present at the time that the patient is screened but does not 
deteriorate should not be reported as an AE. However, if it deteriorates at any time during the 
study, it should 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 Section 6.1.1.2 and Section 6.1.1.3, respectively. 
6.1.1.1.7 Reporting Serious Adverse Events 
Any AE considered serious by the Investigator or which meets SAE criteria (Section 6.1.1.1.1) 
must be reported to CRO within 24 hours from the time study center staff first learn about the 
event. 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 email it 
to CRO 
 or via FAX (details on SAE report form) within 24 hours 
of awareness of the event. The remote data capture system should be updated as soon as it is 
available. Withdrawal from the study and all therapeutic measures will be at the discretion of 
the Principal Investigator or Sub-Investigator. All SAEs will be followed up as specified in 
Section 6.1.1.1.8. 
The Sponsor 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. 
The Sponsor or its designee is responsible for reporting fatal or life-threatening suspected 
unexpected serious adverse reaction (expedited reports) to the regulatory agencies and 
competent authorities within 7 calendar days after being notified of the event. The Sponsor 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 IECs by a 
written safety report within 15 calendar days of notification. 

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6.1.1.1.8 Follow-up of Adverse Events 
All reported AEs will be followed until one of the following: resolution or improvement from 
baseline, confirmed by the Investigator that no further improvement could be expected, no more 
collection of clinical or safety data, or final database closure. For patients who withdraw from 
the study, the last assessed status of AEs will be collected. 
6.1.1.2 Assessment of Severity 
The severity of an AE refers to the extent to which an AE affects the patient’s daily activities. 
The severity of the AE will be graded based on the CTCAE Version 5.0, based on the following 
general guidelines (a semicolon indicates “or” within each description): 
Grade 1: 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated 
Grade 2: 
Moderate; minimal, local or noninvasive intervention indicated; limiting 
age appropriate instrumental activities of daily living (ADL)1 
Grade 3: 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; 
limiting self-care ADL2 
Grade 4: 
Life-threatening consequences; urgent intervention indicated 
Grade 5: 
Death related to AE 
1. Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. 
2. Self-care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not 
bedridden. 
Changes in the severity of an AE should 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 nonserious 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. 
6.1.1.3 Assessment of Causality 
As discussed in Section 6.1.1.1.6, 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 study drug 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, e.g., the events 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 states, or concurrent medication reaction) 
do not appear to explain the event. The event reappears or worsens if the study 
drug is re-administered. 
6.1.2 Medical History and Demographic Information 
Medical history and demographic information (age, sex, ethnicity, and race) will be recorded 
on both the source documents and eCRF. 
6.1.3 Viral Serology Test 
Viral serology tests including hepatitis B surface antigen (HBsAg), hepatitis B core antibody 
(HBcAb), hepatitis C antibody, and HIV-1 and -2 tests will be performed at Screening visit. If 
the HBsAg test result is positive, the patient cannot be enrolled in the study. If the HBcAb test 
result is positive, the patient also cannot be enrolled. If the hepatitis C antibody, HIV-1 and -2 
test result is a positive, the patient also cannot be enrolled in the study. 

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6.1.4 Urine Drug Test 
An urine drug tests will be performed at Screening. The screen for drug abuse includes 
methamphetamine, barbiturates, benzodiazepines, cocaine, tetrahydrocannabinol, and opiates. 
The urine test can be repeated once at the discretion of the Investigator. 
6.1.5 Hypersensitivity Monitoring 
Hypersensitivity monitoring will be performed as specified in Table 6-1. 
Table 6-1 Schedule of Assessments for Hypersensitivity Monitoring 
Day 
Time points 
Window 
Day 1 
Predose 
Within 30 minutes 
15 minutes from start of infusion 
± 5 minutes 
30 minutes from start of infusion 
60 minutes from start of infusion 
90 minutes from start of infusion 
2 hours from start of infusion 
± 15 minutes 
3 hours from start of infusion 
6 hours from start of infusion 
12 hours from start of infusion 
Day 2 
24 hours from start of infusion 
± 30 minutes 
Hypersensitivity will be assessed by additional vital signs measurements including blood 
pressure, heart rate, respiratory rate, and body temperature. In addition, hypersensitivity 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/or artificial ventilation will be available and 
any type of ECG can be performed if a patient experiences cardiac symptoms. 
For patients who experience or develop life threatening treatment-related hypersensitivity 
reactions, study drug must be stopped immediately. 
Details will be recorded in both the source documents and the eCRF. 
6.1.6 Vital Signs, Weight, and Height 
Vital signs and weight measurements will be performed at the time points specified in 
Table 11-1 and Table 11-2. Vital signs (including blood pressure, heart rates, respiratory rates, 

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body temperature and SpO2) will be measured after the patient has rested quietly for at least 5 
minutes. SpO2 will be measured while breathing normal room air. Body temperature will be 
measured using tympanic thermometer throughout the study. Height and BMI will be assessed 
at Screening only as a baseline measurement. Details will be recorded in both the eCRFs and 
source documents. 
Additional vital sign measurements will also be monitored before and after the study drug 
administration as part of the hypersensitivity monitoring (Section 6.1.5). 
6.1.7 Electrocardiogram 
A 12-lead ECG will be performed at the time points specified in Table 11-1 and Table 11-2 and 
if the patient experienced cardiac symptoms during study drug administration. All scheduled 
12-lead ECGs will be performed after the patient has rested quietly for at least 5 minutes. If 
following the ECG review by the Investigator there are any ECG findings that would indicate 
cardiac insufficiency or QT prolongation or any other abnormalities, the patient will be referred 
to a cardiologist if required, to confirm the abnormality. The Investigator will then report the 
event in the eCRF and source documents. Regardless of 12-lead ECG result, further evaluation 
with a cardiologist can be performed at the Investigator’s discretion. 
In case of hypersensitivity monitoring, any type of ECG can be performed (Section 6.1.5). 
6.1.8 Physical Examination 
Physical examinations will be performed at time points specified in Table 11-1. The physical 
examination includes an assessment of general appearance and a review of systems. Information 
about the physical examination will be recorded by the Investigator, or delegated clinical staff 
member, 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. 
6.1.9 Pregnancy 
Serum pregnancy test will be performed for female patients with childbearing potential at 
Screening and EOT visit as specified in Table 11-1. Only patients who are confirmed as 
nonpregnant can be enrolled in the study. 
The serum pregnancy test samples will be analyzed at the local laboratory. If serum pregnancy 
test is unavailable, urine pregnancy test can be performed instead. 

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In an event of unexpected pregnancy within 6 months after the study drug administration, 
patients will be counselled to inform the Investigator. If a female patient or female partner of a 
male patient becomes pregnant, the pregnancy must be reported to the Sponsor and CRO within 
24 hours of the study center’s knowledge of the likelihood of pregnancy while confirmation is 
pending. The study center must complete the supplied pregnancy form and return it to the 
Sponsor and CRO within 24 hours of pregnancy being detected. 
Pregnant patients or partners of patients 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. 
In female patients or female partners of patients, abnormal pregnancy outcomes (e.g., 
spontaneous abortion, fetal death, stillbirth, congenital anomalies, and ectopic pregnancy) are 
considered SAEs. Any SAE that occurs during pregnancy (e.g., maternal serious complications, 
ectopic pregnancy, stillbirth, neonatal death, congenital anomaly, birth defect) must be reported 
within 24 hours in accordance with the procedure for reporting SAEs (Section 6.1.1.1.7). 
6.1.10 Radiography 
Radiography (chest x-ray and/or chest CT) will be performed at the scheduled time points 
specified in Table 11-1 and when the Investigator considers it is clinically necessary (e.g., 
abnormal findings of SpO2). 
6.1.11 Clinical Laboratory Analyses 
Blood and urine samples for clinical laboratory assessments including clinical chemistry, 
hematology, and urinalysis will be collected at the time points specified in Table 11-1 and Table 
11-2. Laboratory analyses will be performed by the local laboratories. 
The following clinical laboratory analyses will be performed. 
Clinical chemistry: 
Total protein, serum bilirubin (total, direct), ALT, AST, alkaline 
phosphatase, γ-glutamyl transferase, blood urea nitrogen, creatinine, 
creatine kinase, creatine kinase-myocardial band isoenzyme, troponin 
(I or T, [only one applicable]), albumin, sodium, potassium, calcium, 
chloride, inorganic phosphorus, glucose, lactate dehydrogenase, total 
cholesterol, triglyceride, high-density lipoprotein cholesterol, and 
CRP 

