An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Phase: PHASE3
Conditions: Immunologic Deficiency Syndromes
Sponsor: Green Cross Corporation

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
 
Version 2.0 Amendment 3 
 
Page 1 of 75 
 
 
 
 
 
CLINICAL STUDY PROTOCOL 
 
 
Study Title:  An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter 
Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin 
Intravenous (Human) GC5107 in Subjects with Primary Humoral Immunodeficiency 
 
 
SPONSOR: 
Green Cross Corporation 
 
107 (Mogam Building), Ihyeon-ro 
 
30beon-gil, Giheung-gu, Yongin-si, 
 
Gyeonggi-do, Korea 
 
 
PROTOCOL NUMBER: 
GC5107B_P3 
 
 
VERSION 1.0: 
JANUARY 19, 2016 
Date of Amendment 1 
February 19, 2016 
Date of Amendment 2            March 11, 2016 
Date of Amendment 3 
March 24, 2016 
 
VERSION 2.0: 
JUNE 29, 2016 
Date of Amendment 1: 
March 16, 2017 
Date of Amendment 2: 
September 29, 2017 
Date of Amendment 3:  
January 04, 2019 
 
 
Confidentiality Statement: 
 
The information contained in this protocol is provided to you in confidence, for review by you, 
your staff and any applicable regulatory authority or Institutional Review Board/Independent 
Ethics Committee/Research Ethics Board.  It is understood that this information may not be 
disclosed to any other party in any form without prior authorization from the Sponsor, except to 
the extent necessary to obtain informed consent from the subject to whom the drug may be 
administered. 
 
 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 2 of 75 
SYNOPSIS 
 
STUDY TITLE 
An Open-Label, Single-Arm, Historically Controlled, 
Prospective, Multicenter Phase III Study to Evaluate the 
Safety, Efficacy and Pharmacokinetics of Immune 
Globulin Intravenous (Human) GC5107 in Subjects with 
Primary Humoral Immunodeficiency 
SPONSOR 
Green Cross Corporation 
107 (Mogam BLDG), Ihyeon-ro 
30beon-gil, Giheung-gu, Yongin-si, 
Gyeonggi-do, Korea 
INVESTIGATIONAL 
PRODUCT 
Immune globulin intravenous (human) solution, 10% 
liquid, GC5107  
CLINICAL TRIAL DESIGN 
Phase III, open label, single-arm, historically controlled 
prospective, multicenter study 
INDICATION AND 
CLINICAL USE 
Treatment 
of 
subjects 
with 
primary 
humoral 
immunodeficiency (PHID)  
OBJECTIVES 
To assess the safety, efficacy, and pharmacokinetics (PK) 
of GC5107 in subjects with PHID 
INFUSION RATE 
First infusion: 
Initial rate: 1.0 mg/kg/min (0.01 mL/kg/min) for 30 
minutes 
Incremental rate: 
 2.0 mg/kg/min (0.02 mL/kg/min) at 30 minutes 
 4.0 mg/kg/min (0.04 mL/kg/min) at 60 minutes 
 8.0 mg/kg/min (0.08 mL/kg/min) at 90 minutes 
If the first infusion is well tolerated, infusions 2-13(17):  
Initial rate: 2.0 mg/kg/min (0.02 mL/kg/min) for 15 
minutes 
Incremental rate: 
 4.0 mg/kg/min (0.04 mL/kg/min) at 15 minutes 
 8.0 mg/kg/min (0.08 mL/kg/min) at 30 minutes 
Maximum rate: 8.0 mg/kg/min (0.08 mL/kg/min) 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 3 of 75 
STUDY POPULATION 
 Male or female aged 2 to 70 years with PHID requiring 
immune globulin intravenous (IGIV) treatment 
 Total Number of Subjects: Up to 50 subjects will be 
enrolled to obtain at least 42 subjects to be included 
into the study: 
o Adults: at least 26 subjects  
o Adolescents: at least 8 subjects aged ≥ 12 to < 
17 years 
o Children: at least 8 subjects aged ≥ 2 to < 12 years 
 PK population: at least 20 adult and adolescent subjects 
 Subjects already stabilized (trough level of 500 mg/dL) 
on regular IGIV treatment 
DOSAGE REGIMEN 
 All subjects will receive  intravenous infusions of the 
investigational product at the same dose and interval as 
used for their previous IGIV maintenance therapy  
 Dose of 300 – 900 mg/kg (of body weight) every 21 or 
28 days (± 4 days) for 12 months 
TARGET TROUGH LEVEL 
≥ 500 mg/dL (5 g/L) 
STUDY PERIOD 
Approximately 14 months / each subject: 
 Screening: up to 28 days 
 Treatment (investigational product infusions) period: 
12 months 
 Follow-up period: 3 or 4 weeks 
INCLUSION CRITERIA 
1. Subject has a confirmed clinical diagnosis of a PHID 
disease as defined by International Union of 
Immunological Societies (IUIS) and requires treatment 
with IGIV, and has documented agammaglobulinemia 
or hypogammaglobulinemia. 
2. Male or female, aged 2 to 70 years. 
3. The subject has received 300-900 mg/kg of IGIV 
therapy at 21(±4 days) or 28(±4 days)day intervals for 
at least 3  infusion prior to this study. 
4. At least 2 documented IgG trough levels of 
≥ 500 mg/dL are obtained at two infusion cycles 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 4 of 75 
(21(±4 days) or 28(±4 days) days) within 12 months 
prior to study treatment. 
5. Subject is willing to comply with all requirements of 
the protocol. 
6. Females of child-bearing potential with a negative 
pregnancy test at screening and females who agree to 
employ adequate birth control measures during the 
study. 
7. Males who agree to practice adequate birth control 
measures during the study. 
8. Subject, parent or guardian has signed the informed 
consent form and an assent form for children (≥ 2 to 
< 12 years of age at study entry) and adolescents  
( ≥ 12 to < 17 years of age at study entry) as 
appropriate per study documentation and regulations of 
the local jurisdiction. 
9. Authorization to access personal health information. 
10. Subject currently participating in a clinical trial with 
another experimental IGIV may be enrolled if he/she 
has received stable IGIV therapy for at least 3 infusion 
cycles prior to receiving GC5107 and all inclusion and 
exclusion criteria are satisfied. 
 
