A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease
Phase: PHASE1
Conditions: End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic
Sponsor: Merck Sharp & Dohme LLC

Official Protocol Title:
NCT number:
Document Date:           31-Oct-2023
NCT05656040
A Single-and Multiple Dose Study to Assess the Safety, 
Pharmacokinetics and Pharmacodynamics of 
Subcutaneous MK-2060 in Participants with Chronic 
and/or End-Stage Kidney Disease

PRODUCT: MK-2060
1
PROTOCOL/AMENDMENT NO.: 011-01
MK-2060-011-01 FINAL PROTOCOL
31-OCT-2023
TITLE PAGE
THIS PROTOCOL AND ALL OF THE INFORMATION RELATING TO IT ARE 
CONFIDENTIAL AND PROPRIETARY PROPERTY OF MERCK SHARP & 
DOHME LLC, RAHWAY, NJ, USA (MSD).
Protocol Title: A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics 
and Pharmacodynamics of Subcutaneous MK-2060 in Participants with Chronic and/or End-
Stage Kidney Disease
Protocol Number: 011-01
Compound Number: MK-2060
Sponsor Name: Merck Sharp & Dohme LLC (hereafter called the Sponsor or MSD)
Legal Registered Address:
126 East Lincoln Avenue
P.O. Box 2000
Rahway, NJ 07065 USA
Regulatory Agency Identifying Number(s):
NCT
Not applicable
EU CT
Not applicable
EudraCT
Not applicable
JRCT
Not applicable
WHO
Not applicable
UTN
Not applicable
IND
142,237
Approval Date: 31 October 2023
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Sponsor Signatory
Typed Name:
Title:
Date
Protocol-specific Sponsor contact information can be found in the Investigator Study 
File Binder (or equivalent).
Investigator Signatory
I agree to conduct this clinical study in accordance with the design outlined in this protocol 
and to abide by all provisions of this protocol.
Typed Name:
Title:
Date
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31-OCT-2023
DOCUMENT HISTORY
Document
Date of Issue
Overall Rationale
Amendment 1
31-OCT-2023
This amendment is issued to include the addition 
of a multiple dose panel in participants with 
CKD 4 or 5 and a single dose panel in 
participants with ESKD on peritoneal dialysis.
Original Protocol
31-OCT-2022
Not applicable
PROTOCOL AMENDMENT SUMMARY OF CHANGES
Amendment: 01
Overall Rationale for the Amendment:
This amendment is primarily issued to include the addition of a multiple dose panel in 
participants with CKD 4 or 5 and a single dose panel in participants with ESKD on peritoneal 
dialysis.
Summary of Changes Table
Section Number 
and Name
Description of Change
Brief Rationale
Primary Reason for Amendment
Section 4.1, 
Overall Design
Addition of a multiple dose panel in participants 
with CKD 4 or 5 and a single dose panel in 
participants with ESKD on peritoneal dialysis.
These changes were made in order to include
some participants with CKD5 and to enable
enrollment of ESKD-on peritoneal dialysis 
participants in Phase 3 studies.
Section Number and 
Name
Description of Change
Brief Rationale
Other Changes in Amendment
The structure of the protocol has been 
updated.
To comply with current industry regulations 
and guidelines. This restructuring does not 
affect the clinical or regulatory integrity of 
the protocol. All other relevant changes and 
their primary reasons are included for 
completeness.
Section 1.1, Synopsis
Change of the hypothesized geometric mean 
AUC0-∞ from 1130nM*hr to 11300 nM*hr.
This change was made to correct a 
typographical error and to align with a 
previously issues 19-DEC-2022 PCL #2.
Section 1.2, Schema
Added Figures for study design in the 
multiple dose panel and the single dose 
panel in peritoneal dialysis patients.
This change was made due to the addition of 
a multiple-dose panel in CKD 4 or 5 
participants and a single-dose panel in 
ESKD on peritoneal dialysis participants.
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Section Number and 
Name
Description of Change
Brief Rationale
Section 1.3, Schedule of 
Activities
Addition of footnote “d” to clarify wording 
regarding the Screening 2 visit Hematology, 
Chemistry, Urinalysis (Lab Safety Tests).
This change was made to align with a 
previously issued 09-FEB-2023 PCL #4.
Section 1.3, Schedule of 
Activities
Addition of footnote “e” to clarify wording 
regarding the Screening 1 visit Hemoccult 
test.
This change was made to align with a 
previously issued 15-FEB-2023 PCL #5.
Section 1.3, Schedule of 
Activities
Addition of Part 2 and Part 3 SoA.
Refer to Section 1.2 rationale.
Section 2.1
Addition of text to support study rationale.
This change was made to provide more 
context in support of the study and the 
amendment.
Section 2.2.2, Completed 
Clinical Studies
MK-2060-011-01 and MK-2060-08 were 
added to list of completed clinical studies.
This change was made to include new data 
from completed clinical studies.
Section 2.2.3, Ongoing 
Clinical Studies
Addition of study data/information for MK-
2060-007, MK-2060-009, MK-2060-012, 
and MK-2060-013. 
This change was made to include new data 
from ongoing clinical studies.
Section 3, Hypotheses, 
Objectives and Endpoints
Change of the hypothesized geometric mean 
AUC0-∞ from 1130nM*hr to 11300 nM*hr.
Refer to Section 1.1 rationale.
Section 4.2, Scientific 
Rationale for Study 
Design
Clarifying wording due to addition of a 
multiple dose panel in participants with 
CKD 4 or 5 and a single dose panel in 
participants with ESKD on peritoneal 
dialysis.
Refer to Section 1.2 rationale.
Section 4.2.1.2, 
Pharmacokinetic 
Endpoints
Clarifying wording due to addition of a 
multiple dose panel in participants with 
CKD 4 or 5 and a single dose panel in 
participants with ESKD on peritoneal 
dialysis.
Refer to Section 1.2 rationale.
Section 4.2.2, Rationale 
for the Use of Placebo
Clarifying wording due to addition of a 
multiple dose panel in participants with 
CKD 4 or 5 and a single dose panel in 
participants with ESKD on peritoneal 
dialysis.
Refer to Section 1.2 rationale.
Section 4.3, Justification 
for Dose
Added dose justification for Part 2 and Part 
3.
Refer to Section 1.2 rationale.
Section 5.1, Inclusion 
Criteria
Changed inclusion criteria to clarify that the 
eGFR value used to determine eligibility
would be the mean of 2 values taken at least 
72 hours apart.
This change was made to remove ambiguity 
about eGFR inclusion criteria as it was 
stated as value at screening visit, but there 
are 2 screening visits per Section 1.2.
Section 5.1, Inclusion 
Criteria
Reduced the lower limit eGFR value from 
15 to 10.
This change was made to reduce screen 
failure in otherwise stable individuals with 
CKD and thereby also include some 
participants with CKD5. The eGFR lower
limit of 10 was selected as participants with 
eGFR above this level would be less likely 
to transition to dialysis during the time 
frame of the study.
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Section Number and 
Name
Description of Change
Brief Rationale
Section 5.2, Exclusion 
Criteria
Removed clopidogrel use as an exclusion 
for the study.
This change was made due to new data 
showing coadministration of clopidogrel 
with MK-2060 in P008 did not impact time 
to hemostasis or lead to any bleeding related 
AEs.
Section 5.2, Exclusion 
Criteria
Added an exclusion criterion surrounding 2
measurements of eGFR (taken at least 
72 hours apart) are different by more than 
30%. 
This change was made to ensure participants 
with rapidly fluctuating renal function are 
not enrolled and that eGFR is at or near 
steady state.
Section 5.3.2.1, Caffeine
Restrictions
Added caffeine restrictions for Part 2 and 
Part 3 and clarified restrictions for Part 1.
Refer to Section 1.2 rationale.
Section 6.1, Study 
Intervention(s) 
Administered
Updated Table°1 to include information for 
Part 2 and Part 3.
Refer to Section 1.2 rationale.
Section 6.3.1, 
Intervention Assignment
Added intervention assignment information 
for Part 2 and Part 3.
Refer to Section 1.2 rationale.
Section 6.5, Concomitant 
Therapy
Removed clopidogrel use as prohibited for 
the study.
See rationale for Section 5.2.
Section 8.1.7, 
Assignment of 
Treatment/Randomization 
Number
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 8.1.8.1, Timing 
of Dose Administration
Reduced total dosing time from 2 minutes 
to 1 minute.
This change was made to decrease the 
allowable study medication administration 
window.
Section 8.1.9, 
Discontinuation and 
Withdrawal
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 8.1.11, 
Domiciling
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 8.3.2.1, Resting 
Vital Signs
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 8.3.3, 
Electrocardiogram
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 8.3.3, 
Electrocardiogram
Change of allowable procedure window for 
Day 1 predose ECGs from within 24 hours 
prior to dosing MK-2060/placebo to within 
3 hours prior to dosing MK-2060/placebo.
This change was made to correct a 
typographical error and to align with a 
previously issued 01-FEB-2023 PCL #3.
Section 8.3.6, Hemoccult 
Test
Clarifying wording surrounding when to 
provide and return hemoccult tests.
Refer to Section 8.3.3 rationale.
Section 8.3.8.1, Systemic 
Injection Reaction 
Assessment
Clarified wording surrounding how long 
participants will be monitored during the 
administration of MK-2060/placebo – now 
participants will be monitored for at least 4 
hours up to 24 to 48 hours postdose at the 
CRU after the initiation of administration.
This change was made following 
investigator/site feedback.
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Section Number and 
Name
Description of Change
Brief Rationale
Section 8.6.1, Blood 
Collection for Plasma 
MK-2060
Removal of statement “Samples taken on 
the day of infusion will be collected in the 
opposite arm from the infusion site.”
This change was made to correct a 
typographical error.
Section 8.7, 
Pharmacodynamics
Clarified wording that sample collection, 
storage, and shipment instructions for 
pharmacodynamic samples will be provided 
in the Study Operations Manual.
This change was made to correct a 
typographical error.
Section 8.9, Future 
Biomedical Research 
Sample Collection
Clarified what specimens be obtained as 
part of FBR.
This change was made to correct a 
typographical error.
Section 8.11.3, Poststudy
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 8.11.4, 
Participants Discontinued 
From Study Intervention 
but Continuing to be 
Monitored in the Study
Addition of CKD5 as a possible group of 
participants that may progress to ESKD
during the study.
Refer to Section 5.1 rationale.
Section 8.11.6, Critical 
Procedures Based on 
Study Objectives: Timing 
of Procedure
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 8.11.7, Study 
Design/Procedures 
Modifications Permitted 
Within Protocol 
Parameters
Updated to include information and/or 
wording regarding the addition of Part 2 and 
Part 3.
Refer to Section 1.2 rationale.
Section 9.4, Analysis 
Endpoints
Change of the hypothesized geometric mean 
AUC0-∞ from 11345 nM*hr to 11300 
nM*hr.
Refer to Section 1.1 rationale.
Section 9.9, Sample Size 
and Power Calculations
Change of protocol number from MK-6194 
to MK-2060.
This change was made to correct a 
typographical error and to align with a 
previously issued 11-NOV-2022 PCL #1.
Section 10.3, Appendix 3: 
Adverse Events: 
Definitions and 
Procedures for 
Recording, Evaluating, 
Follow-up, and Reporting
Replacement of “Sponsor’s product” with 
“Study intervention” throughout the section.
This change was made due to incorrect 
standard text.
Section 10.8 Appendix 8, 
Blood Volume Tables
Addition of Part 2 and Part 3 blood volume 
tables.
Refer to Section 1.2 rationale.