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Hematology: 
Red blood cells, erythrocyte sedimentation rate, total white blood cell 
count, absolute neutrophil count, eosinophil count, lymphocyte count, 
platelet count, hemoglobin, mean corpuscular volume, mean 
corpuscular 
hemoglobin, 
mean 
corpuscular 
hemoglobin 
concentration, and hematocrit 
Urinalysis: 
Bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, 
specific gravity, urobilinogen, and microscopic examination of white 
blood cell count, red blood cell count, and bacteria 
6.1.12 Immunogenicity Assessments 
The immunogenicity of CT-59 will be assessed by ADA and NAb test in validated immunoassay. 
Blood samples for immunogenicity assessments will be collected at the time points specified in 
Table 11-1. If the blood sample is unable to be analyzed or is missing at certain time point, some 
blood samples collected for PK assessment at the same time point can be used for 
immunogenicity 
assessment. Additional 
immunogenicity 
will 
be 
assessed 
when 
immune-related AEs occurs. 
Analysis will be performed at the central laboratory. 
6.1.13 SARS-CoV-2 Infection Related Signs and Symptoms 
During the Screening, Treatment Period, and EOT visit, the Investigator or designee will 
perform a respiratory signs and symptoms assessment (which should include, at a minimum, 
the examination of ear, nose, throat, sinuses, and lungs) and assessment for non-respiratory signs 
and symptoms and/or potential complications of SARS-CoV-2 infection. During the Follow-Up 
Period, patients will be asked if they have any SARS-Cov-2 infection related signs and 
symptoms by telephone call. The assessment will be performed at the scheduled time points 
specified in Table 11-1 and Table 11-2.  
Any signs and symptoms of SARS-CoV-2 infection captured on SARS-CoV-2 infection related 
signs and symptoms will be reported as AEs at the discretion of the Investigator. 
6.1.14 Potential Effects on the Incidence of Antibody-dependent 
Enhancement 
Occurrence of ADE of SARS-CoV-2 infection may advocate cautious development of SARS-
CoV-2 antibody in human, and provide new ways of investigation to understand the 
pathogenesis of SARS.  

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Patients will be monitored for symptoms and levels of viral shedding suggestive of suspicious 
ADE throughout the study. 
Patients will be considered to possibly have ADE if they meet any of the following criteria: 
 
If a patient has excessive progression of symptoms regarded as related to viral infection 
(e.g., excessive infiltration of inflammatory cells in the lung), OR 
 
If a patient has other SARS-CoV-2 infection related signs and symptoms which are 
judged as possible manifestations of ADE according to the medical opinion of the 
Investigator. 
If a patient meets any of the criteria for suspicious ADE, additional evaluations will be 
performed as specified in Table 11-2 during the Treatment Period, EOT, and Follow-Up Period. 
The patient will need to record the patient diary for SARS-CoV-2 Infection Symptom Checklist 
for 7 days from the day of suspicious ADE occurrence. If symptoms have not resolved or have 
worsened up to Day 7 after the day of suspicious ADE occurrence, same procedure will be 
repeated until when the symptoms are resolved and/or no SARS-CoV-2 infection is confirmed 
by RT-PCT (local). 
6.2 Virology Assessments 
Viral shedding (qPCR and cell culture) and genotyping will be performed using the 
nasopharyngeal swab samples. Samples will be secured at the central laboratory for analysis 
and backup samples will be retained. 
Details of nasopharyngeal swab sampling time points and acceptable tolerance windows for 
virology assessments are described in Table 6-2. 
 

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Table 6-2 Nasopharyngeal Swap Sampling Time Points for Virology Assessment 
Day 
Time point 
Window 
Screening* 
Anytime 
Day -7 to Day 1 
Day 1* 
Predose 
Predose within the day 
Day 2 
24 hours after start of infusion 
± 4 hours 
Day 3 
48 hours after start of infusion 
Day 4 
72 hours after start of infusion 
Day 5 
96 hours after start of infusion 
Day 6 
120 hours after start of infusion 
Day 7 
144 hours after start of infusion 
Day 10 
216 hours after start of infusion 
Day 14 
312 hours after start of infusion 
± 1 day 
Day 21 
480 hours after start of infusion 
Day 28 
648 hours after start of infusion 
± 3 days 
* If Screening and administration of study drug are occurred on the same day, sampling of nasopharyngeal swab 
will be performed twice both for RT-PCR (local) of Screening and viral shedding and genotype (central) of Day 1, 
respectively. 
6.3 Efficacy Assessments 
6.3.1 Patient Diary for SARS-CoV-2 Infection Symptom Checklist 
All patients will be issued a patient diary for SARS-CoV-2 Infection Symptom Checklist at 
Screening and will be required to record it daily from Day 1 until clinical recovery or Day 28, 
whichever comes first. Patients will be instructed to complete the diary twice a day at 
approximately 12-hour intervals in the morning (between 6 and 10 AM, approximately) and in 
the evening (between 6 and 10 PM, approximately). The patient diary will be recorded once at 
Screening. On the date of study drug administration (Day 1), the patient diary will be recorded 
twice before and after the study drug administration. 
The study site staff will instruct the patients on the use of the diary. Patients will be told to bring 
their completed diary each time they return to the study site. Study staff will review the entries 
in the diary at each study visit. If the patient is not compliant in regard to filling out the diary 
(omissions, discrepancies, or other difficulties), instructions on how to use the diary may be 
repeated. Study site staff should encourage the patient to complete the diary and remind the 
patient of the importance of following study procedures while at home. 
SARS-CoV-2 Infection Symptom Checklist consists of 7 symptoms and the intensity of 
patient’s self-aware for each SARS-CoV-2 infection symptom. The 7 symptoms of SARS-CoV-

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2 infection are feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, 
body pain or muscle pain, fatigue, and headache. Scores for SARS-CoV-2 infection symptom 
are absent (0), mild (1), moderate (2), and severe (3).  
A full SARS-CoV-2 Infection Symptom Checklist is described in Section 11.2. 
Clinical recovery is defined by all symptoms on the SARS-CoV-2 Infection Symptom Checklist 
will be recorded as ‘absent or mild in intensity’ for at least 24 hours. To satisfy the clinical 
recovery, symptoms of the moderate or severe in intensity at Screening should be scored as mild 
or absent, or symptoms of the mild or absent in intensity at Screening should be scored as absent, 
after study treatment. 
After Day 28, additional recording of the diary will be required if following conditions are met: 
 
For patients who will achieve clinical recovery at Day 28, patients will record the diary 
until Day 29 to confirm whether it is maintained at least 24 hours. 
 
For patients who will show deterioration (at the discretion of the Investigator) after the 
achievement of clinical recovery, patient will record the diary until secondary 
achievement of clinical recovery. 
 