Other IGIVs will be prohibited for an infusion 
cycle (21(±4 days) or 28(±4 days) days) prior to 
the first infusion of GC5107 until the completion 
of Follow-up visit. 
11. Subject 
currently 
participating 
in 
a 
trial 
of 
subcutaneous immunoglobulin (SCIG) can be enrolled 
if he/she is switched to IGIV for three infusion cycles 
(21(±4 days) or 28(±4 days) days) prior to enrollment 
in this study. 
EXCLUSION CRITERIA 
1. Subject has secondary immunodeficiency. 
2. Subject was newly diagnosed with PHID and has not 
yet been treated with immunoglobulin. 
3. Subject 
has 
been 
diagnosed 
with 
dysgammaglobulinemia or isolated IgG subclass 
deficiency or isolated IgA deficiency with known anti-
IgA antibodies. 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 5 of 75 
4. History of severe reaction or hypersensitivity to IGIV 
or other injectable forms of IgG. 
5. Subject has a lifetime history of at least one thrombotic 
event including deep vein thrombosis, cerebrovascular 
accident, pulmonary embolism, transient ischemic 
attacks, or myocardial infarction. 
6. Subject has received blood products other than human 
albumin or human immunoglobulin within 12 months 
prior to enrollment. 
7. Subject has protein losing enteropathy, nephrotic 
syndrome or lymphangiectasia. 
8. Subject has had clinical signs or symptoms of an acute 
infection within 7 days prior to screening. 
9. Subject has a known history or is positive at enrollment 
for HIV type 1/2 by nucleic acid testing (NAT), 
hepatitis B virus (HBsAg and NAT), hepatitis C virus 
(by NAT), or hepatitis A virus (by NAT). 
10. Subject has levels of alanine aminotransferase (ALT) 
or aspartate aminotransferase (AST) > 2.5 times of the 
upper limit of normal for the laboratory designated for 
the study. 
11. Subject has profound anemia (hemoglobin [Hgb] 
≤ 8 g/dL) 
or 
persistent 
severe 
neutropenia 
(≤ 1000 neutrophils per mm3). 
12. Subject has a severe chronic condition such as renal 
failure (creatinine concentration > 2.0 times the upper 
limit of normal), congestive heart failure (New York 
Heart Association III/IV), cardiomyopathy, cardiac 
arrhythmia associated with thromboembolic events 
(e.g., atrial fibrillation), unstable or advanced ischemic 
heart disease, hyperviscosity, or any other condition 
that the investigator believes is likely to interfere with 
evaluation of the investigational product or with 
satisfactory conduct of the trial. 
13. Subject has a history of a malignant disease, other than 
properly treated carcinoma in situ of the cervix or basal 
cell or squamous cell carcinoma of the skin within 
24 months prior to enrollment. 
14. Subject has history of epilepsy or migraines not 
completely controlled by medication.  