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TABLE OF CONTENTS
DOCUMENT HISTORY ........................................................................................................3
PROTOCOL AMENDMENT SUMMARY OF CHANGES...............................................3
1
PROTOCOL SUMMARY ............................................................................................14
1.1
Synopsis.................................................................................................................14
1.2
Schema ..................................................................................................................19
1.3
Schedule of Activities...........................................................................................20
1.3.1
Part 1............................................................................................................20
1.3.2
Part 2............................................................................................................26
1.3.3
Part 3............................................................................................................33
2
INTRODUCTION..........................................................................................................39
2.1
Study Rationale....................................................................................................39
2.2
Background ..........................................................................................................39
2.2.1
Pharmaceutical and Therapeutic Background .............................................39
2.2.2
Completed Clinical Studies..........................................................................39
2.2.3
Ongoing Clinical Studies.............................................................................41
2.3
Benefit/Risk Assessment......................................................................................41
3
HYPOTHESES, OBJECTIVES, AND ENDPOINTS................................................42
4
STUDY DESIGN............................................................................................................45
4.1
Overall Design......................................................................................................45
4.2
Scientific Rationale for Study Design.................................................................45
4.2.1
Rationale for Endpoints ...............................................................................46
4.2.1.1
Safety Endpoints................................................................................46
4.2.1.2
Pharmacokinetic Endpoints ...............................................................47
4.2.1.3
Pharmacodynamic Endpoints.............................................................47
4.2.1.4
Planned Exploratory Biomarker Research.........................................48
4.2.1.4.1
Planned Genetic Analysis ........................................................48
4.2.1.5
Future Biomedical Research..............................................................48
4.2.2
Rationale for the Use of Placebo .................................................................48
4.3
Justification for Dose...........................................................................................48
4.4
Beginning and End-of-Study Definition ............................................................49
4.4.1
Clinical Criteria for Early Study Termination .............................................50
5
STUDY POPULATION ................................................................................................51
5.1
Inclusion Criteria.................................................................................................51
5.2
Exclusion Criteria................................................................................................53
5.3
Lifestyle Considerations......................................................................................56
5.3.1
Meals and Dietary Restrictions....................................................................56
5.3.2
Caffeine, Alcohol, and Tobacco Restrictions ..............................................57
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5.3.2.1
Caffeine Restrictions..........................................................................57
5.3.2.2
Alcohol Restrictions...........................................................................57
5.3.2.3
Tobacco Restrictions..........................................................................57
5.3.3
Activity Restrictions ....................................................................................57
5.4
Screen Failures.....................................................................................................58
5.5
Participant Replacement Strategy......................................................................58
6
STUDY INTERVENTION............................................................................................59
6.1
Study Intervention(s) Administered...................................................................59
6.2
Preparation/Handling/Storage/Accountability .................................................61
6.2.1
Dose Preparation..........................................................................................61
6.2.2
Handling, Storage, and Accountability........................................................61
6.3
Measures to Minimize Bias: Randomization and Blinding..............................62
6.3.1
Intervention Assignment..............................................................................62
6.3.2
Stratification.................................................................................................62
6.3.3
Blinding........................................................................................................62
6.4
Study Intervention Compliance..........................................................................63
6.5
Concomitant Therapy..........................................................................................63
6.5.1
Rescue Medications and Supportive Care ...................................................65
6.6
Dose Modification (Escalation/Titration/Other)...............................................65
6.6.1
Stopping Rules.............................................................................................65
6.7
Intervention After the End of the Study............................................................66
6.8
Clinical Supplies Disclosure................................................................................66
6.9
Standard Policies..................................................................................................66
6.9.1
Study Site Retention Samples......................................................................66
7
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
WITHDRAWAL............................................................................................................67
7.1
Discontinuation of Study Intervention...............................................................67
7.2
Participant Withdrawal From the Study...........................................................67
7.3
Lost to Follow-up .................................................................................................68
8
STUDY ASSESSMENTS AND PROCEDURES........................................................69
8.1
Administrative and General Procedures ...........................................................69
8.1.1
Informed Consent.........................................................................................69
8.1.1.1
General Informed Consent.................................................................70
8.1.1.2
Consent and Collection of Specimens for Future Biomedical 
Research.............................................................................................70
8.1.2
Inclusion/Exclusion Criteria ........................................................................70
8.1.3
Participant Identification Card.....................................................................70
8.1.4
Medical History ...........................................................................................71
8.1.5
Prior and Concomitant Medications Review...............................................71
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8.1.5.1
Prior Medications...............................................................................71
8.1.5.2
Concomitant Medications..................................................................71
8.1.6
Assignment of Screening Number...............................................................71
8.1.7
Assignment of Treatment/Randomization Number.....................................71
8.1.8
Study Intervention Administration ..............................................................72
8.1.8.1
Timing of Dose Administration.........................................................72
8.1.9
Discontinuation and Withdrawal .................................................................72
8.1.9.1
Withdrawal From Future Biomedical Research ................................72
8.1.10
Participant Blinding/Unblinding..................................................................73
8.1.11
Domiciling ...................................................................................................73
8.1.12
Calibration of Equipment.............................................................................73
8.2
Efficacy/Immunogenicity Assessments ..............................................................74
8.3
Safety Assessments...............................................................................................74
8.3.1
Physical Examinations.................................................................................74
8.3.1.1
Body Weight and Height ...................................................................74
8.3.1.2
Body Mass Index (BMI)....................................................................74
8.3.2
Vital Signs....................................................................................................74
8.3.2.1
Resting Vital Signs ............................................................................75
8.3.2.2
Orthostatic Vital Signs.......................................................................75
8.3.3
Electrocardiograms ......................................................................................75
8.3.4
24-Hour Urine Protein, 24-Hour Urine Creatinine and Spot Urine 
Collection for Urine Protein: Urine Creatinine Ratio (uPCR).....................77
8.3.5
Clinical Safety Laboratory Assessments .....................................................77
8.3.6
Hemoccult Test ............................................................................................77
8.3.7
Photograph of Rash......................................................................................77
8.3.8
Management of Injection Reaction During and Post-Dose .........................78
8.3.8.1
Systemic Injection Reaction Assessment...........................................78
8.3.8.2
Local Injection Reaction Assessment................................................78
8.4
Adverse Events, Serious Adverse Events, and Other Reportable Safety 
Events....................................................................................................................79
8.4.1
Time Period and Frequency for Collecting AE, SAE, and Other 
Reportable Safety Event Information ..........................................................80
8.4.2
Method of Detecting AEs, SAEs, and Other Reportable Safety Events......82
8.4.3
Follow-up of AE, SAE, and Other Reportable Safety Event Information...82
8.4.4
Regulatory Reporting Requirements for SAE .............................................82
8.4.5
Pregnancy and Exposure During Breastfeeding ..........................................83
8.4.6
Disease-related Events and/or Disease-related Outcomes Not Qualifying 
as AEs or SAEs............................................................................................83
8.4.7
Events of Clinical Interest............................................................................83
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8.5
Treatment of Overdose........................................................................................84
8.6
Pharmacokinetics.................................................................................................84
8.6.1
Blood Collection for Plasma MK-2060 .......................................................84
8.7
Pharmacodynamics..............................................................................................84
8.7.1
Blood Collection for PT, aPTT, FXI Activity .............................................84
8.7.2
Blood for Plasma ADA................................................................................85
8.8
Biomarkers ...........................................................................................................85
8.8.1
Planned Genetic Analysis Sample Collection..............................................85
8.9
Future Biomedical Research Sample Collection...............................................85
8.10
Health Economics Medical Resource Utilization and Health Economics.......85
8.11
Visit Requirements...............................................................................................85
8.11.1
Screening......................................................................................................85
8.11.2
Treatment Period..........................................................................................86
8.11.3
Poststudy......................................................................................................86
8.11.4
Participants Discontinued From Study Intervention but Continuing to be 
Monitored in the Study ................................................................................86
8.11.5
Safety Phone Call Follow-Up ......................................................................86
8.11.6
Critical Procedures Based on Study Objectives: Timing of Procedure.......87
8.11.7
Study Design/Dosing/Procedures Modifications Permitted Within 
Protocol Parameters .....................................................................................89
9
STATISTICAL ANALYSIS PLAN .............................................................................91
9.1
Statistical Analysis Plan Summary.....................................................................91
9.2
Responsibility for Analyses.................................................................................91
9.3
Hypotheses/Estimation ........................................................................................91
9.4
Analysis Endpoints...............................................................................................91
9.5
Analysis Populations............................................................................................92
9.6
Statistical Methods...............................................................................................92
9.7
Interim Analyses ..................................................................................................93
9.8
Multiplicity ...........................................................................................................93
9.9
Sample Size and Power Calculations .................................................................93
10
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS.....................................................................................................94
10.1
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations........94
10.1.1
Code of Conduct for Interventional Clinical Trials .....................................94
10.1.2
Financial Disclosure.....................................................................................97
10.1.3
Data Protection.............................................................................................98
10.1.3.1
Confidentiality of Data ......................................................................98
10.1.3.2
Confidentiality of Participant Records...............................................98
10.1.3.3
Confidentiality of IRB/IEC Information............................................99
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10.1.4
Committees Structure...................................................................................99
10.1.5
Publication Policy........................................................................................99
10.1.6
Compliance with Study Registration and Results Posting Requirements ...99
10.1.7
Compliance with Law, Audit, and Debarment ..........................................100
10.1.8
Data Quality Assurance .............................................................................100
10.1.9
Source Documents .....................................................................................101
10.1.10
Study and Site Closure...............................................................................102
10.2
Appendix 2: Clinical Laboratory Tests............................................................103
10.3
Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting.............................................................105
10.3.1
Definitions of Medication Error, Misuse, and Abuse................................105
10.3.2
Definition of AE ........................................................................................105
10.3.3
Definition of SAE ......................................................................................106
10.3.4
Additional Events Reported.......................................................................107
10.3.5
Recording AE and SAE .............................................................................108
10.3.6
Reporting of AEs, SAEs, and Other Reportable Safety Events to the 
Sponsor ......................................................................................................111
10.4
Appendix 4: Medical Device and Drug–Device Combination Products: 
Product Quality Complaints/Malfunctions: Definitions, Recording, and 
Follow-up ............................................................................................................112
10.5
Appendix 5: Contraceptive Guidance..............................................................113
10.5.1
Definitions..................................................................................................113
10.5.2
Contraceptive Requirements......................................................................114
10.6
Appendix 6: Collection and Management of Specimens for Future 
Biomedical Research..........................................................................................116
10.7
Appendix 7: Country-specific Requirements..................................................120
10.8
Appendix 8: Blood Volume Tables...................................................................121
10.9
Appendix 9: Algorithm for Assessing Out of Range Laboratory Values .....123
10.10 Appendix 10: Abbreviations .............................................................................124
11
REFERENCES.............................................................................................................127
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LIST OF TABLES
Table 1
Study Interventions......................................................................................60
Table 2
Sample Allocation Schedule for Part 1........................................................62
Table 3
Sample Allocation Schedule for Part 2........................................................62
Table 4
Sample Allocation Schedule for Part 3........................................................62
Table 5
Local Injection Reaction Assessment..........................................................79
Table 6
Reporting Time Periods and Time Frames for Adverse Events and 
Other Reportable Safety Events ..................................................................81
Table 7
Pharmacokinetic, Pharmacodynamic and Safety (Blood/Urine) 
Collection Windows for Part1.....................................................................87
Table 8
Pharmacokinetic, Pharmacodynamic and Safety (Blood/Urine) 
Collection Windows for Part 2....................................................................88
Table 9
Pharmacokinetic, Pharmacodynamic and Safety (Blood/Urine) 
Collection Windows for Part 3....................................................................88
Table 10
Protocol-required Safety Laboratory Assessments....................................103
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LIST OF FIGURES
Figure 1
Study Design for Part 1................................................................................19
Figure 2
Study Design for Part 2................................................................................19
Figure 3
Study Design for Part 3................................................................................19
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1
PROTOCOL SUMMARY
1.1
Synopsis
Protocol Title: A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics 
and Pharmacodynamics of Subcutaneous MK-2060 in Participants with Chronic and/or End-
Stage Kidney Disease
Short Title: MK-2060 PK Study
Acronym: N/A
Hypotheses, Objectives, and Endpoints:
Hypotheses are aligned with objectives in the Objectives and Endpoints table.
This study is to be conducted in adult participants with chronic and/or end-stage kidney 
disease.
Primary Objectives
Primary Endpoints
Part 1: To evaluate the safety and 
tolerability of MK-2060 following single-
dose SC administration in adult participants 
with Stage 4 or 5 Chronic Kidney Disease.
Part 2: To evaluate the safety and 
tolerability of MK-2060 following multiple-
dose SC administration in adult participants 
with Stage 4 or 5 Chronic Kidney Disease.
Part 3: To evaluate the safety and 
tolerability of MK-2060 following single-
dose SC administration in adult participants 
with End-Stage Kidney Disease on 
Peritoneal Dialysis.
Bleeding related AEs, AEs, and 
discontinuations due to AEs
Part 1: To evaluate plasma 
pharmacokinetics of MK-2060 following 
single-dose SC administration in adult 
participants with Stage 4 or 5 Chronic 
Kidney Disease.
Hypothesis:
The true geometric mean of AUC0-∞ after a 
single well tolerated dose of MK-2060 in 
adult participants with Stage 4 or 5 Chronic 
Kidney Disease is at least 11300 nM*hr.
Measurement of MK-2060 plasma AUC0-
∞, AUC0-168, Cmax, C168, Tmax, 
terminal t1/2, CL/F and Vz/F
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Part 2: To evaluate plasma 
pharmacokinetics of MK-2060 following 
multiple-dose SC administration in adult 
participants with Stage 4 or 5 Chronic 
Kidney Disease.
Estimation:
The effect of multiple-dose SC 
administration of MK-2060 in adult 
participants with Stage 4 or 5 Chronic 
Kidney Disease will be estimated.
Part 3: To evaluate plasma 
pharmacokinetics of MK-2060 following 
single-dose SC administration in adult 
participants with End-Stage Kidney Disease 
on Peritoneal Dialysis.
Estimation:
The effect of single-dose SC administration 
of MK-2060 in adult participants with End 
Stage Kidney Disease on Peritoneal 
Dialysis will be estimated.
Secondary Objective
Secondary Endpoint
Part 1: To evaluate the effect of MK-2060 
on aPTT following single dose SC 
administration in adult participants with 
Stage 4 or 5 Chronic Kidney Disease.
Part 2: To evaluate the effect of MK-2060 
on aPTT following multiple-dose SC 
administration in adult participants with 
Stage 4 or 5 Chronic Kidney Disease.
Part 3: To evaluate the effect of MK-2060 
on aPTT following single dose SC 
administration in adult participants with 
End-Stage Kidney Disease on Peritoneal 
Dialysis.
aPTT fold change from baseline
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Overall Design:
Study Phase
Phase 1
Primary Purpose
Treatment
Indication
Thrombosis
Population
Patient: Adult participants with CKD
Study Type
Interventional
Intervention Model
Single Group
This is a multi site study.
Type of Control
Placebo
Study Blinding
Double-blind
Blinding Roles
Participants or Subjects
Estimated Duration of Study
The Sponsor estimates that the study will 
require approximately 16 to 18 months from 
the time the first participant (or their legally 
acceptable representative) provides 
documented informed consent until the last 
participant’s last study-related contact.
Number of Participants:
Approximately 12 participants will be randomized to receive MK-2060 or placebo in a 3:1 
ratio (9 active and 3 placebo) in both Part 1 and Part 2 and approximately 9 participants will 
be allocated to receive MK-2060 in Part 3.
Intervention Groups and Duration:
Arm Name
Intervention 
Name
Unit Dose 
Strength(s)
Dosage 
Level(s)
Route of 
Administration
Regimen/
Treatment 
Period/
Vaccination 
Regimen
Use
MK-2060
MK-2060
15 mg/mL
30 mg
SC
Part 1: Day 1
Part 2: Days 1, 
2, 3, 4, 8, 15, 
and 22
Part 3: Day 1
Test Product
Placebo
Placebo
Saline
0 mg
SC
Part 1: Day 1
Part 2: Days 1, 
2, 3, 4, 8, 15, 
and 22
Placebo
SC=subcutaneous; USP=United States Pharmacopeia
Placebo SC (0.9% sodium chloride infusion, USP sterile saline)
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Total Number of Intervention Groups/Arms
There will be 3 intervention groups.