After Day 28 of regular scheduled study visit, for patients with suspicious ADE 
occurrence, patient will record the diary for 7 days from the day of suspicious ADE 
occurrence (specified in Table 11-2). 
However, if patient’s condition is not available to record the diary at the discretion of 
Investigator (e.g. sedation state for mechanical ventilator therapy), recording can be 
discontinued. Any signs and symptoms of SARS-CoV-2 infection throughout the study, 
including the Screening Period, will be captured on the patient diary for SARS-CoV-2 Infection 
Symptom Checklist and the symptoms recorded on this diary will not be reported as AEs.  
All information obtained from the diary will be entered to the eCRF. These results will be used 
in the assessment of clinical recovery as secondary efficacy endpoints (see Section 2.2.2.2). 
6.3.2 Disease Status Monitoring 
Disease status including requirement of supplemental oxygen, intensive care unit transfer, 
mechanical ventilation use, and hospitalization will be monitored during the study period 
(from signing of ICF to EOT). 

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6.3.2.1 Requirement of supplemental oxygen 
The information of supplemental oxygen during the study period (from signing of ICF to EOT) 
will be recorded in the eCRF and source documents. Information to be collected includes the 
start and end date of supplemental oxygen. 
6.3.2.2 Intensive care unit transfer 
The information of intensive care unit transfer during the study period (from signing of ICF to 
EOT) will be recorded in the eCRF and source documents. Information to be collected includes 
the transfer and discharge date for the intensive care unit. 
6.3.2.3 Mechanical ventilation use 
The information of mechanical ventilation use during the study period (from signing of ICF to 
EOT) will be recorded in the eCRF and source documents. Information to be collected includes 
the start and end date of mechanical ventilation use. 
6.3.2.4 Hospitalization 
The information of hospitalization except the in-house stay according to the Section 3.4.2  
during the study period (from signing of ICF to EOT) will be recorded in the eCRF and source 
documents. Information to be collected includes the start and end date of hospitalization. 
6.4 Pharmacokinetic Assessments 
Details of blood sampling time points and acceptable tolerance windows for PK assessments 
are described in Table 6-3. 
Table 6-3 Blood Sampling Time Points for Pharmacokinetic Assessment 
Day 
Time point 
Window 
Day 1 
Predose 
Predose within the day 
End of infusion 
+ 15 minutes 
1 hour after end of infusion 
Day 2 
24 hours after start of infusion 
± 1 hour 
Day 3 
48 hours after start of infusion 
Day 5 
96 hours after start of infusion 
± 4 hours 
Day 7 
144 hours after start of infusion 
Day 10 
216 hours after start of infusion 
Day 14 
312 hours after start of infusion 
± 1 day 
Day 28 
648 hours after start of infusion 
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Day 56 
1,320 hours after start of infusion 
± 5 days 
Day 90/EOT visit 
2,136 hours after start of infusion 
If the blood sample is unable to be analyzed or is missing at certain time point, some blood 
samples collected for immunogenicity assessment at same time point can be used for PK 
assessment. Analysis will be performed at the central laboratory. 
Instructions for the blood collection, storage, and shipment to the central laboratory are 
described in Section 6.5 and Section 6.6. 
6.5 Sample Collection 
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. All samples should be collected as close as possible to the 
scheduled time point, and the actual sampling date must be recorded in both the source 
documents and the eCRF. 
6.5.1 Pharmacokinetic Blood Sampling 
Blood samples for PK assessments will be obtained in accordance with the laboratory manual 
from each patient at the time point specified in Table 6-3. All samples should be collected as 
close as possible to the scheduled time point. The actual sampling date and time will be recorded 
in both the eCRF and source documents. 
6.5.2 Immunogenicity Blood Sampling 
Blood samples for immunogenicity assessments will be obtained in accordance with the 
laboratory manual from each patient at the time point specified in Table 11-1 or when immune-
related AEs occur. All samples should be collected as close as possible to the scheduled time 
point. The actual sampling date and time will be recorded in both the eCRF and source 
documents. 
6.5.3 Safety Blood Sampling 
Blood samples for clinical chemistry, hematology test, and serum pregnancy tests will be 
collected for analysis throughout the study at the time points specified in Table 11-1 and Table 
11-2. The actual sampling date will be recorded in both the eCRF and source documents. 

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6.5.4 Safety Urine Sampling 
Urine samples for urinalysis will be collected for analysis at the time points specified in 
Table 11-1. The actual sampling date will be recorded in both the eCRF and source documents. 
6.5.5 Virology Sampling 
Virology samples of nasopharyngeal swab will be collected for analysis at the time points 
specified in Table 6-2, Table 11-1 and Table 11-2. 
6.6 Labeling, Storage, and Transportation of Samples 
6.6.1 Sample Labeling 
Each sample tube will be clearly labeled with the following information: study number, patient 
number, tube identification and scheduled sampling time point. 
6.6.2 Sample Storage and Shipment 
During the study, blood samples for PK, immunogenicity, and safety analyses and virology 
samples will be collected. 
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 will be retained at the central 
laboratory 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 sample will be stored at the 
Sponsor or a designated biobank for a further 5 years (from the date the sample is transferred to 
the Sponsor/biobank) unless a specific authorization is given by the Sponsor to destroy the 
sample. Additional tests can be conducted at the Sponsor or the biobank if it is required from a 
regulatory or medical perspective. Procedures for storage and shipment will be followed 
according to the laboratory manual. Virology samples will be secured at the central laboratory 
for analysis and backup samples will be retained. The samples can be destroyed by a specific 
authorization of the Sponsor. 
 

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7 Statistical Analysis 
The statistical analysis will be performed using Statistical Analysis System Software Version 
9.4 or higher (SAS institute Inc., Cary, North Carolina, US). The statistical methods for this 
study will be described in a detailed SAP. 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 CSRs. 
Full details of the statistical methods will be described in the SAP. 
7.1 Sample Size Calculation 
The total sample size of 18 patients is not based on a formal statistical hypothesis. A sample 
size justification based on statistical hypotheses is not relevant in this study. The proposed 
number of 6 patients (5 patients for CT-P59 and 1 patient for placebo) in each cohort is set 
empirically based on sample sizes in other Phase 1 studies investigating the safety and 
tolerability of their study drugs and is considered to be sufficient to achieve the objectives of 
the study. 
7.2 Analysis Sets 
The following analysis sets will be used in the statistical analyses. 
Intent-to-treat (ITT) Set: The ITT Set is defined as all randomly assigned patients to study 
drug. 
Safety Set: The Safety Set will include all randomized patients who received a full or partial 
dose of the study drug. 
Pharmacokinetic Set: The PK Set will include all patients in the Safety Set who received a full 
dose of CT-P59 and provide at least 1 evaluable post-treatment PK concentration result. 
7.3 Description of Subgroups to be analyzed 
Subgroup analysis can be implemented to reflect medical, regulatory, or ethnic consideration, 
if required. 

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7.4 Statistical Analysis Methodology 
7.4.1 General Consideration 
Continuous variables will be summarized by reporting the following descriptive statistics: the 
number of observations (n), mean, standard deviation (SD), median, minimum, and maximum. 
Categorical variables will be summarized using frequency tables showing the number and 
percentage of patients within a particular category. Data will be listed in data listings. 
7.4.2 Study Population 
7.4.2.1 Disposition of Patients 
The number and percentage of patients entering and completing the clinical study will be 
presented by the cohort of CT-P59 groups and pooling of placebo group. 
The number of patients who enroll in the study and the number and percentage of patients who 
complete the study will be presented. Frequency and percentage of patients who is withdrawn 
or discontinue from the study, and the reason for withdrawal or discontinuation, will also be 
summarized. 
7.4.3 Safety Analysis 
Safety analyses will be performed in the Safety Set, unless otherwise indicated. 
7.4.3.1 Demographic, Baseline, and Background Characteristics 
Baseline demographic and background variables will be summarized by the cohort of CT-P59 
groups and pooling of placebo group using the ITT Set. 
Demographics (including age, sex, 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. 
7.4.3.2 Adverse Events 
Adverse events will be recorded according to the CTCAE Version 5.0 and will be coded to 
system organ class and preferred term according to Medical Dictionary for Regulatory Activities. 
A TEAE is defined as described in Section 6.1.1.1. The following AE summaries will be 
reported by system organ class, preferred term, and the cohort of CT-P59 groups and pooling of 
placebo group, as appropriate: 