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 6 of 75 
15. Subject is receiving the following medication:  
 
Corticosteroids (oral or parenteral daily dose of 
≥ 0.15 mg/kg/day of prednisone or equivalent). 
 
Other immunosuppressive drugs or chemotherapy. 
16. Females who are pregnant, breast feeding or planning 
a pregnancy during the study. Women who become 
pregnant during the study will be withdrawn from the 
study. Males who do not agree to use contraception 
will not qualify to be enrolled in the study. Males are 
not allowed to donate sperm during the study. 
17. Subject has participated in another clinical study 
within 3 weeks prior to study enrollment. 
EFFICACY ENDPOINT 
1) Primary Efficacy Endpoint: The incidence of acute 
serious bacterial infections meeting Food and Drug 
Administration (FDA) guidance criteria (bacterial 
pneumonia, bacteremia/sepsis, bacterial meningitis, 
visceral abscess, osteomyelitis/septic arthritis). 
2) Secondary Efficacy Endpoints 
 The incidence of infections other than acute serious 
bacterial infections meeting FDA guidance criteria. 
 The 
number 
of 
days 
missed 
from 
work/school/kindergarten/daycare, or days unable to 
perform normal daily activities due to infections. 
 The number of days that the care provider of the 
pediatric subject had to miss work in order to care for 
the child due to infections. 
 The number days of unscheduled physician visits due 
to infections. 
 The number of days of hospitalizations due to 
infections. 
 The number of days of intravenous (IV) therapeutic 
antibiotics. 
 The number of days of oral therapeutic antibiotics. 
 Time to resolution of infections. 
 The incidence of infections other than serious bacterial 
infections by trough IgG levels. 
SAFETY ENDPOINTS 
1) Primary Safety Endpoint: The proportion of 
infusions with temporally associated adverse events 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 7 of 75 
(AEs) that occur during or within 1 hour, 24 hours, and 
72 hours following an infusion of investigational 
product (including AEs that were determined to be 
unrelated to the product). 
2) Secondary Safety Endpoints 
 The overall incidence of all AEs that occur during or 
within 1 hour, 24 hours ,and 72 hours following an 
infusion of investigational product.  
 The frequency of all AEs that occur during the study 
regardless of the investigator’s assessment of their 
relationship to investigational product. 
 The frequency of suspected adverse reactions as 
defined by all AEs either classified by investigator or 
sponsor as at least possibly related to GC5107. 
 Changes in vital signs, physical examinations, and 
laboratory test results. 
 The number and proportion of GC5107 infusions for 
which the infusion rate was decreased due to AEs. 
 The proportion of AEs considered by the investigator 
to be investigational product related. 
 Viral 
safety 
(freedom 
from 
transmission 
of 
blood-borne 
viral 
diseases): 
the 
human 
immunodeficiency virus (HIV) 1&2, hepatitis A virus 
(HAV), hepatitis B virus (HBV), hepatitis C virus 
(HCV), and parvovirus B19. 
PHARMACOKINETIC 
ENDPOINTS 
1) Primary PK Endpoints 
 PK parameters of total IgG (assessed in PK 
population). 
 Trough serum total IgG levels before each infusion of 
GC5107 in all subjects and the interval between 
infusions will be recorded.  
2) Secondary PK Endpoints 
 PK parameters of IgG subclasses (assessed in PK 
population) 
 Trough serum level of IgG subclasses and specific IgG 
antibodies before Infusion 1, 5, 9, 13 (for 28-day 
infusion subject) or Infusion 1, 5, 11, 17 (for 21-day 
infusion subject) 
o anti-Hemophilus influenza type b 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 8 of 75 
o anti-Streptococcus pneumonia serotypes 
o anti-Tetanus toxoid 
o anti-Cytomegalovirus (CMV) 
 Number and proportion of subjects who failed to meet 
the target IgG trough level (500 mg/dL) at any time 
point equal to or subsequent to 5th infusion (estimated 
5 half-lives). 
ANALYTICAL PLAN / 
STATISTICAL METHOD 
Efficacy data will be evaluated by comparing the number 
of acute serious bacterial infections per subject per year 
according to the FDA guideline of an upper one-sided 99% 
confidence limit < 1.0 per subject per year. The primary 
safety endpoint will be analyzed with the objective of 
demonstrating that the percentage of infusions with one or 
more 
infusion-related 
AE 
is 
less 
than 
40%. 
Pharmacokinetic parameters (clearance, mean residence 
time, volume of distribution, and terminal half-life) will be 
estimated 
by 
fitting 
noncompartmental 
analysis 
individually to the data for each subject in the PK 
population, except for the AUC which will be determined 
using a (log-) trapezoidal rule as the area above the 
previous trough level. Pharmacokinetic parameters will be 
derived from serum IgG levels and presented descriptively. 
Trough levels of IgG subclasses will be summarized 
relative to dosing interval. All other data will be reported 
descriptively. 
 