Duration of Participation
Part 1: Each participant will participate in 
the study for approximately 19 weeks from 
the time the participant provides 
documented informed consent through the 
final contact. After a screening phase of 
4 weeks, each participant will receive 
assigned intervention for approximately 
1 day. After the end-of-treatment each 
participant will be followed for 
approximately 13 weeks.
Part 2: Each participant will participate in 
the study for approximately 20 weeks from 
the time the participant provides 
documented informed consent through the 
final contact. After a screening phase of 
4 weeks, each participant will receive 
assigned intervention for approximately 
4 weeks (4 consecutive days of loading 
doses followed by weekly single dose x 3). 
After the end-of-treatment each participant 
will be followed for approximately 
13 weeks.
Part 3: Each participant will participate in 
the study for approximately 23 weeks from 
the time the participant provides 
documented informed consent through the 
final contact. After a screening phase of 
4 weeks, each participant will receive 
assigned intervention for approximately 
1 day. After the end-of-treatment each 
participant will be followed for 
approximately 17 weeks.
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Study Governance Committees:
Executive Oversight Committee
No
Data Monitoring Committee
No
Clinical Adjudication Committee
No
There are no governance committees in this study. Regulatory, ethical, and study oversight 
considerations are outlined in Appendix 1.
Study Accepts Healthy Participants: No
A list of abbreviations is in Appendix 10.
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1.2
Schema
The study design is depicted in Figure 1, Figure 2, and Figure 3.
Figure 1
Study Design for Part 1
Figure 2
Study Design for Part 2
Figure 3
Study Design for Part 3
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1.3
Schedule of Activities
1.3.1
Part 1
Part 1
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8
12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
60 (±5 Days)
90 Poststudyb (±5 
Days)
104 Phone 
Follow-upc (±5 
Days)
Notes
Administrative 
Procedures
Informed Consent
X
Sec. 5.1, 8.1.1.1
Informed Consent for 
FBR
X
Sec. 5.1, 8.1.1.2
Inclusion/Exclusion 
Criteria
X
X
X
Sec. 5.1, 5.2, 8.1.2
Participant ID Card
X
Sec. 8.1.3
Participant ID Bracelet
X
Sec. 8.11.2
Medical History
X
X
X
Sec. 8.1.4
Assignment of Screening 
Number 
X
Sec. 8.1.6
Assignment of 
Randomization Number
X
The randomization number 
is assigned at the time of 
study drug administration. 
Sec. 5.5, 8.1.7
Prior/Concomitant 
Medication Review
X----------------------------------------------------------------------------------------------------------------------X
Sec. 5.2, 6.5, 8.1.5
Safety/Clinic 
Procedures
Full physical examination
X
X
X
X
X
Sec. 8.3.1, 8.3.7
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Part 1
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8
12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
60 (±5 Days)
90 Poststudyb (±5 
Days)
104 Phone 
Follow-upc (±5 
Days)
Notes
Targeted physical 
examination 
X
X
Sec. 8.3.1, Sec. 8.3.7
Height
X
Sec. 8.3.1
Weight
X
X
BMI to be taken only at 
Screening 1. Sec. 8.3.1
Orthostatic VS (HR, BP)
X
X
X
Sec. 8.3.2.2.
Semi-recumbent VS (HR, 
BP)
X
X--------------------X
X
X
X
X
X
X
Day 1 measurements will 
be at predose, 1- and 12-
hours postdose. Sec. 8.3.2
RR and body temperature
X
X
X
X
X
X
X
X
Sec. 8.3.2.
12-lead ECG
X
X
X
X
X
X
X
Sec. 8.3.3.
Standard Meals
X---------------X
Sec. 5.3.1.
Domiciling
X-------------------------------X
Sec. 8.1.11
MK-2060/Placebo 
Administration
X
MK-2060/Placebo will be 
administered SC at Time 0. 
Refer to Sec. 6.2, 8.1.8 and 
the Study Pharmacy 
Manual for additional 
information on the 
preparation and 
administration of the study 
drug.
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Part 1
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8
12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
60 (±5 Days)
90 Poststudyb (±5 
Days)
104 Phone 
Follow-upc (±5 
Days)
Notes
Local Injection Site 
Reaction
X X
X
X
X
X
X
Note: Participants who call 
the CRU to report an 
injection site reaction on 
Days 4, 5, and/or 7 may be 
asked to return to the CRU 
as soon as possible for an 
additional assessment. Sec. 
8.3.7.
AE/SAE Review
X---------------------------------------------------------------------------------------------------------------------X
All NSAEs and SAEs will 
be recorded up to 104-days 
postdose (inclusive). Sec. 
8.4
Laboratory Procedures
Serum hCG (WOCBP 
only)
X
X
X
Appendices 2 and 8
Serum FSH - (WONCBP 
only)
X
Appendices 2, 5, and 8
HIV, hepatitis B and C 
screen (per site SOP)
X
Sec. 5.2, Appendices 2 and 
8
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Part 1
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8
12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
60 (±5 Days)
90 Poststudyb (±5 
Days)
104 Phone 
Follow-upc (±5 
Days)
Notes
Drug and Alcohol Screen 
(per site SOP)
X
X
Screening and predose 
drug/alcohol screen are 
mandatory (predose drug 
screen may occur in the 
evening prior to Day 1 at 
the time of admission); any 
additional drug/alcohol
screen is conducted per site 
SOP. Sec. 8.3.5 and 
Appendix 2
24-Hour Urine Protein 
Collection 
X
The 24-hour urine 
collection will begin the 
evening before dosing. Sec. 
8.3.4, Appendix 2.
24-Hour Urine Creatinine 
Collection
X
The 24-hour urine 
collection will begin the 
evening before dosing. Sec. 
8.3.4, Appendix 2.
Spot Urine Collection for 
Urine Protein: Urine 
Creatinine Ratio
X
X
X
If a participant is unable to 
produce a urine sample 12-
hours postdose, this spot 
urine can be collected the 
next time the participant is 
able to void. Sec. 8.3.4, 
Appendix 2
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Part 1
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8
12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
60 (±5 Days)
90 Poststudyb (±5 
Days)
104 Phone 
Follow-upc (±5 
Days)
Notes
Hematology, Chemistry, 
Urinalysis
X
Xd
X
X
X
X
X
Hematology/Chemistry/Uri
nalysis will be obtained 
after an 8-hour fast. 
Predose tests can be 
conducted up to 24 hours 
prior to dosing. Sec. 8.3.5, 
Appendices 2 and 8
aPTT and PT at local lab
X
X
X
X
X
X
X
Sec. 5.2, 8.3.5, Appendices 
2 and 8
Hemoccult test
Xe
X
X
X
X
X
X
X
X
Sec. 8.3.6 
Biomarkers
Blood for Genetic 
Analysisf
X
Collected predose from 
enrolled participants only. 
Sec. 8.8.1, Appendix 8
Pharmacokinetics
Blood for Plasma MK-
2060 
X
X
X
X
X
X
X
X
X
X
X
X
X
Sec. 8.6.1, Appendix 8, and 
Study Operations Manual
Pharmacodynamics
Blood for PT/aPTT/FXI 
activity by central lab
X
X
X
X
X
X
X
X
X
X
X
X
X
Sec. 8.7.1, Appendix 8, and 
Study Operations Manual
Blood for plasma ADA
X
X
X
X
X
X
Sec. 8.7.2, Appendix 8, and 
Study Operations Manual
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Part 1
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8
12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
60 (±5 Days)
90 Poststudyb (±5 
Days)
104 Phone 
Follow-upc (±5 
Days)
Notes
ADA=antidrug antibody; aPTT=activated partial thromboplastin time; AE=adverse event; BMI=body mass index; BP=blood pressure; CRU=clinical research unit; D=Day; 
DNA=deoxyribonucleic acid, ECG=electrocardiogram; FBR=future biomedical research, FSH=follicle stimulating hormone; FXI=factor XI; HIV=human immunodeficiency 
virus; hCG=human chorionic gonadotropin; HR=heart rate; ID=identification; IEC=Independent Ethics Committee; IRB=Institutional Review Board; NSAE=nonserious adverse 
event; PT=prothrombin time; RR=respiratory rate; SAE=serious adverse event; SC=subcutaneous; SOP=standard operating procedure; VS=vital signs; WOCBP=women of 
childbearing potential; WONCBP=women of nonchildbearing potential
a. Screening 2 should occur within 96 hours prior to Day 1. If Screening 1 occurs within 96 hrs prior to administration of the dose of study drug, Screening 2 is not required.
b. The poststudy visit will occur approximately 90 days following administration of study drug. Procedures outlined in the poststudy visit may obtained on Day 90 (±5 days)
Follow up on any clinical or laboratory AEs should occur in person if the poststudy visit occurs prior to 90 days following administration of study drug. If a participant 
discontinues for any reason at any time during the course of the study the participant may be asked to return to the clinic to complete the poststudy visit. The investigator may 
decide to perform the poststudy visit at the time of discontinuation or as soon as possible after discontinuation as outlined in Sections 7.1 and 8.1.9.
c. At the discretion of the investigator an in-person follow-up may be performed.
d. If Screening 2 occurs on Day -1, only obtain predose Hematology, Chemistry, Unrinalysis lab safety tests (these results will be used to satisfy both the Screening 2 and 
predose safety lab tests).
e. Hemoccult test will be provided to a participant at Screening 1 visit and returned at Screening 2 visit or prior to dosing at the time scheduled by the investigator, if Screening 2 
visit does not occur.
f. This sample should be drawn for planned analysis of the association between genetic variants in DNA and drug response. This sample will not be collected at the site if there is
either a local law or regulation prohibiting collection, or if the IRB/IEC does not approve the collection of the sample for this purpose. If the sample is collected, leftover
extracted DNA will be stored for future biomedical research once the participant signs the FBR consent. If the planned genetic analysis is not approved, but FBR is approved and
consent is given, this sample will be collected for the purpose of FBR. Blood for genetic analysis should be collected only once per participant after randomization.
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1.3.2
Part 2
Part 2
Screening 
≤28 days 
to Day 1
Intervention
Post-
study
Notes
Scheduled Timing
(Week)
Screening 1
Screening 2a
Week 1
Week 
2
Week 
3
Week 4
Post Week 4
Scheduled Timing 
(Day)
1
2
3
4
8
10 15
17 22
23
26 29
35 42 49 63 81
111
130
Visit Window 
(Day)
NA NA NA NA NA ±1 NA ±1 NA NA ±1 NA ±2 ±2 ±2 ±2 ±3
±3
±7
Administrative 
Procedures
Informed Consent
X
Sec. 5.1, 8.1.1.1
Informed Consent 
for FBR
X
Sec. 5.1, 8.1.1.2
Inclusion/Exclusion 
Criteria
X
X
X
Sec. 5.1, 5.2, 8.1.2
Participant ID Card
X
Sec. 8.1.3
Participant ID 
Bracelet
X
Sec. 8.11.2
Medical History
X
X
X
Sec. 8.1.4
Assignment of 
Screening Number 
X
Sec. 8.1.6
Assignment of 
Randomization
Number
X
The randomization number is 
assigned at the time of study drug 
administration. Sec. 5.5, 8.1.7
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Part 2
Screening 
≤28 days 
to Day 1
Intervention
Post-
study
Notes
Scheduled Timing
(Week)
Screening 1
Screening 2a
Week 1
Week 
2
Week 
3
Week 4
Post Week 4
Scheduled Timing 
(Day)
1
2
3
4
8
10 15
17 22
23
26 29
35 42 49 63 81
111
130
Visit Window 
(Day)
NA NA NA NA NA ±1 NA ±1 NA NA ±1 NA ±2 ±2 ±2 ±2 ±3
±3
±7
Prior/Concomitant 
Medication Review
X----------------------------------------------------------------------------------------------------------------------X Sec. 5.2, 6.5, 8.1.5
Safety/Clinic 
Procedures
Full physical 
examination
X
X
X
X
X
X
X
Sec. 8.3.1, 8.3.7
Targeted physical 
examination 
X
X
X
X X
X
Sec. 8.3.1, Sec. 8.3.7
Height
X
Sec. 8.3.1
Weight
X
X
BMI to be taken only at Screening 
1. Sec. 8.3.1
Orthostatic VS (HR, 
BP)
X
X
X
X
X
X
Days 1, 4, 8, 15 and 22
measurements will be predose; 
Sec. 8.3.2.2.
Semi-recumbent VS 
(HR, BP)
X
X
X
X
X
X
X
X
X
X
X
X
Days 1, 4, 8, 15 and 22
measurements will be predose;
Sec. 8.3.2
RR and body 
temperature
X
X
X
X
X
X
Days 1, 4, 8, 15 and 22
measurements will be predose; 
Sec. 8.3.2.
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Part 2
Screening 
≤28 days 
to Day 1
Intervention
Post-
study
Notes
Scheduled Timing
(Week)
Screening 1
Screening 2a
Week 1
Week 
2
Week 
3
Week 4
Post Week 4
Scheduled Timing 
(Day)
1
2
3
4
8
10 15
17 22
23
26 29
35 42 49 63 81
111
130
Visit Window 
(Day)
NA NA NA NA NA ±1 NA ±1 NA NA ±1 NA ±2 ±2 ±2 ±2 ±3
±3
±7
12-lead ECG
X
X
X
X
X
X
X
X
Days 1, 4, 8, 15 and 22
measurements will be predose; 
Sec. 8.3.3.
Domiciling
X
X
X
X
X
X
X
Sec. 8.1.11.
Standard Meals
X
X
X
X
Sec. 5.3.1.