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 
Number and percentage of patients reporting at least 1 TEAE 
 
Number and percentage of patients reporting at least 1 TESAE 
 
Number and percentage of patients discontinuing the study drug due to a TEAE 
 
Number and percentage of patients with TEAESIs (infusion related reaction including 
hypersensitivity/anaphylaxis reaction) 
If more than 1 AE is recorded for a patient within any system organ class or preferred term, the 
patient will be counted only once within the respective summary. Adverse events will also be 
summarized by maximum intensity and relationship to study drug with the percentage of 
patients in each category. All AE data will be presented in the data listings, and additional TEAE 
analyses may be performed as detailed in the SAP. 
7.4.3.3 Clinical Laboratory and Pregnancy Test 
Actual values and changes from baseline for numeric clinical laboratory test (clinical chemistry, 
hematology and urinalysis) results will be summarized by the cohort of CT-P59 groups and 
pooling of placebo group at each scheduled visit using descriptive statistics. Shift tables will be 
generated for categorical clinical laboratory test results. 
Individual clinical laboratory and pregnancy tests results will be presented in data listings. 
7.4.3.4 Electrocardiogram, Physical Examination, and Vital Signs 
Actual values and change from baseline for vital sign measurements will be summarized by the 
cohort of CT-P59 groups and pooling of placebo group at each scheduled visit using descriptive 
statistics. 
Shift tables comparing the categorical Investigator interpretation of 12-lead ECGs and physical 
examinations at each scheduled visit with those at baseline will be summarized by the cohort of 
CT-P59 groups and pooling of placebo group. 
Individual ECG results and the Investigator’s interpretation, physical examination findings, and 
vital sign measurements (including hypersensitivity monitoring) will be presented in data 
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7.4.3.5 Prior and Concomitant Medications 
Prior and concomitant medications will be coded using the WHO Drug Dictionary. All prior and 
concomitant medications data will be listed and summarized by the cohort of CT-P59 groups 
and pooling of placebo group. 
7.4.3.6 Immunogenicity 
Immunogenicity test results will be summarized by the cohort of CT-P59 groups and pooling of 
placebo group at each scheduled visit and presented in a data listing. 
7.4.3.7 SARS-CoV-2 Infection Related Signs and Symptoms 
The assessment results of SARS-CoV-2 infection related signs and symptoms at each scheduled 
visit with those at baseline will be summarized by scheduled visit, and by the cohort of CT-P59 
groups and pooling of placebo group. 
7.4.3.8 Potential Effects on the Incidence of Antibody-dependent 
Enhancement 
The number and percentage of patients with suspicious ADE will be presented by the cohort of 
CT-P59 groups and pooling of placebo group.  
7.4.4 Virology Analysis 
The viral efficacy (viral shedding based on qPCR and cell culture) and characterization of 
SARS-CoV-2 viral isolate (genotyping) will be analyzed on the ITT set. Actual values and 
change from baseline for viral shedding, percentage of patients with positive/negative viral 
shedding, duration (in days) of viral shedding, and AUC of viral levels will be summarized by 
the cohort of CT-P59 groups and pooling of placebo group at each scheduled visit using 
descriptive statistics or frequency tables. Mean viral load titer (log values) for each scheduled 
time point will be plotted. Genotype results will be presented in data listing by the cohort of CT-
P59 groups and pooling of placebo group. 
7.4.5 Efficacy Analysis 
The secondary efficacy endpoints will be analyzed on ITT set and will be summarized by the 
cohort of CT-P59 groups and pooling of placebo group using descriptive statistics or frequency 
tables. 

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7.4.6 Pharmacokinetic Analysis 
All PK analyses will be conducted in the PK Set. The PK parameters of CT-P59 will be analyzed 
using noncompartmental methods based on the actual sampling time points. All parameters will 
be calculated using Phoenix WinNonlin (Pharsight, St Louis, Missouri, USA). 
Pharmacokinetic parameters of AUC0-inf, AUC0-inf /Dose, AUC0-last, AUC0-last/Dose, Cmax, Cmax 
/Dose, Tmax, t1/2, %AUCext, λz, CL, and Vz will be presented in data listings and summarized by 
the cohort of CT-P59 groups at each scheduled visit using descriptive statistics. 
Serum concentration data will be presented in data listings and summarized by the cohort of 
CT-P59 groups at each scheduled visit using descriptive statistics. 
7.5 Interim Analysis 
No formal interim analysis will be performed in this study. The Sponsor plans to prepare two 
CSRs (Section 9.7). 
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 GCP 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 center, review of protocol procedures with the Investigator 
and associated staff prior to the study, periodic monitoring visits by the Sponsor or its designee, 
and direct transmission of clinical laboratory data from central and/or local laboratories into the 
clinical database. The data will be collected via Electronic Data Capture (EDC) using eCRFs. 
The study center will be responsible for data entry into the EDC system. The eCRF will be 
reviewed for accuracy and completeness by the monitor during on-site monitoring visits and 
after their return to the Sponsor or its designee. In the event of discrepant data, the Sponsor will 
request data clarification from the study center, which the study center will resolve 
electronically in the EDC system. The Sponsor will be responsible for the data management of 
this study, including quality checking of the data. 
Central laboratory data will be sent directly to the Sponsor using their standard procedures to 
handle and process the electronic transfer of these data. Quality assurance staff from the Sponsor 
or its designee may visit the study center to carry out an audit of the study in compliance with 

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regulatory guidelines and company policy. Such audits will require access to all study records, 
including source documents, for inspection and comparison with the eCRF. Patient 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 the Sponsor 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 changed based on industry and government SOPs, working practice 
documents, or guidelines. Changes will be reported to the IEC but will not result in a protocol 
amendment. 
8.1 Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain patient confidentiality. All records will be kept in a secure storage 
area with limited access. Clinical information will not be disclosed without the written 
permission of the patient (or the patient’s legal guardian), except as necessary for monitoring 
and auditing by the Sponsor, its designee, the regulatory authorities or the IEC. 
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 Independent Ethics Committee 
Regulations and ICH guidelines require that approval be obtained from an IEC before 
participation of human patients in research studies. Before study onset; the protocol, informed 
consent, advertisements to be used for the recruitment of study patients, and any other written 
information regarding this study to be provided to the patient or the patient’s legal guardian, 
must be approved by the IEC. Documentation of all IEC approvals and of the IEC compliance 
with ICH harmonised tripartite guideline E6(R2): GCP will be maintained by the study center 
and will be available for review by the Sponsor or its designee. 
All IEC approvals should be signed by the IEC chairman or designee and must identify the IEC 
name and address, the clinical protocol by title or protocol number or both, and the data 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 IEC. The Investigator 
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with written reports on any changes significantly affecting the conduct of the study or increasing 
risk to patients. 
8.3 Patient Information and Consent 
A written informed consent in compliance with ICH E6(R2) guidelines will be obtained from 
each patient before entering the study or performing any unusual or nonroutine procedure that 
involves risk to the patient. An informed consent template may be provided by the Sponsor to 
the study center. If any institution-specific modifications to study-related procedures are 
proposed or made by the study center, the consent should be reviewed by the Sponsor or its 
designee or both before IEC submission. Once reviewed, the consent will be submitted by the 
Investigator to his or her IEC for review and approval before the start of the study. If the ICF is 
revised during the course of the study, all active participating patients must sign the revised 
form in case new information becomes available that may be relevant to the patient’s 
willingness to continue participation in the clinical study. 
Before recruitment and enrollment, each prospective patient/legal guardian will be given a full 
explanation of the study and be allowed to read the approved ICF. Once the Investigator is 
assured that the patient/legal guardian understands the implications of participating in the study, 
the patient/legal guardian will be asked to give consent to participate in the study by signing the 
ICF. 
In addition to the standard requirements that physicians are currently obliged to observe when 
providing information, the following points must also be covered: 
 