 
 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 10 of 75 
 
 
Table of Contents 
CLINICAL STUDY PROTOCOL ...................................................................................................................... 1 
SYNOPSIS .................................................................................................................................................................. 2 
AUTHORIZATION PAGE ....................................................................................................................................... 9 
TABLE OF CONTENTS ........................................................................................................................................ 10 
LIST OF TABLES ................................................................................................................................................... 13 
LIST OF ABBREVIATIONS ................................................................................................................................. 14 
1. 
INTRODUCTION ................................................................................................................................. 16 
1.1. 
BACKGROUND: PRIMARY HUMORAL IMMUNODEFICIENCY DISEASES ........................................................... 16 
1.2  
NON-CLINICAL DATA ............................................................................................................................................. 16 
1.3 
 BENEFIT/RISK STATEMENT ................................................................................................................................ 17 
1.4 
 RATIONALE ............................................................................................................................................................. 18 
1.5 
 GCP COMPLIANCE ................................................................................................................................................. 19 
1.6 
 STUDY POPULATION .............................................................................................................................................. 19 
2. 
STUDY OBJECTIVE ............................................................................................................................ 19 
2.1. 
PRIMARY EFFICACY ENDPOINT ............................................................................................................................ 19 
2.2. 
SECONDARY EFFICACY ENDPOINTS ..................................................................................................................... 19 
2.3. 
PRIMARY SAFETY ENDPOINT ................................................................................................................................ 20 
2.4. 
SECONDARY SAFETY ENDPOINTS......................................................................................................................... 20 
2.5. 
PRIMARY PHARMACOKINETIC ENDPOINTS ........................................................................................................ 21 
2.6. 
SECONDARY PHARMACOKINETIC ENDPOINTS ................................................................................................... 21 
3. 
INVESTIGATIONAL PLAN ................................................................................................................ 21 
3.1. 
DURATION OF THE STUDY ..................................................................................................................................... 22 
3.2. 
INVESTIGATORS AND STUDY CENTERS ............................................................................................................... 22 
3.3. 
RANDOMIZATION AND STRATIFICATION ............................................................................................................ 22 
3.4. 
BLINDING ................................................................................................................................................................. 22 
4. 
SELECTION OF STUDY POPULATION .......................................................................................... 22 
4.1. 
INCLUSION CRITERIA ............................................................................................................................................. 23 
4.2. 
EXCLUSION CRITERIA ............................................................................................................................................. 24 
4.3. 
WITHDRAWAL OF SUBJECTS ................................................................................................................................. 25 
4.4. 
EARLY DISCONTINUATION OF STUDY .................................................................................................................. 26 
4.5 
 STOPPING RULES ................................................................................................................................................... 27 
5. 
STUDY CONDUCT ............................................................................................................................... 27 
5.1. 
TREATMENT REGIMENS ........................................................................................................................................ 27 
5.2. 
TREATMENT ASSIGNMENT .................................................................................................................................... 27 
5.3. 
SUBJECT IDENTIFICATION ..................................................................................................................................... 27 
5.4. 
PHYSICAL EXAMINATION ....................................................................................................................................... 28 
5.5. 
MEDICAL HISTORY AND DEMOGRAPHY .............................................................................................................. 28 
5.6. 
SUBJECT DIARY ....................................................................................................................................................... 28 
5.7. 
DOSAGE .................................................................................................................................................................... 29 
5.8. 
VISIT SCHEDULE ..................................................................................................................................................... 29 
5.8.1 
Screening: Day -28 or -21 to Day -1 ............................................................................................................ 30 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 11 of 75 
 