MK-2060/Placebo 
Administration
X
X
X
X
X
X
X
MK-2060/Placebo will be 
administered SC at Time 0. Refer 
to Sec. 6.2, 8.1.8 and the Study 
Pharmacy Manual for additional 
information on the preparation 
and administration of the study 
drug.
Local Injection Site 
Reaction
X
X
X
X
X
X
X
X
X
X
X
Note: Participants who call the 
CRU to report an injection site 
reaction on non-visit days may be 
asked to return to the CRU as 
soon as possible for an additional 
assessment. Sec. 8.3.7.
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Part 2
Screening 
≤28 days 
to Day 1
Intervention
Post-
study
Notes
Scheduled Timing
(Week)
Screening 1
Screening 2a
Week 1
Week 
2
Week 
3
Week 4
Post Week 4
Scheduled Timing 
(Day)
1
2
3
4
8
10 15
17 22
23
26 29
35 42 49 63 81
111
130
Visit Window 
(Day)
NA NA NA NA NA ±1 NA ±1 NA NA ±1 NA ±2 ±2 ±2 ±2 ±3
±3
±7
AE/SAE Review
X----------------------------------------------------------------------------------------------------------------------X
All NSAEs and SAEs will be 
recorded up to 144-days postdose 
(inclusive). Sec. 8.4.
Laboratory 
Procedures
Serum hCG 
(WOCBP only)
X
X
X
X
Appendices 2 and 8
Serum FSH -
(WONCBP only)
X
Appendices 2, 5, and 8
HIV, Hepatitis B 
and C screen (per 
site SOP)
X
Sec. 5.2, Appendices 2 and 8
Drug and Alcohol 
Screen (per site 
SOP)
X
X
Screening and predose 
drug/alcohol screen are 
mandatory (predose drug screen 
may occur in the evening prior to 
Day 1 at the time of admission); 
any additional drug screen is 
conducted per site SOP. Sec. 
8.3.5 and Appendix 2.
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Part 2
Screening 
≤28 days 
to Day 1
Intervention
Post-
study
Notes
Scheduled Timing
(Week)
Screening 1
Screening 2a
Week 1
Week 
2
Week 
3
Week 4
Post Week 4
Scheduled Timing 
(Day)
1
2
3
4
8
10 15
17 22
23
26 29
35 42 49 63 81
111
130
Visit Window 
(Day)
NA NA NA NA NA ±1 NA ±1 NA NA ±1 NA ±2 ±2 ±2 ±2 ±3
±3
±7
24-Hour Urine 
Protein Collection 
X
The 24-hour urine collection will 
begin the evening before dosing. 
Sec. 8.3.4, Appendix 2.
24-Hour Urine 
Creatinine 
Collection
X
The 24-hour urine collection will 
begin the evening before dosing. 
Sec. 8.3.4, Appendix 2.
Spot Urine 
Collection for Urine 
Protein: Urine 
Creatinine Ratio
X
X
X
If a participant is unable to 
produce a urine sample at Day 1 
12-hours postdose, this spot urine 
can be collected the next time the 
participant is able to void. Sec. 
8.3.4, Appendix 2.
Hematology, 
Chemistry, 
Urinalysis
X
Xd
X
X
X
X
X
X
X
X
X
X
X
Hematology/Chemistry/Urinalysis 
will be obtained after an 8-hour 
fast. Days 1, 8, 15, and 22 
samples will be predose. Sec. 
8.3.5, Appendices 2 and 8.
aPTT and PT at 
local lab
X
X
X
X
X
X
X
X
X
Days 1, 8, 15, and 22 samples will 
be predose. Sec. 5.2, 8.3.5, 
Appendices 2 and 8
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Part 2
Screening 
≤28 days 
to Day 1
Intervention
Post-
study
Notes
Scheduled Timing
(Week)
Screening 1
Screening 2a
Week 1
Week 
2
Week 
3
Week 4
Post Week 4
Scheduled Timing 
(Day)
1
2
3
4
8
10 15
17 22
23
26 29
35 42 49 63 81
111
130
Visit Window 
(Day)
NA NA NA NA NA ±1 NA ±1 NA NA ±1 NA ±2 ±2 ±2 ±2 ±3
±3
±7
Hemoccult test
Xe
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Sec. 8.3.6.
Biomarkers
Blood for Genetic 
Analysisf
X
Collected predose from enrolled 
participants only. Sec. 8.8.1, 
Appendix 8
Pharmacokinetics
Blood for Plasma 
MK-2060
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Days 1, 2, 4, 8, 15, and 22 
samples will be predose. Sec. 
8.6.1, Appendix 8, and Study 
Operations Manual
Pharmacodynamics
Blood for 
PT/aPTT/FXI 
activity by central 
lab
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Days 1, 2, 4, 8, 15, and 22 
samples will be predose. Sec. 
8.7.1, Appendix 8, and Study 
Operations Manual
Blood for Plasma 
ADA
X
X
X
X
X
X
X
X
Days 1, 15 and 22 samples will be 
predose Sec. 8.7.2, Appendix 8, 
and Study Operations Manual
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Part 2
Screening 
≤28 days 
to Day 1
Intervention
Post-
study
Notes
Scheduled Timing
(Week)
Screening 1
Screening 2a
Week 1
Week 
2
Week 
3
Week 4
Post Week 4
Scheduled Timing 
(Day)
1
2
3
4
8
10 15
17 22
23
26 29
35 42 49 63 81
111
130
Visit Window 
(Day)
NA NA NA NA NA ±1 NA ±1 NA NA ±1 NA ±2 ±2 ±2 ±2 ±3
±3
±7
ADA=antidrug antibody; aPTT=activated partial thromboplastin time; AE=adverse event; BMI=body mass index; BP=blood pressure; CRU=clinical research unit; D=Day; 
DNA=deoxyribonucleic acid, ECG=electrocardiogram; FBR=future biomedical research, FSH=follicle stimulating hormone; FXI=factor XI; HIV=human immunodeficiency 
virus; hCG=human chorionic gonadotropin; HR=heart rate; ID=identification; IEC=Independent Ethics Committee; IRB=Institutional Review Board; NSAE=nonserious adverse 
event; PT=prothrombin time; RR=respiratory rate; SAE=serious adverse event; SC=subcutaneous; SOP=standard operating procedure; VS=vital signs; WOCBP=women of 
childbearing potential; WONCBP=women of nonchildbearing potential
a. Screening 2 should occur within 96 hours prior to Day 1. If Screening 1 occurs within 96 hrs prior to administration of the dose of study drug, Screening 2 is not required.
b. The poststudy visit will occur approximately 130 days following administration of study drug. Procedures outlined in the poststudy visit may obtained on Day 130 (±7 days)
Follow up on any clinical or laboratory AEs should occur in person if the poststudy visit occurs prior to 130 days following administration of study drug. If a participant 
discontinues for any reason at any time during the course of the study the participant may be asked to return to the clinic to complete the poststudy visit. The investigator may 
decide to perform the poststudy visit at the time of discontinuation or as soon as possible after discontinuation as outlined in Sections 7.1 and 8.1.9.
c. At the discretion of the investigator an in-person follow-up may be performed.
d. If Screening 2 occurs on Day -1, only obtain predose Hematology, Chemistry, Unrinalysis lab safety tests (these results will be used to satisfy both the Screening 2 and 
predose safety lab tests).
e. Hemoccult test will be provided to a participant at Screening 1 visit and returned at Screening 2 visit or prior to dosing at the time scheduled by the investigator, if Screening 2 
visit does not occur.
f. This sample should be drawn for planned analysis of the association between genetic variants in DNA and drug response. This sample will not be collected at the site if there is
either a local law or regulation prohibiting collection, or if the IRB/IEC does not approve the collection of the sample for this purpose. If the sample is collected, leftover
extracted DNA will be stored for future biomedical research once the participant signs the FBR consent. If the planned genetic analysis is not approved, but FBR is approved and
consent is given, this sample will be collected for the purpose of FBR. Blood for genetic analysis should be collected only once per participant after randomization.
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1.3.3
Part 3
Part 3
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8 12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
42 (±4 Days)
60 (±5 Days)
90 (±5 Days)
120 Poststudyb
(±5 Days)
134 Phone 
Follow-upc (±5 
Days)
Notes
Administrative 
Procedures
Informed Consent
X
Sec. 5.1, 8.1.1.1
Informed Consent for 
FBR
X
Sec. 5.1, 8.1.1.2
Inclusion/Exclusion 
Criteria
X
X
X
Sec. 5.1, 5.2, 8.1.2
Participant ID Card
X
Sec. 8.1.3
Participant ID Bracelet
X
Sec. 8.11.2
Medical History
X
X
X
Sec. 8.1.4
Assignment of 
Screening Number 
X
Sec. 8.1.6
Assignment of 
Randomization 
Number
X
The allocation number is 
assigned at the time of 
study drug 
administration. Sec. 5.5, 
8.1.7
Prior/Concomitant 
Medication Review
X------------------------------------------------------------------------------------------------------------------------------X Sec. 5.2, 6.5, 8.1.5
Safety/Clinic 
Procedures
Full physical 
examination
X
X
X
X
X
Sec. 8.3.1, 8.3.7
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Part 3
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8 12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
42 (±4 Days)
60 (±5 Days)
90 (±5 Days)
120 Poststudyb
(±5 Days)
134 Phone 
Follow-upc (±5 
Days)
Notes
Targeted physical 
examination 
X
X
Sec. 8.3.1, Sec. 8.3.7
Height
X
Sec. 8.3.1
Weight
X
X
BMI to be taken only at 
Screening 1. Sec. 8.3.1
Orthostatic VS (HR, 
BP)
X
X
X
Sec. 8.3.2.2.
Semi-recumbent VS 
(HR, BP)
X
X--------------------X
X
X
X
X
X
X
X
Day 1 measurements 
will be at predose, 1- and 
12-hours postdose. Sec. 
8.3.2
RR and body 
temperature
X
X
X
X
X
X
X
X
Sec. 8.3.2.
12-lead ECG
X
X
X
X
X
X
X
Sec. 8.3.3.
Standard Meals
X---------------X
Sec. 5.3.1.
Domiciling
X-------------------------------X
Sec. 8.1.11
MK-2060/Placebo 
Administration
X
MK-2060/Placebo will 
be administered SC at 
Time 0. Refer to Sec. 
6.2, 8.1.8 and the Study 
Pharmacy Manual for 
additional information 
on the preparation and 
administration of the 
study drug.
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Part 3
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8 12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
42 (±4 Days)
60 (±5 Days)
90 (±5 Days)
120 Poststudyb
(±5 Days)
134 Phone 
Follow-upc (±5 
Days)
Notes
Local Injection Site 
Reaction
X X X
X
X
X
X
Note: Participants who 
call the CRU to report an 
injection site reaction on 
Days 4, 5, and/or 7 may 
be asked to return to the 
CRU as soon as possible 
for an additional 
assessment. Sec. 8.3.7.
AE/SAE Review
X------------------------------------------------------------------------------------------------------------------------------X
All NSAEs and SAEs 
will be recorded up to 
104-days postdose 
(inclusive). Sec. 8.4
Laboratory 
Procedures
Serum hCG (WOCBP 
only)
X
X
X
Appendices 2 and 8
Serum FSH -
(WONCBP only)
X
Appendices 2, 5, and 8
HIV, hepatitis B and C 
screen (per site SOP)
X
Sec. 5.2, Appendices 2 
and 8
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Part 3
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8 12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
42 (±4 Days)
60 (±5 Days)
90 (±5 Days)
120 Poststudyb
(±5 Days)
134 Phone 
Follow-upc (±5 
Days)
Notes
Drug and Alcohol 
Screen (per site SOP)
X
X
Screening and predose 
drug/alcohol screen are 
mandatory (predose drug 
screen may occur in the 
evening prior to Day 1 at 
the time of admission); 
any additional 
drug/alcohol screen is 
conducted per site SOP. 
Sec. 8.3.5 and Appendix 
2
Hematology and
Chemistry
X
Xd
X
X
X
X
X
Hematology/Chemistry 
will be obtained after an 
8-hour fast. Predose tests 
can be conducted up to 
24 hours prior to dosing. 