A description of the objectives of the study and how it will be organized 
 
The type of treatment 
 
Any potential negative effects attributable to the study drug 
 
The freedom to ask for further information at any time 
 
The patient’s right to withdraw from the clinical study at any time without giving reason 
and without jeopardizing the patient’s further course of medical treatment 
 
The existence of patient insurance coverage and a summary of what is included in this 
coverage 
 
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The Investigator will be supplied with an adequate number of ICFs to be used. The forms will 
be signed and dated by both the Investigator or Sub-Investigator and the patient’s legal 
representatives (according to the local regulations) before the beginning of the study. The 
Investigator shall retain the signed original ICF(s) and give a copy of the signed original form 
to the patient or legal guardian. 
To ensure medical confidentiality and data protection, the signed ICFs will be stored in the 
Investigator’s study file. The Investigator will allow inspection of the forms by authorized 
representatives of the Sponsor, IEC members, and regulatory authorities. The Investigator will 
confirm, by signing and dating the eCRFs, that informed consent has been obtained. 
8.4 Study Reporting Requirements 
By participating in this study, the Principal Investigator or Sub-Investigator agrees to submit 
reports of SAEs according to the timeline and method outlined in Section 6.1.1.1.7. In addition, 
the Principal Investigator or Sub-Investigator agrees to submit annual report to his or her IEC 
as appropriate. 
8.5 Financial Disclosure and Obligations 
CELLTRION, Inc. is the Sponsor of the study and is funding the study. All financial details are 
provided in the separate contracts between the institution, Investigator, and CRO. The Sponsor 
maintains appropriate insurance coverage for clinical studies and will follow applicable local 
compensation laws. The Sponsor will indemnify all Investigators participating in this study 
against future claims by study patients; the terms of this will be detailed within a separate letter 
of indemnification. The indemnity will only apply where all study procedures have been carried 
out according to this protocol. 
The Investigator is required to take out liability insurance for all patients included in the study 
as required by local law and/or regulations and/or ICH GCP, whichever is applicable. 
The Investigator and the Sponsor will sign a clinical study agreement before the start of the 
study. The agreement will outline overall Sponsor and Investigator responsibilities in relation 
to the study. Financial remuneration will cover the costs based on the calculated expenses of 
performing the study assessments in accordance with the protocol and the specified terms of 
payment will be described in the contract. 
Investigators are required to provide financial disclosure information to allow the Sponsor to 
submit the complete and accurate certification or disclosure statements per regional 

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requirements. 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 its designee is financially responsible for further testing or treatment or 
any medical condition that may be detected during the Screening process. In addition, in the 
absence of specific arrangements, neither the Sponsor nor its designee is financially responsible 
for further treatment of the patient’s pre-existing disease prior to study participation (Screening). 
The Sponsor undertakes to compensate the patient for injuries which are considered, on the 
balance of probabilities, to have arisen as a result of their participation in the trial. 
8.6 Investigator Documentation 
Before beginning the study, the Investigator will be asked to comply with ICH E6(R2) 8.2 and 
Title 21 of the Code of Federal Regulations by providing the following essential documents, 
including but not limited to: 
 
Independent Ethics Committee approval 
 
Original Investigator-signed Investigator agreement page of the protocol 
 
Curriculum vitae for the Principal Investigator and each Sub-Investigator. Current licensure 
must be noted in the curriculum vitae. The curriculum vitae will be signed and dated by the 
Principal Investigators and Sub-Investigators at the 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. 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 
 
Independent Ethics Committee-approved informed consent, samples of study center 
advertisements for recruitment for this study, and any other written information regarding 
this study that is to be provided to the patient or legal guardian, and 
 
Laboratory certifications and normal ranges for any local laboratories used by the study 
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8.7 Study Conduct 
The Investigator agrees that the study will be conducted according to Declaration of Helsinki, 
the principles of ICH E6(R2) and all applicable regulations. The Investigator will conduct all 
aspects of this study in accordance with all national, state, and local laws or regulations. 
8.8 Data Collection 
8.8.1 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 patients 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 patient data into the eCRF as accurately 
as possible, and respond to any reported discrepancies rapidly. 
The eCRFs are accessed through the appropriate system, which allows for on-site data entry 
and data management. Study center users will have access to read and write in the Sponsor’s 
database 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 account 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. 
8.9 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. 
8.10 Investigator’s Final Report 
Upon completion of the study, the Investigator, where applicable, should inform the institution; 
the Investigator/institution should provide IEC with a summary of the study’s outcome and the 
Sponsor and regulatory authority(ies) with any reports required. 

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8.11 Record Retention 
Correspondence (e.g., with Sponsor, IEC, or clinical research associates) relating to this clinical 
study will be kept in appropriate file folders. Records of patients, source documents, eCRFs, 
and drug inventory sheets pertaining to the study must be kept on file. 
Essential documents should be retained until at least 15 years after completion or 
discontinuation of the trial or at least 2 years after the granting of the last marketing 
authorization in the EU (when there are no pending or contemplated marketing applications in 
the EU) or for at least 2 years after formal discontinuation of clinical development of the 
investigational product, whichever is the longest. 
These documents can be retained for a longer period, if required by the applicable regulatory 
requirements or by an agreement with the Sponsor. It is the responsibility of the Sponsor 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 must be made to and agreed upon by the Sponsor. 
8.12 Patient Identification Register 
The Investigator agrees to complete a patient 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 patients by assigned number only. 
8.13 Publications 
After completion of the study, the data will be reported at a peer-reviewed scientific journal for 
publication. The Sponsor will be responsible for these activities and will work with the Principal 
Investigator and Sub-Investigator to determine how the manuscript is written and edited, the 
number and order of authors, the publication to which it will be submitted, and 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 prior authorization from 
the Sponsor, but data publication thereof will not be unduly withheld. 

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9 Study Management 
9.1 Sponsor 
CELLTRION, Inc. 
23, Academy-ro, Yeonsu-gu, Incheon 
22014, Republic of Korea 
Phone: +82 32 850 5000 
Fax: +82 32 850 5050 
Email: contact@celltrion.com 
Sponsor Representative 
Sung Hyun Kim 
Head of Clinical Planning Department 
 
 
 
9.2 Vendor Contact 
CRO 
IQVIA Limited 
Green Park 3 Forbury Place 
23 Forbury road, Reading Berkshire 
RG1 3JH United Kingdom 
SAE Reporting 
IQVIA Lifecycle Safety 
 
9.3 Central Analytical Facility 
Analyses of PK, virology and immunogenicity samples will be performed in following central 
analytical facility: 
PPD Bioanalytical Lab  
2244 Dabney Road Richmond,  
VA 23230-3323 United States  
Phone: +1 804 359 1900 

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Viroclinics Bioscience BV 
Rotterdam Science Tower, Marconistraat 16, 
3029 AK Rotterdam, The Netherlands 
Phone: +31 88 668 4787 
 
The information of other facilities not listed above will be provided in the Laboratory Manual. 
Analytical facility and any procedures utilized for this study must be Good Laboratory Practice 
compliant. 
9.4 Monitoring 
9.4.1 Dose Escalation Committee 
The DEC is consist of Investigator, representatives of the Sponsor, and medical monitor of CRO. 
The DEC will be appointed for safety oversight and will make decision on continuation of next 
group dosing or dose escalation according to the criteria specified in Section 3.3. 
Further details will be provided in DEC charter. 
9.4.2 Data and Safety Monitoring Board 
This study will be monitored by an independent DSMB consisting of a PK specialist, statistician, 
chairing physician, and an independent physician. 
The appointed DSMB members will review the safety data and make a decision on continuation 
the study according to the criteria specified in Section 3.3. The DSMB will also review the data 
up to Day 14 of the last patient to evaluate preliminary safety and make recommendations on 
conduct of the study. 
Further details will be provided in the independent DSMB charter. 
9.4.3 Monitoring of the Study 
The clinical monitor, as a representative of the Sponsor, has the obligation 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 letter 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. 
In case where a monitoring visit cannot be made because of SARS-CoV-2 pandemic situation, 
the monitor will discuss with the Sponsor, CRO, and the Investigator for further plan. 