5.8.2 
First Infusion (Day 1, Week 0)........................................................................................................................ 31 
5.8.3 
Safety Visit (72 hours after the end of first infusion) .......................................................................... 32 
5.8.4 
Second Infusion (Week 3 of 21-day and Week 4 of 28-day Infusion Schedules) ..................... 33 
5.8.5 Safety Visit (72 hours after the end of second infusion) .......................................................................... 34 
5.8.6 
Third to 17th Infusion (21-day Schedule); 3rd to 13th Infusion (28-day Schedule) .................. 34 
5.8.7 
Additional Tests .................................................................................................................................................... 35 
5.8.8 
PK Analysis: 5th Infusion of All Participating Subjects ........................................................................ 36 
5.8.10 Follow-up ................................................................................................................................................................. 36 
5.8.11 Unscheduled Visit Procedures ........................................................................................................................ 36 
5.9 
 INVESTIGATIONAL PRODUCT PREPARATION AND HANDLING ....................................................................... 37 
5.10 
INFUSION RATES ..................................................................................................................................................... 38 
5.11  
PRODUCT DESCRIPTION ........................................................................................................................................ 39 
5.12 
LABELING AND PACKAGING .................................................................................................................................. 39 
5.13 
SHIPMENT AND STORAGE ...................................................................................................................................... 39 
5.14 
CONCOMITANT MEDICATIONS .............................................................................................................................. 40 
5.14.1  Concomitant Medications on the Day of Infusion ................................................................................ 40 
5.14.2 Prohibited Medications ..................................................................................................................................... 40 
5.15 
INVESTIGATIONAL PRODUCT ACCOUNTABILITY AND DOCUMENTATION...................................................... 41 
5.16 
DESTRUCTION OF USED AND UNUSED INVESTIGATIONAL PRODUCT ............................................................ 41 
6. 
ASSESSMENT OF EFFICACY ............................................................................................................ 42 
6.1. 
PRIMARY EFFICACY ENDPOINT: INCIDENCE OF ACUTE SERIOUS BACTERIAL INFECTION ......................... 42 
6.2. 
SECONDARY EFFICACY ENDPOINTS ..................................................................................................................... 44 
7. 
ASSESSMENT OF PHARMACOKINETICS ..................................................................................... 45 
7.1. 
IGG TROUGH LEVELS ............................................................................................................................................. 45 
7.2. 
IGG SUBCLASSES/SPECIFIC ANTIBODIES – TROUGH LEVELS ......................................................................... 45 
7.3. 
PHARMACOKINETIC PARAMETERS OF TOTAL IGG AND SERUM LEVELS OF IGG SUBCLASSES .................. 45 
8. 
ASSESSMENT OF SAFETY ................................................................................................................ 46 
8.1. 
SAFETY PARAMETERS ............................................................................................................................................ 46 
8.1.1 
Vital Signs ................................................................................................................................................................ 46 
8.1.2 
Routine blood tests .............................................................................................................................................. 47 
8.1.3 
Other safety laboratory parameters ........................................................................................................... 48 
8.2. 
ADVERSE EVENTS ................................................................................................................................................... 48 
8.2.1 
Definition of an Adverse Event (AE) ............................................................................................................ 49 
8.2.2 
Adverse Reaction .................................................................................................................................................. 49 
8.2.3 
Suspected Adverse Reaction ............................................................................................................................ 49 
8.2.4 
Unexpected Adverse Events ............................................................................................................................. 49 
8.2.5 
Serious Adverse Event (SAE) ........................................................................................................................... 49 
8.3. 
DOCUMENTATION OF ADVERSE EVENTS ............................................................................................................ 50 
8.4. 
ASSESSMENT OF ADVERSE EVENTS ..................................................................................................................... 52 
8.4.1 
Assessment of Severity ....................................................................................................................................... 52 
8.4.2 Assessment of Causality .......................................................................................................................................... 52 
8.5. 
REPORTING SERIOUS ADVERSE EVENTS ............................................................................................................ 53 
8.6. 
DRUG SAFETY MONITORING BOARD ................................................................................................................... 55 
8.7. 
WARNINGS AND PRECAUTIONS ............................................................................................................................ 56 
9. 
STATISTICAL METHODS AND SAMPLE SIZE ............................................................................ 57 
9.1. 
STATISTICAL DESIGN/METHOD........................................................................................................................... 57 
9.1.1 
Sample Size ............................................................................................................................................................. 57 
9.1.2 
Analysis Populations ........................................................................................................................................... 59 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 12 of 75 
 