Sec. 8.3.5, Appendices 2 
and 8
aPTT and PT at local 
lab
X
X
X
X
X
X
X
Sec. 5.2, 8.3.5, 
Appendices 2 and 8
Hemoccult test
Xe
X
X
X
X
X
X
X
X
X
X
Sec. 8.3.6 
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Part 3
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8 12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
42 (±4 Days)
60 (±5 Days)
90 (±5 Days)
120 Poststudyb
(±5 Days)
134 Phone 
Follow-upc (±5 
Days)
Notes
Biomarkers
Blood for Genetic 
Analysisf
X
Collected predose from 
enrolled participants 
only. Sec. 8.8.1, 
Appendix 8
Pharmacokinetics
Blood for Plasma MK-
2060 
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Sec. 8.6.1, Appendix 8, 
and Study Operations 
Manual
Pharmacodynamics
Blood for 
PT/aPTT/FXI activity 
by central lab
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Sec. 8.7.1, Appendix 8, 
and Study Operations 
Manual
Blood for plasma 
ADA
X
X
X
X
X
X
X
X
Sec. 8.7.2, Appendix 8, 
and Study Operations 
Manual
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Part 3
Scheduled Time
Day 1 (hours post-
dose)
Days
Scheduled Timing
Screening 1
Screening 2a
Predose
0
1
4
8 12
2 (D1 24 hrs)
3 (D1 48 hrs)
6 (D1 120 hrs)
(±1 Day)
8 (D1 168 hrs)
11 (±1 Day)
14 (±1 Day)
21 (±2 Days)
28 (±3 Days)
42 (±4 Days)
60 (±5 Days)
90 (±5 Days)
120 Poststudyb
(±5 Days)
134 Phone 
Follow-upc (±5 
Days)
Notes
ADA=antidrug antibody; aPTT=activated partial thromboplastin time; AE=adverse event; BMI=body mass index; BP=blood pressure; CRU=clinical research unit; D=Day; 
DNA=deoxyribonucleic acid, ECG=electrocardiogram; FBR=future biomedical research, FSH=follicle stimulating hormone; FXI=factor XI; HIV=human immunodeficiency 
virus; hCG=human chorionic gonadotropin; HR=heart rate; ID=identification; IEC=Independent Ethics Committee; IRB=Institutional Review Board; NSAE=nonserious adverse 
event; PT=prothrombin time; RR=respiratory rate; SAE=serious adverse event; SC=subcutaneous; SOP=standard operating procedure; VS=vital signs; WOCBP=women of 
childbearing potential; WONCBP=women of nonchildbearing potential
a. Screening 2 should occur within 96 hours prior to Day 1. If Screening 1 occurs within 96 hrs prior to administration of the dose of study drug, Screening 2 is not required.
b. The poststudy visit will occur approximately 120 days following administration of study drug. Procedures outlined in the poststudy visit may obtained on Day 120 (±5 days)
Follow up on any clinical or laboratory AEs should occur in person if the poststudy visit occurs prior to 120 days following administration of study drug. If a participant 
discontinues for any reason at any time during the course of the study the participant may be asked to return to the clinic to complete the poststudy visit. The investigator may 
decide to perform the poststudy visit at the time of discontinuation or as soon as possible after discontinuation as outlined in Sections 7.1 and 8.1.9.
c. At the discretion of the investigator an in-person follow-up may be performed.
d. If Screening 2 occurs on Day -1, only obtain predose Hematology and Chemistry lab safety tests (these results will be used to satisfy both the Screening 2 and predose safety 
lab tests).
e. Hemoccult test will be provided to a participant at Screening 1 visit and returned at Screening 2 visit or prior to dosing at the time scheduled by the investigator, if Screening 2 
visit does not occur.
f. This sample should be drawn for planned analysis of the association between genetic variants in DNA and drug response. This sample will not be collected at the site if there is
either a local law or regulation prohibiting collection, or if the IRB/IEC does not approve the collection of the sample for this purpose. If the sample is collected, leftover
extracted DNA will be stored for future biomedical research once the participant signs the FBR consent. If the planned genetic analysis is not approved, but FBR is approved and
consent is given, this sample will be collected for the purpose of FBR. Blood for genetic analysis should be collected only once per participant after randomization.
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2
INTRODUCTION
2.1
Study Rationale
Patients with CKD and ESKD have an increased prevalence of cardiovascular disease, 
including coronary artery disease, venous thrombosis, atrial fibrillation, and thromboembolic
stroke. For patients on hemodialysis, this increased risk of thrombotic events also carries a 
high rate of vascular access thrombosis, particularly in those with AVGs where it can lead to 
access failure. Anticoagulants are therefore commonly used in this patient population. 
However, these patients also have an increased risk of bleeding events, which needs to be 
balanced with the increased risk of thrombotic events using currently marketed 
anticoagulants. 
MK-2060 is an anti-FXI monoclonal antibody being developed for the prevention of 
thrombotic complications in CKD and ESKD. In contrast to most current anticoagulants, the 
use of agents that inhibit FXI are expected to reduce the risk of thrombotic events while 
having minimal effect on hemostasis. Hence, targeting FXI is an attractive option to expand 
the therapeutic window for anticoagulation in CKD and ESKD patients. The purpose of this 
study is to evaluate the safety, PK and pharmacodynamics of a single and multiple SC doses
of MK-2060 in participants with Stage 4 and Stage 5 CKD (CKD4 and CKD5), and ESKD
on peritoneal dialysis. Characterizing SC dosing in this study will help to broaden the Phase 
3 program beyond IV dosing in ESKD patients on hemodialysis, by enabling enrollment of 
CKD4, CKD5, and ESKD patients with SC injection of MK-2060.
2.2
Background
Refer to the IB for detailed background information on MK-2060.
2.2.1
Pharmaceutical and Therapeutic Background
FXI is a critical component in the intrinsic pathway of the coagulation cascade. MK-2060 is 
an anti-FXI monoclonal antibody being developed for the prevention of thrombotic events in 
CKD/ESKD. Based on preclinical and human genetic data, as well as emerging clinical data 
using an AS approach [Buller, H. R., et al 2015] [Bethune, C., et al 2017], FXI inhibition is 
predicted to confer a clinically relevant antithrombotic effect with a reduced risk of bleeding 
complications and hence an expanded therapeutic index compared to inhibition of more 
downstream clotting factors such as FXa and thrombin. Therefore, FXI/FXIa inhibition is a 
promising therapeutic approach for the prevention of thromboembolic events.
2.2.2
Completed Clinical Studies
Study MK-2060-001:
Study MK-2060-P001 was a double-blind, randomized, placebo-controlled, single site, 
sequential panel study to evaluate the safety, tolerability, PK, and pharmacodynamics of 
single ascending dose administration of SC and IV doses of MK-2060 in healthy male 
participants. Forty-five healthy male participants received single doses of MK-2060 up to 
120 mg administered SC (27 participants) or 40 mg IV (18 participants). MK-2060 was 
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generally well tolerated and there were no SAEs or discontinuations due to AEs. In healthy 
male participants single IV doses of 20 mg and 40 mg of MK-2060 resulted in increases in 
aPTT 
 baseline within 1 hour of administration (
 FXI activity inhibition), with aPTT 
remaining 
 baseline for 
 hours. 
MK-2060-004:
MK-2060-004 was a 2-part, double-blind, randomized, placebo-controlled, multiple-site, 
sequential-panel, single and multiple dose study in adult male and female ESKD participants 
on hemodialysis. The study evaluated the safety, PK and pharmacodynamics of IV 
administration of single-dose (8, 20 or 40 mg) and multiple dose (25-mg loading dose 
followed by QW dosing for 3 weeks) MK-2060. A total of 38 participants were enrolled. 
Single doses up to 40-mg and multiple 25-mg doses were generally well tolerated. Two 
participants discontinued the study due to a drug-related SAE of lower GI hemorrhage 
(placebo) and nondrug-related AE of COVID-19 infection. A total of 4 SAEs (myocardial 
infarction, GI hemorrhage, pneumonia, and AV graft thrombosis) were reported in 4 
participants (n=1 in MK-2060 group and n=3 placebo group, respectively). The investigator 
deemed the myocardial infarction as not related to study intervention as the event occurred 
approximately 11 weeks after the last dose of MK-2060. Intervention-related AEs reported in 
participants who received MK-2060 included orthostatic hypotension, headache, 
chromaturia, hematuria, AV fistula hemorrhage, sneezing, and nausea. Anti-drug antibody 
assessment was positive in 2 participants of which neither participant reported AEs after 
showing a positive response to MK-2060.
PK data following single and multiple doses showed a t1/2 ranging from 
 days with 
a median observed Tmax of about 
 following infusion of MK-2060. Observed GM 
Cmax of single dose MK-2060 at 8, 20, and 40 mg was 
, 
respectively. Observed Cmax following multiple dose MK-2060 was 
.
Multiple-dose MK-2060 25 mg showed aPTT prolongation with a maximum mean fold-
change of 
. Overall, no effect on PT was observed.
MK-2060-008:
MK-2060-008 was a Phase 1, open-label, multi-site multiple-dose study to evaluate the 
safety and tolerability of coadministered IV MK-2060 and clopidogrel in adult (male and 
female) participants with ESKD on HD. Following a 14-day run in period, participant on 
clopidogrel therapy received a loading dose of 25 mg IV of MK-2060 for a total of 3 doses in 
Week 1 and a single dose of 25 mg IV MK-2060 in Week 2. 12 participants were enrolled in 
MK-2060, which was generally well tolerated when coadministered with clopidogrel. There 
were no bleeding related AEs in the study and there was not a significant difference in time 
to hemostasis following hemodialysis when clopidogrel was administered with or without 
concomitant administration of MK-2060. Clodipogrel was not shown to impact the PK 
profile of MK-2060.
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
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2.2.3
Ongoing Clinical Studies
MK-2060-007:
MK-2060-007 is an event driven, randomized, placebo-controlled, parallel-group, multi-site, 
double-blind study of MK-2060 in participants with ESKD receiving hemodialysis via an 
AVG. This Phase 2 study is designed to evaluate the efficacy and safety of MK-2060 20 mg 
QW and MK-2060 6 mg QW (with 3 loading doses in Week 1). As of 10-Sep-2023, 506 
participants have been randomized in MK-2060-007 and 502 have been dosed with a 
maximum exposure of 687 days. MK-2060-007 is ongoing and safety data are blinded and 
preliminary.
MK-2060-009:
This is a Phase 1 randomized, placebo-controlled, single-ascending dose clinical study to 
evaluate the safety, PK, and pharmacodynamics of IV MK-2060 in healthy Chinese male 
adult participants. As of 10-Sep-2023, 3 panels of 12 participants each (9 MK-2060: 3 
placebo) were administered single 8 mg, 20 mg, and 40 mg IV doses of MK-2060 or placebo 
(9:3). Twenty-four (24) participants in Panel A-B have completed their last visit and all 
assessments. The estimated LPLV is 28-Oct-2023.
MK-2060-012:
This is a Phase 1 randomized, placebo-controlled single-dose clinical study to evaluate the 
safety, tolerability, PK, and pharmacodynamics of IV MK-2060 in Japanese older 
participants with end-stage kidney disease on dialysis. As of 10-Sep-2023, 17participants 
were administered a single 50 mg IV dose of MK or placebo (3:1 ratio). LPI was achieved 
with estimated LPLV 07-Feb-2024.
MK-2060-013
This is a randomized, placebo-controlled, single-ascending dose clinical study to evaluate 
safety, tolerability, PK and pharmacodynamics of MK-2060 in healthy Japanese adult 
participants. As of 10-Sep-2023, 4 panels of 12 participants each (3:1 ratio) were 
administered single 8 mg, 20 mg, and 50 mg IV doses of MK-2060, and 30 mg SC dose of 
MK-2060, or placebo (3:1 ratio). LPLV: is estimated 18-Dec-2023
2.3
Benefit/Risk Assessment
Participants in clinical studies will not receive direct benefit from treatment during 
participation as clinical studies are designed to provide information about the safety and 
properties of an investigational medicine. 
Additional details regarding specific benefits and risks for participants participating in this 
clinical study may be found in the accompanying IB and informed consent documents.
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3
HYPOTHESES, OBJECTIVES, AND ENDPOINTS
Hypotheses are aligned with objectives in the Objectives and Endpoints table.
This study is to be conducted in adult participants with chronic and/or end-stage kidney 
disease.
Primary Objectives
Primary Endpoints
Part 1: To evaluate the safety and 
tolerability of MK-2060 following single-
dose SC administration in adult participants 
with Stage 4 or 5 Chronic Kidney Disease.
Part 2: To evaluate the safety and 
tolerability of MK-2060 following multiple-
dose SC administration in adult participants 
with Stage 4 or 5 Chronic Kidney Disease.
Part 3: To evaluate the safety and 
tolerability of MK-2060 following single-
dose SC administration in adult participants 
with End-Stage Kidney Disease on 
Peritoneal Dialysis.
Bleeding related AEs, AEs, and 
discontinuations due to AEs
Part 1: To evaluate plasma 
pharmacokinetics of MK-2060 following 
single-dose SC administration in adult 
participants with Stage 4 or 5 Chronic 
Kidney Disease.
Hypothesis:
The true geometric mean of AUC0-∞ after a 
single well tolerated dose of MK-2060 in 
adult participants with Stage 4 or 5 Chronic 
Kidney Disease is at least 11300 nM*hr.
Part 2: To evaluate plasma 
pharmacokinetics of MK-2060 following 
multiple-dose SC administration in adult 
participants with Stage 4 or 5 Chronic 
Kidney Disease.
Estimation:
The effect of multiple-dose SC 
administration of MK-2060 in adult 
participants with Stage 4 or 5 Chronic 
Kidney Disease will be estimated.
Measurement of MK-2060 plasma AUC0-
∞, AUC0-168, Cmax, C168, Tmax,
terminal t1/2, CL/F and Vz/F
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Part 3: To evaluate plasma 
pharmacokinetics of MK-2060 following 
single-dose SC administration in adult 
participants with End-Stage Kidney Disease 
on Peritoneal Dialysis.
Estimation:
The effect of single-dose SC administration 
of MK-2060 in adult participants with End 
Stage Kidney Disease on Peritoneal 
Dialysis will be estimated.
Secondary Objective
Secondary Endpoint
Part 1: To evaluate the effect of MK-2060 
on aPTT following single dose SC 
administration in adult participants with 
Stage 4 or 5 Chronic Kidney Disease.
Part 2: To evaluate the effect of MK-2060 
on aPTT following multiple-dose SC 
administration in adult participants with 
Stage 4 or 5 Chronic Kidney Disease.
Part 3: To evaluate the effect of MK-2060 
on aPTT following single dose SC 
administration in adult participants with 
End-Stage Kidney Disease on Peritoneal 
Dialysis.
aPTT fold change from baseline
Tertiary/Exploratory Objectives
Tertiary/Exploratory Endpoints
Parts 1 and 3: To explore the effect of MK-
2060 on Factor XI (FXI) activity levels 
following a single SC dose.
Part 2: To explore the effect of MK-2060 on 
Factor XI (FXI) activity levels following 
multiple SC doses.
FXI activity level fold change from baseline
Parts 1 and 3: To explore the effect of MK-
2060 on prothrombin time (PT) following a 
single SC dose.
Part 2: To explore the effect of MK-2060 on 
prothrombin time (PT) following multiple
SC doses.
PT fold change from baseline
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To explore the relationship between genetic 
variation and response to the treatment(s) 
administered, and mechanisms of disease. 