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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) and 
SOPs. 
9.4.4 Inspection of Records 
Investigators and institutions involved in the study will permit study-related monitoring, audits, 
IEC 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, representatives of the Sponsor, 
or a regulatory agency to access to all study records. 
The Investigator should promptly notify the Sponsor and CRO of any audits scheduled by any 
regulatory authorities. 
9.5 Management of Protocol Amendments and Deviations 
9.5.1 Modification of the Protocol 
Any changes in this research activity, except those necessary to remove an apparent, immediate 
hazard to the patient, must be reviewed and approved by the Sponsor or its designee. Substantial 
amendments to the protocol must be submitted in writing to the applicable IEC and Regulatory 
Authority for approval before patients are enrolled under an amended protocol. This will be 
fully documented. 
The Investigator must not implement any deviation from or change to the protocol without 
discussion and agreement from the Sponsor or its designee, and prior review, documented 
approval, and favorable opinion of the amendment from the relevant IEC and/or regulatory 
authorities, except where it is necessary to eliminate an immediate hazard to patients or where 
the changes involve only logistical or administrative aspects of the clinical study. The eCRF and 
source documents will describe any departure from the protocol and the circumstances requiring 
it. 
Protocol amendments will be submitted to the appropriate authorities as required by the 
applicable regulatory requirements. 
9.5.2 Protocol Deviations 
The Investigator or designee must document and explain in the patient’s source documentation 
any deviation from the approved protocol. The Investigator may implement a deviation from, 
or a change of, the protocol to eliminate an immediate hazard to study patients without prior 

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IEC approval. As soon as possible after such an occurrence, the implemented deviation or 
change, the reasons for it, and any proposed protocol amendments should be submitted to the 
IEC 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 IEC and agreed to by the Investigator. A 
significant deviation occurs when there is nonadherence to the protocol by the patient or 
Investigator that results in a significant and additional risk to the patient’s right, safety and 
well-being. Significant deviations may include nonadherence to inclusion or exclusion criteria, 
or nonadherence to regulations or ICH GCP guidelines. 
Protocol deviations will be documented by the clinical monitor throughout the course of 
monitoring visits. Deviations will be defined before unblinding. Principal Investigator will be 
notified in writing by the monitor of deviations. The IEC will be notified of protocol deviations, 
if applicable, in a timely manner. 
9.6 Study Termination 
Although the Sponsor has every intention of completing the study, the Sponsor reserves the 
right to discontinue the study at any time for clinical or administrative reasons. 
The end of the study is defined as the date of final database lock with no further database change 
for the final CSR. 
9.7 Final Report 
Whether the study is completed or prematurely terminated, the Sponsor will ensure that the 
CSRs are prepared and provided to the regulatory agency(ies) as required by the applicable 
regulatory requirement(s). The Sponsor will also ensure that the CSRs in marketing applications 
meet the standards of the ICH harmonised tripartite guideline E3: Structure and content of CSRs. 
The Sponsor plans to prepare two CSRs to report the following: 
 
First CSR: data up to Day 14 of the last enrolled patient 
 
Final CSR: all data after completion of the study 
If additional CSRs are required for regulatory or academic purposes, CSRs will be generated 
after the first database lock and unblinding process. 

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10 Reference List 
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). 
(2017). Guideline on strategies to identify and mitigate risks for first-in-human and early 
clinical trials with investigational medicinal products. London. EMEA/CHMP/SWP/28367/07 
Rev. 1. Available from: https://www.ema.europa.eu/en/documents/scientific-
guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-
investigational_en.pdf 
Food and Drug Administration. Code of Federal Regulations Title 21 (regulation 21 CFR 
320.38). Available from: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.38 
ICH Assembly. Integrated Addendum to ICH E6(R2): Guideline for good clinical practice 
E6(R2): ICH harmonised guideline. International Council for Harmonisation. 09 November 
2016. 
National Institute of Allergy and Infectious Diseases. Adaptive platform treatment trial for 
outpatients with COVID-19. 31 May 2020. 
Tang X, Wu C, Li X, et al. On the origin and continuing evolution of SARS-CoV-2. National 
Science Review. 2020;0:1-12. 
US Department of Health and Human Services. (2010). National Institutes of Health, National 
Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 
Available from: http://evs.nci.nih.gov/ftp1/CTCAE/About.html 
Varga Z, Flammer AJ, Steiger P, et al. Endothelial cell infection and endotheliitis in COVID-
19. Lancet. 2020 May 2;395:1417-18. 
World Health Organization. Coronavirus disease (COVID-19) Situation Report-135. 03 June 
2020. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-
2019/situation-reports/ 
World Health Organization. Disease outbreak news. 05 January 2020. Available from: 
http://who.int/csr/don/05-january-2020-pneumonia-of-unkown-cause-china/en/ 
World Health Organization Guidelines. Infection prevention and control of epidemic- and 
pandemic-prone acute respiratory infections in health care. Available from: 
https://www.who.int/csr/bioriskreduction/infection_control/publication/en/ 

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11 Appendices 
11.1 Schedule of Assessments 
Table 11-1 Schedule of Assessments 
Study Day (Visit windows) 
Screening 1 
Treatment Period 
EOT 2 
Follow-Up 
Period 3 
-7 to 1 
1 
2 
3 
4 
5 
6 
7 
10 
14 (±1) 21 (±1) 28 (±3) 56 (±5) 90 (±5) 
Bi-weekly 
up to 180 (±5) 
In-house Stay 4 
 
X 
X 
X 
(X) 
(X) 
(X) 
(X) 
 
 
 
 
 
 
 
Telephone Follow-Up Visit 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 5 
X 
X 6 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight, BMI and height 7 
X 
X 6 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Physical Examination 
X 
X 6 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Urine drug abuse check 8 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hepatitis B/C and HIV test 9 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Serum pregnancy test 10 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Clinical laboratory analyses 11 
X 
X 6 
X 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
 
Vital Signs (blood pressure, heart rate, 
respiratory rate, SpO2 and body 
temperature) 12 
X 
X 6 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
12-lead ECG 13 
X 
X 6 
X 
 
 
 
 
X 
 
X 
 
X 
X 
X 
 
Radiography 14 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Randomization 
X 6 
 
 
 
 
 
 
 
 
 
 
 
 
 
Administration of study drug 15 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nasopharyngeal swab 16 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
RT-PCR (local) 17 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
Viral shedding (central, qPCR 
and Cell culture) 
 
X 6 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 

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Study Day (Visit windows) 
Screening 1 
Treatment Period 
EOT 2 
Follow-Up 
Period 3 
-7 to 1 
1 
2 
3 
4 
5 
6 
7 
10 
14 (±1) 21 (±1) 28 (±3) 56 (±5) 90 (±5) 
Bi-weekly 
up to 180 (±5) 
In-house Stay 4 
 
X 
X 
X 
(X) 
(X) 
(X) 
(X) 
 
 
 
 
 
 
 
Telephone Follow-Up Visit 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
• 
Genotyping of SARS-CoV-2 
viral isolates (central) 
 
X 6 
(X) 18 
 
 
 
Patient diary for SARS-CoV-2 Infection 
Symptom Checklist 19 
X 
X 
(X) 
(X) 
 
SARS-CoV-2 infection related signs 
and symptoms assessment 20 
X 
X 6 
X 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
X 
Pharmacokinetic sampling 21 
 