9.1.3 
Demographics ........................................................................................................................................................ 59 
9.1.4 
Primary Efficacy Endpoint ............................................................................................................................... 59 
9.1.5 
 Secondary Efficacy Endpoints ....................................................................................................................... 60 
9.1.6 
 Pharmacokinetic Endpoints ........................................................................................................................... 61 
9.1.7 
 Safety Endpoints .................................................................................................................................................. 61 
9.2. 
LEVEL OF SIGNIFICANCE ........................................................................................................................................ 62 
9.3. 
STATISTICAL SOFTWARE ....................................................................................................................................... 63 
10. 
ETHICS .................................................................................................................................................. 63 
10.1. 
INVESTIGATIONAL REVIEW BOARD/RESEARCH ETHICS BOARD ................................................................... 63 
10.2. 
INFORMED CONSENT AND ASSENT ...................................................................................................................... 63 
10.3. 
CONFIDENTIALITY .................................................................................................................................................. 64 
10.4. 
DECLARATION OF HELSINKI ................................................................................................................................. 65 
11. 
QUALITY CONTROL AND QUALITY ASSURANCE .................................................................... 65 
11.1. 
GENERAL INFORMATION ....................................................................................................................................... 65 
11.2. 
QUALITY CONTROL BY THE MONITORING TEAM .............................................................................................. 65 
11.3. 
QUALITY ASSURANCE BY AN AUDIT TEAM ......................................................................................................... 65 
12. 
DATA HANDLING AND RECORD KEEPING ................................................................................ 66 
12.1. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS ............................................................................................. 66 
12.2. 
DATA COLLECTION AND MANAGEMENT ............................................................................................................. 66 
12.3. 
RECORD KEEPING ................................................................................................................................................... 67 
13. 
CHANGES IN THE CONDUCT OF THE STUDY ............................................................................ 67 
14. 
REPORTING AND PUBLICATION .................................................................................................. 68 
15. 
LIABILITIES AND INSURANCE ....................................................................................................... 68 
16. REFERNCES .................................................................................................................................................... 69 
17. APPENDICES .................................................................................................................................................. 74 
PRINCIPAL INVESTIGATOR’S AGREEMENT ............................................................................................... 75 
 