Variation across the human genome may be 
analyzed for association with clinical data 
collected in this study.
Germline genetic variation and association 
to clinical data collected in this study
To explore the development and impact of 
ADAs measured in blood samples after
single and multiple SC doses of MK-2060 is 
administered in adult participants with 
Chronic and/or End-Stage Kidney Disease.
ADAs
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4
STUDY DESIGN
4.1
Overall Design
This is a 3-part, multi-site, randomized, double-blind, placebo-controlled, single-dose and 
multiple-dose study to assess the safety, tolerability, PK and pharmacodynamics of SC MK-
2060 in participants with CKD4, CKD5, and ESKD on Peritoneal Dialysis.
In Part 1, participants with CKD4 or CKD5 (eGFR from 10 to 29) (n=12) will be randomized 
in a 3:1 ratio to receive a single 30-mg SC dose of MK-2060 (n=9) or placebo (n=3). 
In Part 2, participants with CKD4 or CKD5 (n= 12) will be randomized in a 3:1 ratio to 
receive 4 loading doses of 30 mg SC MK-2060 or placebo (given daily for 4 days) followed 
by 30 mg SC MK-2060 (n=9) or placebo (n=3) every week for 3 additional weeks. A 
minimum of 4 participants with CKD5 will be enrolled in the study, of which a minimum of 
3 will receive MK-2060. 
Participants who successfully completed Part 1 through the post study visit may enroll in 
Part 2 provided screening criteria are met.
In Part 3, an open label study, participants with ESKD who are on peritoneal dialysis will 
receive a single 30 mg SC dose of MK-2060 (n=9).
In all 3 parts, participants will be closely monitored for safety and tolerability, including 
safety labs, local lab aPTT and PT results, physical exam to check incidence of bleeding, VS 
and 12-lead ECG, as well as local injection site reactions and for systemic reactions.
The study design is depicted in Figure 1, Figure 2, and Figure 3. Part 2 and Part 3 can be 
completed in parallel. For all participants, blood samples will be collected for MK-2060 
plasma PK and pharmacodynamics. The precise timing of safety and tolerability 
measurements, PK and pharmacodynamics samples may be altered during the course of the 
study based on newly available data.
Because this is a Phase 1 assessment of MK-2060 in humans, the PK, pharmacodynamic, and 
safety profiles of the compound are still being elucidated. This protocol is therefore written 
with flexibility to accommodate the inherent dynamic nature of Phase 1 clinical studies. 
Refer to Section 8.11.7 for examples of modifications permitted within the protocol 
parameters.
Specific procedures to be performed during the study, including prescribed times and 
associated visit windows, are outlined in Section 1.3 of the SoA. Details of each procedure 
are provided in Section 8.
4.2
Scientific Rationale for Study Design
To date, the safety and tolerability of MK-2060 have been evaluated in healthy participants 
dosed both via SC and IV administration (P001), and in ESKD-HD participants with IV 
dosing (P004 and P008). Ongoing Phase 1 studies are assessing safety and tolerability of IV
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doses of MK-2060 in healthy Chinese and Japanese participants (P009 and P013), IV doses 
in Japanese dialysis patients (P012), and SC doses in healthy Japanese participants (P013).
An ongoing Phase 2b study (P007) is evaluating the safety and efficacy of MK-2060 in 
ESKD-HD patients using IV dosing. The highest IV dose tested in the Phase 2b study is 
20 mg IV. Because severe CKD patients not yet on dialysis (ie, CKD4, CKD5) may also 
derive a benefit from inhibition of FXI, enrollment of these patients in a Phase 3 study is 
warranted. In Phase 3, MK-2060 will be dosed IV in ESKD-HD patients due to the simplicity 
of IV administration during hemodialysis sessions. However, dosing in CKD4 and CKD5 
patients not yet on dialysis will require SC administration, and SC PK has not yet been 
characterized in these patients. For patients with ESKD on peritoneal dialysis, IV 
administration is not practical, and enrollment of this patient population in Phase 3 requires 
an assessment of safety and PK of SC doses of MK-2060 in ESKD. Globally, approximately 
11% of ESKD patients use peritoneal dialysis, with higher rates of utilization in some regions
and therefore it is important to include this population so that they can also be candidates for 
MK-2060 therapy. Therefore, the purpose of this study is to characterize the SC PK of MK-
2060 in CKD4, CKD5, and ESKD-Peritoneal Dialysis patients using single and multiple 
doses, in order to help provide information to guide dose selection for future clinical studies. 
Part 1 of this study will test the hypothesis that a single 30 mg SC dose of MK-2060 in 
CKD4 patients will achieve exposures such that if multiple doses were given and steady state 
exposures were achieved, our pharmacodynamics target 
 
 would be projected to be achieved, within the predicted degree of 
interindividual PK variability. The AUC0-∞ for a single 30 mg SC dose in CKD4 patients is 
projected to be 11300 nM*hr with 30% GCV. These numbers are based on estimated 
bioavailability 
 and other PK parameters using data from SC dosing of MK-2060 in 
P001 (NHV) and P004 (ESKD-HD patients). In Part 2, preliminary analysis of PK and 
pharmacodynamic data from Part 1 supports a 30 mg SC dose of MK-2060 to be given as a 
loading dose for 4 consecutive days, followed by QW doses for 3 weeks. The predicted mean 
Cmax after last dose of 30-mg SC dose of MK-2060 is 
. In Part 3, a single 30 mg SC 
dose of MK-2060 is proposed based on emerging data from Part 1 and to enable a direct 
comparison of PK for this dose between CKD4/CKD5 and dialysis patients and the single 30 
mg SC dose given to Japanese NHVs in P013. PK parameters will be estimated for Parts 2 
and 3 and SC dose projection will be further modified based on emerging data.
4.2.1
Rationale for Endpoints
4.2.1.1
Safety Endpoints
Based on the data from P001 (healthy participant study), P004 (ESKD on HD study), P008 
(ESKD on HD coadministered with Clopidogrel), and P007 (ongoing Phase 2 study in ESKD
on HD with AVG) along with preclinical safety data, it is expected that single dose SC 
administration of MK-2060 will be well-tolerated in participants with CKD and ESKD. 
Physical examinations, VS, ECGs, laboratory safety tests (serum chemistry and hematology), 
aPTT, PT, and AEs related to bleeding will be assessed throughout the treatment period. 
AEs, including local infusion site reactions and systemic reactions to MK-2060 infusion, will 
be assessed throughout the treatment period.
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Bleeding related AEs will include any sign or symptom of bleeding, even if not requiring 
intervention by a medical/healthcare professional, as well as clinically relevant nonmajor 
bleeding or major bleeding. As with all biologic medications, MK-2060 carries a risk of 
acute reactions upon exposure. These reactions can be categorized as common injection 
reactions, hypersensitivity reactions, and high cytokine release reactions. Acute reactions are 
usually mild, can occur even with the first dose, and can manifest with rigors, back pain, 
abdominal pain, nausea, vomiting, diarrhea, dyspnea, flushing, pruritus, and changes in heart 
rate or blood pressure. Acute hypersensitivity reactions typically occur after repeated 
exposures but can occur with the first dose. In addition to signs similar to common infusion 
reactions, participants may develop urticaria, wheezing, coughing, facial swelling, 
angioedema and more significant changes in VS. Cytokine release reactions are exceedingly 
rare but severe. They manifest as severe headache, nausea, vomiting, back pain, fever, 
hypotension and multiorgan failure. The risk of any of these reactions to MK-2060 is 
considered low given its profile in preclinical safety studies. There were no infusion 
reactions, no acute hypersensitivity reactions, and no cytokine release reactions observed 
thus far in any MK-2060 clinical studies. See the IB for more information on the Phase 1 
clinical study experience with MK-2060.
Anti-drug antibodies to MK-2060
The presence and titer of ADAs may be measured using validated assays. ADAs can develop 
to biologics like MK-2060. ADAs may be clinically inconsequential or may change the PK 
and/or drug efficacy. Moreover, ADAs may lead to safety events, such as acute or delayed 
hypersensitivity reactions. Thus, the titer of ADAs will be correlated with PK and safety 
events.
4.2.1.2
Pharmacokinetic Endpoints
Plasma PK of MK-2060
In order to characterize the PK profile of MK-2060 PK in adults with CKD and ESKD,
noncompartmental PK parameters including AUC0-∞, AUC0-168, Cmax, C168, Tmax, 
terminal t1/2, CL/F, and Vz/F will be summarized after single- and multiple-dose SC 
administration.
4.2.1.3
Pharmacodynamic Endpoints
aPTT, PT and FXI activity (performed by Central Lab)
In order to assess pharmacodynamics, this study will include an assessment of aPTT 
prolongation levels (relative to baseline), PT and FXI activity levels, with assays performed 
at a Central Laboratory. For PK/pharmacodynamics modeling, aPTT and FXI activity levels 
will be related to plasma exposure. The time points for pharmacodynamics data collection are 
based on the projected PK profile of MK-2060. PK and pharmacodynamics measurements 
will allow comparison to PK/pharmacodynamics modeling targets at steady state.
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4.2.1.4
Planned Exploratory Biomarker Research
4.2.1.4.1
Planned Genetic Analysis
Genetic variation may impact a participant’s response to therapy, susceptibility to, severity, 
and progression of disease. Variable response to therapy may be due to genetic determinants 
that impact drug ADME; mechanism of action of the drug; disease etiology; and/or 
molecular subtype of the disease being treated. Therefore, where local regulations and 
IRB/IEC allow, a sample will be collected for DNA analysis from consenting participants.
DNA samples may be used for research related to the study intervention(s), the disease under 
study, or related diseases. They may also be used to develop tests/assays including diagnostic 
tests related to the disease under study, related diseases, and study intervention(s). Genetic 
research may consist of the analysis of 1 or more candidate genes, the analysis of genetic 
markers throughout the genome, or analysis of the entire genome. Analysis may be 
conducted if it is hypothesized that this may help further understand the clinical data.
The samples may be analyzed as part of a multistudy assessment of genetic factors involved 
in the response to understand study disease or related conditions.
4.2.1.5
Future Biomedical Research
The Sponsor will conduct FBR on DNA specimens for which consent was provided during 
this clinical study.
Such research is for biomarker testing to address emergent questions not described elsewhere 
in the protocol and will only be conducted on specimens from appropriately consented 
participants. The objective of collecting/retaining specimens for FBR is to explore and 
identify biomarkers that inform the scientific understanding of diseases and/or their 
therapeutic treatments. The overarching goal is to use such information to develop safer, 
more effective drugs/vaccines, and/or to ensure participants receive the correct dose of the 
correct drug/vaccine at the correct time. The details of FBR are presented in Appendix 6.
4.2.2
Rationale for the Use of Placebo
A primary goal of this study is to evaluate the safety and tolerability of a single and multiple 
SC doses of MK-2060 in adult participants with chronic kidney disease and ESKD. A 
placebo-controlled study for single and multiple doses of MK-2060 will allow for an 
unbiased assessment of safety and tolerability of MK-2060, including local injection site 
reactions. In the single SC dose panel in participants with ESKD on peritoneal dialysis, an 
open label study design will be used based on cumulative safety and tolerability of MK-2060 
in the ESKD on HD population.
4.3
Justification for Dose
As this is a Phase 1 assessment of MK-2060 in humans, and the PK, pharmacodynamic and 
safety profiles of the compound are still being evaluated, modifications to the dose or dosing 
regimen may be required to achieve the scientific goals of the study objectives and/or to 
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ensure appropriate safety monitoring of the study participants. Details of allowed 
modifications are provided in Section 8.11.6.
For Part 1, the 30-mg single SC dose was selected, because, from preliminary modeling and 
simulation analysis, this dose is anticipated to provide a maintenance level of aPTT 
prolongation 
 at steady state via QW SC dosing in at least 
 of CKD4 patients. The 
30-mg single SC dose of MK-2060 is anticipated to result in a geometric mean Cmax of 
approximately 
 and AUC0-∞ of 11300 nM*hr. These numbers are based upon 
preliminary population PK modeling of observed PK of single SC doses in P001 and 
observed PK in ESKD-HD participants in P004. The projected exposures assume a 
bioavailability observed in SC dosing of MK-2060 in P001 NHV (SC/IV GMR for AUC0-∞ 
and AUC0-last were 
, respectively), and a t1/2 observed in ESKD-HD patients 
after IV administration (P004, 
).
These exposures are significantly lower than the chronic toxicology NOAEL (Cmax 
approximately 
, AUC0-168 = 
 from the 4-week rhesus monkey 
toxicity study at 60 mg/kg/week). In P004 (Part 2), where ESKD-HD patients received 
multiple QW 25-mg doses of MK-2060, the observed geometric mean steady state Cmax and 
AUC0-168 was approximately 
 and 
, respectively, and MK-2060 was 
generally well tolerated.
In Part 2, preliminary analysis of PK and pharmacodynamic data from Part 1 supports a 30 
mg SC dose of MK-2060 to be given as a loading dose for 4 consecutive days, followed by 
QW doses for 3 weeks. This dosing regimen is anticipated to achieve aPTT prolongation 
 from start of treatment which can be maintained at steady state via QW 
SC dosing in at least 
 of CKD4 and CKD5 patients. The predicted mean Cmax after last 
dose of 30-mg SC dose of MK-2060 is 
. As this dose projection is based on 
preliminary data from Part 1 together with data from other Phase 1 studies, the dose used 
may be modified based on additional data.
In Part 3, a single 30 mg SC dose of MK-2060 is proposed based on emerging data from Part 
1 and to enable a direct comparison of PK for this dose between CKD4/CKD5 and dialysis 
patients and the single 30 mg SC dose given to Japanese NHVs in P013.
4.4
Beginning and End-of-Study Definition
The overall study begins when the first participant (or their legally acceptable representative) 
provides documented informed consent. The overall study ends when the last participant 
completes the last study-related contact, withdraws consent, or is lost to follow-up (Section 
7.3). For purposes of analysis and reporting, the overall study ends when the Sponsor 
receives the last laboratory test result or at the time of final contact with the last participant, 
whichever comes last.