X 
X 
X 
 
X 
 
X 
X 
X 
 
X 
X 
X 
 
Immunogenicity sampling 
 
X 6 
 
 
 
 
 
X 
 
X 
 
X 
X 
X 
 
Hypersensitivity monitoring 22 
 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Disease status monitoring 23 
X 
 
Restriction assessment 
X 
 
Prior, concomitant medication 24 
X 
 
Adverse events 25 
X 
 
Abbreviations: ADE=antibody-dependent enhancement; AE=adverse event; ALT=alanine aminotransferase; AST=aspartate aminotransferase;  BMI=body mass index; CRP=C-
reactive protein; CT=computed tomography; ECG=electrocardiogram; EOT=End-of-Treatment; ESR=erythrocyte sedimentation rate; HBcAb=hepatitis B core antibody, 
HBsAg=hepatitis B surface antigen; HIV=human immunodeficiency virus; ICF=informed consent form; PK=pharmacokinetic; qPCR= quantitative polymerase chain reaction; RT-
PCR=reverse-transcription polymerase chain reaction; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SpO2= peripheral capillary oxygen saturation 
1. If Screening visit date and the administration of study drug date (Day 1) are same, all assessments scheduled for the Screening and Day 1 visit can be performed only once on 
the date before randomization. 
2. End-of-Treatment visit assessments will be performed on Day 90. If a patient is early terminated from the study, the patient will be asked to return to the study site for the 
safety assessments predefined on an EOT visit. If deemed necessary by the investigator, then the patient will be asked to return at the scheduled EOT visit.  
3. For all patients, (including a patient who early terminated from the study, if possible) each telephone call follow-up will occur bi-weekly from 2 weeks after the EOT visit to 
Day 180. During the Follow-Up Period, SARS-CoV-2 infection related signs and symptoms will be assessed by telephone call to capture the suspicious ADE occurrence. For 
patients with suspicious ADE occurrence, all assessments specified in Table 11-2 will be conducted on unscheduled visit. 
4. All patients will be admitted to the study center on Day 1 and it is recommended to be confined up to Day 7. In-house stay period can be determined by investigator considering 
the isolation regulation and/or public health capacity of the country, however all patients should be confined to the study center for at least 72 hours (until completion of all 
assessments on Day 3). After discharge, the consecutive study visits will be carried out on an out-patient basis. During the isolation period according to the regulatory of the 
country, patients will visit the study center using the transportation provided by Sponsor. 
5. Inclusion and exclusion criteria will be confirmed at Screening and on Day 1. If it is concluded that the patients are not eligible in Day 1 assessments, the patients will be 
considered as Screening failure even if he/she was eligible based on assessments results performed during Screening Period.  

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6. These assessments should be performed prior to the study drug administration. 
7. Measurement of height and BMI will be performed once at Screening. 
8. A urine drug tests will be performed at Screening. The screen for drug abuse includes methamphetamine, barbiturates, benzodiazepines, cocaine, tetrahydrocannabinol, and 
opiates. The urine test can be repeated once at the discretion of the Investigator. 
9. At Screening, HBsAg, HBcAb, hepatitis C antibody, HIV-1 or -2 test must be assessed in all patients (mandatory). If HBsAg test result is positive, the patient cannot be enrolled 
in the study. If HBcAb test is positive, the patient also cannot be enrolled. If hepatitis C antibody, HIV-1 or -2 test result is positive, the patient must be excluded from the 
study. 
10. 
For female patients with childbearing potential, serum pregnancy test will be performed at Screening and EOT visit. If serum pregnancy test is unavailable, urine pregnancy 
test can be performed instead. Only patients who are confirmed as nonpregnant can be enrolled in the study. 
11. Clinical laboratory testing (clinical chemistry, hematology, and urinalysis) will be performed.  
Clinical chemistry 
Total protein, serum bilirubin (total, direct), ALT, AST, alkaline phosphatase, γ-glutamyl transferase, blood urea nitrogen, creatinine, creatine 
kinase, creatine kinase-myocardial band isoenzyme, troponin (I or T, only one applicable), albumin, sodium, potassium, calcium, chloride, 
inorganic phosphorus, glucose, lactate dehydrogenase, total cholesterol, triglyceride, high-density lipoprotein cholesterol, and CRP 
Hematology 
Red blood cells, ESR, total white blood cell count, absolute neutrophil count, eosinophil count, lymphocyte count, platelet count, hemoglobin, 
mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, and hematocrit 
Urinalysis 
Bilirubin, blood, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, and microscopic examination of white blood 
cell count, red blood cell count, and bacteria 
12. Blood pressure, heart rate, respiratory rate, SpO2 and body temperature will be measured after the patient has rested quietly for at least 5 minutes. SpO2 will be measured while 
breathing normal room air. Temperature will be measured using tympanic thermometer throughout the study. 
13. All scheduled 12-lead ECGs must be performed after the patient has rested quietly for at least 5 minutes. Regardless of the 12-lead ECG result, further cardiological evaluation 
can be performed at the Investigator’s discretion. 
14. Radiography (chest x-ray and/or chest CT) will be performed at the scheduled time point and when the investigator considers it is clinically necessary (e.g., abnormal findings 
of SpO2). 
15. Study drug will be administered as an IV infusion for 90 minutes (±15 minutes) on Day 1. When calculating total volume of study drug to be administered, the body weight of 
each patient measured on Day 1 will be used. 
16. Nasopharyngeal swabbing will be performed by trained site personnel. A nasopharyngeal swab sampling time points and acceptable tolerance windows are specified in Table 
6-2 and below: 
• 
Screening: If Screening and administration of study drug occur on the same day, sampling of nasopharyngeal swab will be performed twice both for RT-PCR (local) of 
Screening and viral shedding and genotype (central) of Day 1, respectively. 
• 
Day 1: predose (within the day) 
• 
Day 2: 24 hours (±4 hours) after the start of the study drug infusion. 
• 
Day 3: 48 hours (±4 hours) after the start of the study drug infusion. 
• 
Day 4: 72 hours (±4 hours) after the start of the study drug infusion. 
• 
Day 5: 96 hours (±4 hours) after the start of the study drug infusion. 
• 
Day 6: 120 hours (±4 hours) after the start of the study drug infusion. 
• 
Day 7: 144 hours (±4 hours) after the start of the study drug infusion. 
• 
Day 10: 216 hours (±4 hours) after the start of the study drug infusion. 
• 
Day 21 (±1 day) 
• 
Day 14 (±1 day) 
• 
Day 28 (±3 days) 