 
 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 13 of 75 
 
 
List of Tables 
Table 1: Study Timeline................................................................................................................ 30 
Table 2: Infusion rates for GC5107 .............................................................................................. 38 
Table 3: Mean Infection Rates and Power of Study Sample Size ................................................ 58 
Table 4: Schedule of Subject Evaluations - 28 Day Infusion Schedule ....................................... 70 
Table 5: Schedule of Subject Evaluations – 21 Day Infusion Schedule ....................................... 72 
 

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 14 of 75 
 
List of Abbreviations 
 
AE 
Adverse event 
AIDS  
Acquired immune deficiency syndrome  
ALT  
Alanine aminotransferase  
AMS 
Aseptic Meningitis Syndrome 
AST  
Aspartate aminotransferase  
AUC  
Area under the curve  
BAL  
Bronchoalveolar lavage  
BP  
Blood pressure  
BUN  
Blood urea nitrogen  
bw 
Body weight  
°C  
Degrees Celsius  
CK  
Creatine kinase  
CL  
Total body clearance  
Cmax 
Maximum concentration  
Cmin 
Minimum concentration  
CMV  
Cytomegalovirus  
CPMP  
Committee for Proprietary Medicinal Products  
CR  
Clinical Research  
CRF  
Case report form  
CRO  
Contract Research Organization  
CSF 
Cerebrospinal fluid 
CT  
Computed tomography  
CVID  
Common variable immunodeficiency  
D5W 
Dextrose 5 % in water 
DAT  
Direct Antiglobulin (Coombs) test  
DSMB 
Drug Safety Monitoring Board 
EU  
European Union  
°F  
Degrees Fahrenheit  
FDA  
Food and Drug Administration  
g 
Gram 
GCP  
Good Clinical Practice  
GLP  
Good Laboratory Practice  
GMP  
Good Manufacturing Practice  
h 
Hour 
HAV  
Hepatitis A virus  
HBV  
Hepatitis B virus  
HCV  
Hepatitis C virus  
HIPAA 
Health Insurance Portability and Accountability Act 
HIV  
Human immunodeficiency virus  
ICF  
Informed consent form  
ICH  
International Conference on Harmonization  
IDF  
Immune Deficiency Foundation  

Clinical Study Protocol 
Green Cross Corporation 
CONFIDENTIAL 
Protocol Number: GC5107B_P3 
Version 2.0 Amendment 3 
 
Page 15 of 75 
 
IgA  
Immunoglobulin A  
IgG 
Immunoglobulin G  
IGIV 
Immunoglobulin intravenous 
IgM 
Immunoglobulin M  
IP 
Investigational product 
IRB 
Institutional Review Board  
ITP 
Immune Thrombocytopenic Purpura 
ITT 
Intention-to-treat  
IV 
Intravenous  
Kg 
Kilogram 
L 
Liter 
LDH 
Lactate dehydrogenase  
MedDRA 
Medical dictionary for regulatory activities  
mg 
Milligram 
min 
Minute  
mL 
Milliliter 
MRI 
Magnetic resonance imaging  
No. 
Number  
NSAID 
Non-steroidal anti-inflammatory drugs  
NYHA 
New York Heart Association  
PCR 
Polymerase chain reaction  
PHID 
Primary humoral immunodeficiency  
PI 
Principal investigator 
PK 
Pharmacokinetic 
PO 
Oral 
PP 
Per protocol  
PPS 
Per protocol data set 
QA 
Quality Assurance 
QC 
Quality Control 
RBC 
Red Blood Cells 
SAE 
Serious adverse event  
SCIG 
Subcutaneous immunoglobulin 
t1/2 
Elimination half-life  
tmax 
Time point of maximum concentration (Cmax)  
TRALI 
Transfusion related acute lung injury  
USA 
United States of America 
ULN 
Upper limit of normal 
WBC 
White blood cell 
WHO 
World Health Organization