If the study includes countries in the European Economic Area (EEA), the local start of the 
study in the EEA is defined as First Site Ready (FSR) in any Member State.
A study may be paused during review of newly available preclinical/clinical safety, PK, 
pharmacodynamic, efficacy, or biologic data or other items of interest, prior to a final 
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decision on continuation or termination of the study. It may be necessary to keep the study 
open for gathering/reviewing of additional supportive data to optimally complete the 
objective(s) of the study. If necessary, the appropriate amendment(s) to the protocol and/or 
appropriate communication(s) will be generated. If the decision has been made to end the 
study following this review period, the study end will be defined as the date of the Sponsor 
decision, and this end of study date supersedes the definitions outlined above. The 
Competent Authority(ies) and IRB(s)/IEC(s) will be apprised of the maximum duration of 
the study beyond the last participant out and the justification for keeping the study open.
4.4.1
Clinical Criteria for Early Study Termination
There are no prespecified criteria for terminating the study early. A primary objective of this 
early Phase 1 study is to identify a safe and well-tolerated dose and/or dosing regimen that 
achieve PK, pharmacodynamic, and/or biologic targets in humans based on preclinical or 
early clinical data. Therefore, it is possible that study participants may not receive all doses 
specified in the protocol if this objective is achieved at lesser dose levels in this study. This 
would not be defined as early termination of the study, but rather an earlier than anticipated 
achievement of the study objective(s). If a finding (eg, PK, pharmacodynamic, efficacy, 
biologic targets, etc) from another preclinical or clinical study using the study intervention(s), 
comparator(s), drug(s) of the same class, or methodology(ies) used in this study results in the 
study(ies) or program being stopped for nonsafety reasons, this also does not meet the 
definition of early study termination.
Early study termination is defined as a permanent discontinuation of the study due to 
unanticipated concerns of safety to the study participants arising from clinical or preclinical 
studies with the study intervention(s), comparator(s), drug(s) of the same class, or 
methodology(ies) used in this study.
The clinical study may be terminated early if the extent (incidence and/or severity) of 
emerging effects/clinical endpoints is such that the risk/benefit ratio to the study population 
as a whole is unacceptable. In addition, further recruitment in the study or at (a) particular 
study site(s) may be stopped due to insufficient compliance with the protocol, GCP, and/or 
other applicable regulatory requirements, procedure-related problems or the number of 
discontinuations for administrative reasons is too high.
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5
STUDY POPULATION
As stated in the Code of Conduct for Clinical Trials (Appendix 1.1), this study includes 
participants of varying age (as applicable), race, ethnicity, and sex (as applicable). The 
collection and use of these demographic data will follow all local laws and participant 
confidentiality guidelines while supporting the study of the disease, its related factors, and 
the IMP under investigation.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1
Inclusion Criteria
An individual is eligible for inclusion in the study if the individual meets all of the following 
criteria:
Type of Participant and Disease Characteristics
1. At the time of screening, the participant has CKD 4 or 5 (Parts 1 and 2), or ESKD on 
Peritoneal Dialysis (Part 3). with a baseline estimated eGFR of 10 to 29 mL/min/1.73 m2
based on the 2021 CKD-EPI Equation (Parts 1 and 2). CDK4 is defined as an eGFR from 
15 to 29 mL/min/1.73 m2. While CKD5 is defined as eGFR <15, not on dialysis, only 
CKD5 participants with an eGFR from 10 to 14 mL/min/1.73 m2 will be enrolled as these 
patients are likely to be more stable than those with eGFR<10 and less likely to transition 
to dialysis during the time frame of the study.
CKD-EPI Equation:
eGFRcr = 142 x min(Scr/κ, 1)α x max(Scr/κ, 1)-1.200 x 0.9938Age x 1.012 [if female]
where:
Scr = standardized serum creatinine in mg/dL
κ = 0.7 (females) or 0.9 (males)
α = -0.241 (female) or -0.302 (male)
min(Scr/κ, 1) is the minimum of Scr/κ or 1.0
max(Scr/κ, 1) is the maximum of Scr/κ or 1.0
Age (years)
Baseline eGFR will be obtained twice (at least 72 hours apart as a part of participant 
screening), and the mean of the two values will be used. The 2 values used should not differ 
by more than 30%. The second baseline eGFR may be obtained at the time of check in. 
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At the discretion of the investigator each baseline eGFR measurement may be repeated once
and a measured CrCl, as determined by a 24-hour urine collection, may be used in place of, 
or in conjunction with, the estimate of the eGFR.
2. The participant has a BMI ≥18 and ≤45 kg/m2. See Section 8.3.1.2 for criteria on 
rounding to the nearest whole number. BMI=weight (kg)/height (m)2.
3. Baseline health of the participant is judged to be stable based on medical history, physical 
examination, vital sign measurements, and ECGs performed prior to 
randomization/allocation.
4. The participant has liver function test (ALT and AST) results equal to or below 1.5x 
ULN and deemed not clinically significant by both the investigator and the Sponsor.
Demographics
5. The participant is male or female, from 18 years to 80 years of age inclusive, at the time 
of providing informed consent.
Female Participants
6. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 
at least one of the following conditions applies:
•
Not a WOCBP
OR
•
A WOCBP and:
-
Uses an acceptable contraceptive method, or be abstinent from heterosexual 
intercourse as their preferred and usual lifestyle (abstinent on a long-term and 
persistent basis), as described in Appendix 5 during the intervention period and for at 
least 96 days after the last dose of study intervention. The investigator should 
evaluate the potential for contraceptive method failure (ie, noncompliance, recently 
initiated) in relationship to the first dose of study intervention. Contraceptive use by 
women should be consistent with local regulations regarding the methods of 
contraception for those participating in clinical studies.
-
Has a negative highly sensitive pregnancy test (serum as required by local 
regulations) within 76 hours before the first dose of study intervention. Additional 
requirements for pregnancy testing during and after study intervention are in Section 
8.3.5.
-
Medical history, menstrual history, and recent sexual activity has been reviewed by 
the investigator to decrease the risk for inclusion of a woman with an early undetected 
pregnancy.
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Informed Consent
7. The participant has provided documented informed consent for the study. The participant 
may also provide consent for FBR. However, the participant may participate in the study 
without participating in FBR.
Consent must be documented by the participant’s dated signature dated signature on a 
consent form along with the dated signature of the person conducting the consent discussion.
A copy of the signed and dated consent form should be given to the participant before 
participation in the study.
The initial informed consent form, any subsequent revised written informed consent form 
and any written information provided to the participant must receive the IRB/ERC’s 
approval/favorable opinion in advance of use. The participant should be informed in a timely 
manner if new information becomes available that may be relevant to the participant’s 
willingness to continue participation in the study. The communication of this information 
will be provided and documented via a revised consent form or addendum to the original 
consent form that captures the participant’s dated signature dated signature.
Specifics about a study and the study population will be added to the consent form template 
at the protocol level.
The informed consent will adhere to IRB/IEC requirements, applicable laws and regulations 
and Sponsor requirements.
5.2
Exclusion Criteria
An individual must be excluded from the study if the individual meets any of the following 
criteria:
Medical Conditions
1. The participant has a history of clinically significant concomitant disease or condition 
(including treatment for such conditions) or diseases whose current condition is 
considered clinically unstable (with the exception of stable CKD) that, in the opinion of 
the investigator, could either interfere with the study drug, compromise interpretation of 
study data, or pose an unacceptable risk to the patient. Participants with a remote history 
of uncomplicated medical events (eg, childhood asthma) may be enrolled in the study at 
the discretion of the investigator.
2. The participant has rapidly fluctuating renal function as determined by historical 
measurements. Rapidly fluctuating renal function is defined as > 30% difference between 
2 measurements of eGFR taken at least 72 hours apart as part of subject screening.
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3. The participant is mentally or legally incapacitated, has significant emotional problems at 
the time of pre-study (screening) visit or expected during the conduct of the study or has 
a history of clinically significant psychiatric disorder of the last 5 years. Participants who 
have had situational depression may be enrolled in the study at the discretion of the 
investigator.
4. The participant has a history of cancer (malignancy), including adenocarcinoma.
Exceptions: (1) Participants with adequately treated non-melanomatous skin carcinoma may 
participate in the study; or carcinoma in situ of the cervix or; (2) Participants with other  
malignancies which have been successfully treated ≥ 5 years prior to the prestudy (screening) 
visit where, in the judgement of both the investigator and treating physician, appropriate 
follow-up has revealed no evidence of recurrence from the time of treatment through the time 
of the prestudy (screening) visit; or (3) Participants, who, in the opinion of the study 
investigator, are highly unlikely to sustain a recurrence for the duration of the study
5. The participant has blood coagulation test (aPTT, PT) ≥20 % outside of normal range on 
prestudy (Screening), which are considered clinically significant by both the investigator 
and the Sponsor.
6. The participant has any other clinically significant abnormalities in laboratory test results 
at screening that would, in the opinion of the investigator, increase the participant’s risk 
of participation, jeopardize complete participation in the study, or compromise 
interpretation of study data.
7. The participant has a history of deep vein thrombosis or pulmonary embolism. Has a 
history of vascular access thrombosis within 1 month prior to enrollment. Has a personal 
or family history of bleeding disorder (eg, hemophilia, Factor V Leiden, prothrombin 
gene mutation, protein C or S deficiency, ATIII deficiency, anti-phospholipid Ab 
syndrome).
8. The participant has a history of GI bleeding, duodenal polyps or gastric ulcer in the last 5 
years or severe hemorrhoidal bleed in the last 3 months.
9. The participant has a history of or current frequent epistaxis within the last 3 months or 
active gingivitis.
10. The participant has ongoing anticoagulant therapy (warfarin, apixaban, dabigatran, 
rivaroxaban, edoxaban, betrixaban) or antiplatelet therapy (prasugrel, ticagrelor, 
ticlopidine). Aspirin and clopidogrel are permitted.
11. At the time of screening or pre-dose, the participant has planned significant dental 
procedures (including planned dental surgery), or other planned surgical procedures 
within duration of participation of study.
12. The participant is positive for hepatitis B surface antigen or HIV. Participants positive for 
hepatitis C antibodies may be enrolled with agreement of both investigator and sponsor. 
Positive test(s) for HBsAg, hepatitis C antibodies or HIV.
13. The participant had a major surgery and/or donated or lost 1 unit of blood (approximately 
500 mL) within 4 weeks prior to the pre-study (screening) visit.
14. The participant has a history of significant multiple and/or severe allergies (e.g., food, 
drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e., 
systemic allergic reaction) to prescription or non-prescription drugs or food.
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15. The participant has a tattoo, scar, or other physical finding at the area of the injection that 
would interfere with the injection or a local tolerability assessment.
16. The participant has a history (participant recall) of receiving any human immunoglobulin 
preparation such as IVIG or RhoGAM within the last year.
17. The participant has a history (participant recall) of receiving any biological therapy 
(including human blood products or monoclonal antibodies; excluding erythropoietin and 
insulin) within the last 3 months or 5 half-lives (whichever is longer), or vaccination 
within the last 1 month.
Exceptions:
•
Participants who have received seasonal flu vaccine and pneumococcal vaccine within 
the last 1 month may be enrolled at the discretion of the investigator.
•
COVID-19 vaccine may be administered. The study intervention must be given at least 
72 hours following or at least 48 hours prior to any COVID-19 vaccination. 
Investigational COVID-19 vaccines (ie, those not licensed or approved for Emergency 
Use) are not allowed.
18. Exclusion criteria for ECG:
•
Heart rate <40 or >110 bpm
•
QTc interval >500 msec
•
Any significant arrhythmia or conduction abnormality, (including but not specific to 
atrioventricular block [2nd degree or higher], Wolff Parkinson White syndrome [unless 
curative radio ablation therapy]), which, in the opinion of the investigator and sponsor,
could interfere with the safety for the individual patient.
Prior/Concomitant Therapy
19. The participant is unable to refrain from or anticipates the use of any medication, 
including prescription and nonprescription drugs or herbal remedies beginning 
approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study 
intervention, throughout the study (including washout intervals between treatment 
periods), until the poststudy visit. There may be certain medications that are permitted to 
treat chronic conditions and/or conditions associated with kidney disease if the 
participant has been on a stable regimen for approximately 2 weeks prior to study drug 
administration. All efforts should be made to inject other injectable medications (ie, 
insulin, GLP-1 analogs) for which the participant has been on a stable regimen in a 
location other than where the study medication/placebo is injected (see Section 6.5).
Prior/Concurrent Clinical Study Experience
20. The participant has been in another investigational study within 4 weeks (or 5 half-lives, 
whichever is greater) prior to the sponsor’s investigational drug (MK-2060) 
administration. The window will be derived from the date of the last dose in the previous 
study.
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Diagnostic Assessments
21. The participant has a BP >190 mmHg systolic or >110 mmHg diastolic.
Other Exclusions
22. The participant is under the age of legal consent.
23. The participant consumes greater than 3 servings of alcoholic beverages (1 serving is 
approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or 
distilled spirits [29.5 mL/1 ounce]) per day. Participants who consume 4 servings of 
alcoholic beverages per day may be enrolled at the discretion of the investigator.
24. The participant consumes excessive amounts, defined as greater than 6 servings (1 
serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy 
drinks, or other caffeinated beverages per day.
25. The participant is a regular user of any illicit drugs or has a history of drug (including 
alcohol) abuse within approximately 2 years. Participants must have a negative serum or 
saliva drug screen prior to randomization. Participants with a positive drug screen due to 
the use of physician prescribed medications (eg, opioids, benzodiazepines,
antidepressants) may be enrolled at the discretion of the investigator. In addition, 
participants with a positive THC may be enrolled at the discretion of the investigator if 
the participants’ THC use is under 4 times/month and the participants agree to not use 
during their study participation. Participants with positive THC on screening may have 
rechecks performed at the discretion of the investigator to ensure compliance with 
abstinence from THC use during study participation.