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17. If the patient had RT-PCR result confirming SARS-CoV-2 infection prior to obtaining written informed consent (but no more than 7 days from the onset of symptoms), the 
result can be allowed. During the Screening Period, only one retest for RT-PCR will be allowed, if study drug can be administered no more than 7 days from onset of symptom 
based on retest results. 
18. The genotyping will be performed on samples at time point when resistance is suspected, but not limited to. 
19. 
After study drug administration, patients will be instructed to complete the patient diary for SARS-CoV-2 Infection Symptom Checklist twice a day at approximately 12-hour 
intervals in the morning (between 6 and 10 AM, approximately) and in the evening (between 6 and 10 PM, approximately) from Day 1 until clinical recovery or Day 28, 
whichever comes first. The patient diary will be recorded once at Screening. On the date of study drug administration (Day 1), the patient diary will be recorded twice 
before and after the study drug administration. After Day 28, additional recording of the diary will be required if following conditions are met: 
• 
For patients who will achieve clinical recovery at Day 28, patients will record the diary until Day 29 to confirm whether it is maintained at least 24 hours. 
• 
For patients who will show deterioration (at the discretion of the investigator) after the achievement of clinical recovery, patient will record the diary until secondary 
achievement of clinical recovery. 
• 
After Day 28 of regular scheduled study visit, for patients with suspicious ADE occurrence, patient will record the diary for 7 days from the day of suspicious ADE 
occurrence (specified in Table 11-2). 
However, if patient’s condition is not available to record the diary at the discretion of investigator (e.g. sedation state for mechanical ventilator therapy), recording can be 
discontinued. 
20. During the Screening, Treatment Period, and EOT visit, the Investigator or designee will perform a respiratory signs and symptoms assessment (which should include, at a 
minimum, the examination of ear, nose, throat, sinuses, and lungs) and assessment for potential complications of SARS-CoV-2 infection. During the Follow-Up Period, patients 
will be asked if they have any SARS-Cov-2 infection related signs and symptoms by telephone call. 
21. PK analysis will be performed at the central laboratory. Blood sampling time points and acceptable tolerance windows for PK assessments are specified in Table 6-3 and below: 
• 
Day 1: predose (within the day), end of infusion (+15 minutes), and 1 hour (+15 minutes) after the end of infusion. 
• 
Day 2: 24 hours (±1 hour) after start of infusion. 
• 
Day 3: 48 hours (±1 hour) after start of infusion. 
• 
Day 5: 96 hours (±4 hours) after start of infusion. 
• 
Day 7: 144 hours (±4 hours) after start of infusion. 
• 
Day 10: 216 hours (±4 hours) after start of the infusion. 
• 
Day 14 (±1 day), Day 28 (±3 days), Day 56 (±5 days), and Day 90 (±5 days)/EOT visit. 
22. Hypersensitivity monitoring will be performed at Day 1 predose (within 30 minutes), 15 minutes (±5 minutes), 30 minutes (±5 minutes), 60 minutes (±5 minutes), 90 minutes 
(±5 minutes), 2 hours (±15 minutes), 3 hours (±15 minutes), 6 hours (±15 minutes), 12 hours (±15 minutes), 24 hours (±30 minutes) from the start of infusion (specified in 
Table 6-1). Vital signs including blood pressure, heart rate, respiratory rate and body temperature will be evaluated for possible hypersensitivity reactions. Any type of ECG 
will be performed if a patient experiences cardiac symptoms. Emergency equipment, such as adrenaline, antihistamines, corticosteroids, and respiratory support (inhalational 
therapy, oxygen and artificial ventilator) must be available. 
23. Disease status including requirement of supplemental oxygen, intensive care unit transfer, mechanical ventilation use, hospitalization will be monitored during the study period 
(from signing of ICF to EOT). 
24. Prior and/or concomitant medication use will be recorded for the 30 days before the signed date of ICF until the EOT visit.  
25. Adverse events will be assessed from the date the ICF is signed until up to EOT visit, regardless of the relationship to the study drug. All incidences of ADE occurring during 
the follow-up period will be reported as an AE, irrespective of causal relationship. 
 
 

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Table 11-2 Schedule of Assessments for Patients with Suspicious ADE Occurrence (Unscheduled Visits) 
Evaluation 
Suspicious ADE Assessment 
Day of occurrence 1 
Day 2 
Day 3 
Day 5 
Day 7 2 
Nasopharyngeal swab 
 
 
 
 
 
• 
RT-PCR (local) 3 
(X) 
• 
Viral shedding (central, qPCR and Cell culture) 
X 
X 
X 
X 
X 
• 
Genotyping of SARS-CoV-2 viral isolates (central) 4 
(X) 
Patient diary for SARS-CoV-2 Infection Symptom Checklist 5 
X 
SARS-CoV-2 infection related signs & symptoms assessment 6 
X 
X 
X 
X 
X 
Vital Signs 7 
X 
X 
X 
X 
X 
12-lead ECG 8 
X 
 
X 
 
X 
Troponin test (I or T, only one applicable) 
X 
 
X 
 
X 
Abbreviations: ADE=antibody-dependent enhancement; ECG=electrocardiogram; qPCR= quantitative polymerase chain reaction; RT-PCR= reverse-transcription polymerase chain 
reaction; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SpO2= peripheral capillary oxygen saturation 
Note: For suspicious ADE assessment, patients can be hospitalized based on the investigator’s decision. If required, additional assessments can be performed by investigator’s 
discretion during the hospitalization period. Otherwise, the assessment will be done by out-patient visit. The genotype assessment marked as (X) will be performed in selected 
visits under the conditions explained in the relevant document of virology analysis. 
1. 
The day of suspicious ADE occurrence. 
• 
If a patient has excessive progression of symptoms regarded as related to viral infection (e.g., excessive infiltration of inflammatory cells in the lung), OR 
• 
If a patient has other SARS-CoV-2 infection related signs and symptoms which are judged as possible manifestations of ADE according to the medical opinion of the 
Investigator. 
2. 
If symptoms have not resolved or have worsened up to Day 7 after the day of suspicious ADE occurrence, same procedure will repeat until when the symptoms are resolved 
and/or no SARS-CoV-2 infection is confirmed by RT-PCR (local). 
3. 
If required, RT-PCR (local) can be performed at any time by Investigator's discretion.  
4. 
The genotyping will be performed on samples at time point when resistance is suspected, but not limited to. 
5. 
For patients with suspicious ADE occurrence, patient will record the patient diary for SARS-CoV-2 Infection Symptom Checklist for 7 days from the day of suspicious ADE 
occurrence. Patients will be instructed to complete the diary twice a day at approximately 12-hour intervals in the morning (between 6 and 10 AM, approximately) and in the 
evening (between 6 and 10 PM, approximately). 
6. 
The Investigator or designee will perform a respiratory signs and symptoms assessment (which should include, at a minimum, the examination of ear, nose, throat, sinuses, and 
lungs) and assessment for potential complications of SARS-CoV-2 infection. 
7. 
Blood pressure, heart rate, respiratory rate, SpO2 and body temperature will be measured after the patient has rested quietly for at least 5 minutes. SpO2 will be measured while 
breathing normal room air. Temperature will be measured using tympanic thermometer throughout the study. 
8. 
All scheduled 12-lead ECGs must be performed after the patient has rested quietly for at least 5 minutes. Regardless of the 12-lead ECG result, further cardiological evaluation 
can be performed at the Investigator’s discretion.  
 

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11.2 SARS-CoV-2 Infection SYMPTOM CHECKLIST 
All patients will complete the checklist twice a day at approximately 12-hour intervals in the 
morning (between 6 and 10 AM) and in the evening (between 6 and 10 PM) from Day 1 until 
clinical recovery or Day 28, whichever comes first.  
After Day 28, additional recording of the diary will be required if following conditions are met 
(specified in Section 6.3.1): 
 
For patients who will achieve clinical recovery at Day 28, patients will record the diary 
until Day 29 to confirm whether it is maintained at least 24 hours. 
 
For patients who will show deterioration (at the discretion of the Investigator) after the 
achievement of clinical recovery, patient will record the diary until secondary achievement 
of clinical recovery. 
 
After Day 28 of regular scheduled study visit, for patients with suspicious ADE occurrence, 
patient will record the diary for 7 days from the day of suspicious ADE occurrence 
(specified in Table 11-2). 
 
Please read the below question and check one box that describes your 
symptoms of the following SARS-CoV-2 infection symptoms. 
 
 
Absent (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
1 
Feeling feverish  
 
 
 
 
2 
Cough 
 
 
 
 
3 
Shortness of breath or 
difficulty breathing  
 
 
 
 
4 
Sore throat 
 
 
 
 
5 
Body pain or muscle pain 
 
 
 
 
6 
Fatigue 
 
 
 
 
7 
Headache 
 
 
 
 
Mild: no interference with normal daily activity 
Moderate: interferes with normal daily activity 
Severe: prevents normal daily activity 
Source: National Institute of Allergy and Infectious Diseases. Adaptive platform treatment trial for outpatients with 
COVID-19. 31 May 2020.