26. The participant is unwilling to comply with the study restrictions (see Section 5.3 for a 
complete summary of study restrictions).
27. The investigator has any concern regarding safe participation in the study or for any other 
reason the investigator considers the participant inappropriate for participation in the 
study.
28. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or 
child) who is investigational site or Sponsor staff directly involved with this study.
5.3
Lifestyle Considerations
5.3.1
Meals and Dietary Restrictions
Fasting requirements for study procedures, such as, but not limited to, laboratory safety 
evaluations are specified in Section 8.
All meals on the study day of dosing will be served as to not interfere with the study 
procedures.
On day of dosing, participants will fast from all food and drinks, except water, for at least 8 
hours prior to study drug administration. Participants will continue to fast until 2 hours after 
study drug/placebo administration when they will be given breakfast. Breakfast will be 
administered approximately 2 hours post-dose; lunch and dinner will be provided at ~ 4- and 
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~ 10-hours postdose respectively. Additional meals and snack(s) will be provided by the 
investigator as per the CRUs standard procedures. Participants will fast from all food and 
drinks, except water, between meals and snacks. After the 24-hour postdose procedures on 
the day of dosing have been completed, subsequent meals and snacks will be unrestricted in 
caloric content, composition, and timing.
Instructions on whether to take MK-2060 with or without food and/or drink may be modified 
during the study based on newly available data.
5.3.2
Caffeine, Alcohol, and Tobacco Restrictions
5.3.2.1
Caffeine Restrictions
For Parts 1 and 3 participants will refrain from consumption of caffeinated beverages or 
xanthine-containing products from 12 hours before the pre-study and post-study visits and 
from 12 hours before and after study intervention administration in each treatment period. 
For Part 2 participants will refrain from consumption of caffeinated beverages or xanthine-
containing products from 12 hours before the pre-study and post-study visits and from 12 
hours before and after the first dose of study intervention administration. At all other times, 
caffeinated beverages or xanthine-containing products will be limited to no more than 6 units 
per day (1 unit = 120 mg of caffeine).
5.3.2.2
Alcohol Restrictions
Participants will refrain from consumption of alcohol 24 hours before the pre-study and 
poststudy visits and from 24 hours before and after study intervention administration in each 
treatment period. 
Participants will refrain from consumption of alcohol 12 hours prior to scheduled outpatient 
visits.
At all other times, alcohol consumption is limited to no more than approximately 3 alcoholic 
beverages or equivalent servings (1 serving is approximately equivalent to: beer [354 mL/12 
ounces], wine [118 mL/4 ounces], or distilled spirits [29.5 mL/1 ounce]) per day.
5.3.2.3
Tobacco Restrictions
Smoking (and/or the use of nicotine/nicotine-containing products) is permitted during the 
study. Participants should follow the CRU’s smoking restrictions during domiciling.
5.3.3
Activity Restrictions
Participants will avoid unaccustomed strenuous physical activity (i.e., weightlifting, running, 
bicycling, etc.) from the pre-study (screening) visit until administration of the initial dose of 
study intervention, throughout the study (including washout intervals between treatment 
periods) and until the poststudy visit.
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5.4
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently randomized in the study. A minimal set of screen failure information 
may be included, as outlined in the eCRF entry guidelines. Minimal information may include 
demography, screen failure details, eligibility criteria, and any AEs or SAEs meeting 
reporting requirements.
5.5
Participant Replacement Strategy
If a participant discontinues from study intervention or withdraws from the study within 21 
days after dosing a replacement participant may be enrolled if deemed appropriate by the 
investigator and Sponsor. The replacement participant will generally receive the same 
intervention or intervention sequence (as appropriate) as the participant being replaced. The 
replacement participant will be assigned a unique treatment/randomization number.
The replacement participant may begin dosing at the subsequent dose level for that panel, 
based on investigator and Sponsor review and discussion.
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6
STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to a study participant according to 
the study protocol.
Clinical supplies MK-2060 will be packaged to support enrollment and replacement 
participants as required. When a replacement participant is required, the Sponsor or designee 
needs to be contacted before dosing the replacement participant. Clinical supplies will be 
affixed with a clinical label in accordance with regulatory requirements.
6.1
Study Intervention(s) Administered
The study interventions to be used in this study are outlined in Table 1.
Country-specific requirements are noted in Appendix 7.
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Table 1
Study Interventions
Arm 
Name
Arm Type
Intervention 
Name
Intervention 
Type
Dose 
Formulation
Unit Dose 
Strength(s)
Dosage 
Level(s)
Route of 
Administration
Regimen/
Treatment 
Period/
Vaccination 
Regimen
Use
IMP or 
NIMP/
AxMP
Sourcing
MK-2060
Experimental MK-2060
Drug
Powder
15 mg/mL
30 mg
SC
Part 1: Day 1
Part 2: Days 
1, 2, 3, 4, 8, 
15, and 22
Part 3: Day 1
Test 
Product
IMP
Provided by 
Sponsor
Placebo
Placebo 
Comparator
Placebo
Drug
Solution
Saline
0 mg
SC
Part 1: Day 1
Part 2: Days 
1, 2, 3, 4, 8, 
15, and 22
Placebo
IMP
Locally
EEA=European Economic Area; IMP=investigational medicinal product; NIMP/AxMP=noninvestigational/auxiliary medicinal product; SC=subcutaneous.
The classification of IMP and NIMP/AxMP in this table is based on guidance issued by the European Commission and applies to countries in the EEA. Country differences 
with respect to the definition/classification of IMP and NIMP/AxMP may exist. In these circumstances, local legislation is followed.
In this protocol, placebo is diluent alone (normal saline); diluent is used for blinding purposes and does not contain active ingredients.
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All supplies indicated in Table 1 will be provided per the “Sourcing” column depending on 
local country operational requirements. If local sourcing, every attempt should be made to 
source these supplies from a single lot/batch number where possible (eg, not applicable in the 
case where multiple lots or batches may be required due to the length of the study, etc).
Refer to Section 8.1.8 for details regarding administration of the study intervention.
6.2
Preparation/Handling/Storage/Accountability
6.2.1
Dose Preparation
Specific calculations or evaluations required to be performed to administer the proper dose to 
each participant are outlined in a separate document provided by the Sponsor. The rationale 
for selection of doses to be used in this study is in Section 4.3.
6.2.2
Handling, Storage, and Accountability
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received, and any discrepancies are 
reported and resolved before use of the study intervention.
Only participants enrolled in the study may receive study intervention, and only authorized 
site staff may supply or administer study intervention. All study interventions must be stored 
in a secure, environmentally controlled, and monitored (manual or automated) area in 
accordance with the labeled storage conditions with access limited to the investigator and 
authorized site staff.
The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance (ie, 
receipt, reconciliation, and final disposition records).
For all study sites, the local country Sponsor personnel or designee will provide appropriate 
documentation that must be completed for drug accountability and return, or local discard 
and destruction if appropriate. Where local discard and destruction is appropriate, the 
investigator is responsible for ensuring that a local discard/destruction procedure is 
documented.
The study site is responsible for recording the lot number, manufacturer, and expiry date for 
any locally purchased product (if applicable) as per local guidelines unless otherwise 
instructed by the Sponsor.
The investigator shall take responsibility for and shall take all steps to maintain appropriate 
records and ensure appropriate supply, storage, handling, distribution, and usage of study 
interventions in accordance with the protocol and any applicable laws and regulations.
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6.3
Measures to Minimize Bias: Randomization and Blinding
6.3.1
Intervention Assignment
Participants will be assigned randomly according to a computer-generated allocation 
schedule. Sample allocation schedules are shown below in Table 2, Table 3, and Table 4.
Table 2
Sample Allocation Schedule for Part 1
Treatment Group
Participants
Dose
1
n=9
MK-2060 30 mg SC
2
n=3
Placebo
n=number of participants; SC=subcutaneous
Table 3
Sample Allocation Schedule for Part 2
Treatment Group
Participantsa
Dose
1
n=9
MK-2060 30 mg SC
2
n=3
Placebo
a. To ensure a minimum of 3 CDK4 and CKD5 participants receive MK-2060, assignment of randomization numbers for 
CKD4 participants will occur in ascending order (starting block). Assignment of randomization number for CKD5 
participants will occur in descending order (ending block).
n=number of participants; SC=subcutaneous
Table 4
Sample Allocation Schedule for Part 3
Treatment Group
Participants
Dose
1
n=9
MK-2060 30 mg SC
n=number of participants; SC=subcutaneous
6.3.2
Stratification
No stratification based on age, sex, or other characteristics will be used in this study.
6.3.3
Blinding
For this study a double-blinding technique will be used. MK-2060 and placebo will be 
prepared and/or dispensed in a blinded fashion by an unblinded pharmacist or qualified 
study-site personnel. The participant, the investigator, and Sponsor personnel or delegate(s) 
who are involved in the study intervention administration or clinical evaluation of the 
participants are unaware of the intervention assignments.
See Section 8.1.10 for a description of the method of unblinding a participant during the 
study should such action be warranted.
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6.4
Study Intervention Compliance
Interruptions from the protocol-specified treatment plan require consultation between the 
investigator and the Sponsor and written documentation of the collaborative decision on 
participant management.
When the individual dose for a participant is prepared from a bulk supply, the preparation of 
the dose will be confirmed by a second member of the study-site staff.
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents and recorded in the CRF. 
The dose of study intervention and study participant identification will be confirmed at the 
time of dosing by a member of the study-site staff other than the person administering the 
study intervention.
6.5
Concomitant Therapy
Concomitant use of the following medications will be allowed during the conduct of the 
study as long as the participant has been on a stable dose and treatment regimen for 
approximately 2 weeks prior and is able to withhold the use within four hours prior to 
administration of the first dose of study drug in each panel of the study. The name (generic 
and brand), dose and regimen for all concomitant medications should be recorded on the 
appropriate CRF.
All medications must be reviewed and approved by the Sponsor clinical monitor prior to 
enrollment of an individual patient.  This list is not exhaustive, but serves as a guideline to 
facilitate the approval process between the investigator and the Sponsor clinical monitor
ALLOWED MEDICATIONS
Lipid Lowering Agents: Statins
Lipid Lowering Agents: Fibrates
Lipid Lowering Agents: Other
Ezetimibe
Anti-Hypertensive Medications:
Monotherapy and combination therapy with an ACE inhibitor, an angiotensin II receptor 
antagonist, beta blockers, calcium channel blockers, or a diuretic is allowed in the study.
Specific therapeutic categories include:
1. ACE inhibitors
2. Angiotensin II Receptor Antagonists
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3. Diuretics
4. Beta-blockers
5. Calcium channel-blockers
Diabetes Medications
Specific therapeutic categories include:
6. Insulin
7. Metformin
8. Sulfonylureas 
9. Meglitinides
10. Thiazolidinediones
11. DPP-4 Inhibitors
12. GLP-1 Analogs
Aspirin
Low-dose aspirin is permitted in the study.
Clopidogrel
Clopidogrel is permitted based on results from P008.
Iron
Phosphate Binders
Vitamin D
Erythropoietin
Note: All efforts should be made to inject other injectable medications (ie, insulin, GLP-1 
analogs, erythropoietin) for which the participant has been on a stable regimen in a location 
other than where the study medication/placebo is injected. It is preferred that the MK-2060 
injection site area is not used for other injections for the duration of the study, if possible. 
PROHIBITED MEDICATIONS
Listed below are specific restrictions for concomitant therapy during the course of the study, 
from signing consent to the poststudy visit:
Oral Anticoagulants
Warfarin
Apixaban
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Dabigatran
Rivaroxaban
Edoxaban
Betrixaban
Antiplatelet Medications
Prasugrel
Ticagrelor
Ticlopidine
NSAIDs (eg, ibuprofen); however, the non-NSAID paracetamol/acetaminophen may be used 
for minor ailments without prior consultation with the Sponsor.
6.5.1
Rescue Medications and Supportive Care
No rescue or supportive medications are specified for use in this study.
CRUs will be staffed with medically trained personnel with appropriate access to full service 
acute-care hospitals to facilitate rapid institution of medical intervention.
6.6
Dose Modification (Escalation/Titration/Other)
The dose and administration of the study intervention to any participant may be modified 
based on newly available safety, tolerability, pharmacokinetic and/or pharmacodynamic data 
observed in this and/or other MK-2060 studies. If necessary, a participant must be 
discontinued for the reasons described in Section 7.
6.6.1
Stopping Rules
The following stopping rules will be used during the conduct of this study.
If any of the below stopping rules are met, the study will be paused, and no further dosing 
will occur until the Sponsor has reviewed the totality of data available. To continue the study 
(on joint agreement with the Sponsor and investigator), a substantial amendment will be 
submitted for approval.
1. An individual participant reports an SAE considered related to the study intervention by 
the investigator.
2. Two (2) or more participants within a Panel (at the same dose level) report Severe 
Nonserious AEs considered related to the study intervention by the investigator.
3. An increase in local lab aPTT >4.0-fold versus screening baseline as confirmed after
repeat measurement in 2 or more participants in a panel. Local lab aPTT measured at 
Screening Visit should be used as baseline value.
4. An increase in local lab PT >1.5-fold versus screening baseline as confirmed after repeat 
measurement in 2 or more participants in a panel. Local lab PT measured at Screening 
Visit should be used as baseline value.
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6.7
Intervention After the End of the Study
There is no study-specified intervention after the end of the study.
6.8
Clinical Supplies Disclosure
The emergency unblinding call center will use the intervention randomization schedule for 
the study to unblind participants and to unmask study intervention identity for this study. The 
emergency unblinding call center should only be used in cases of emergency (see Section 
8.1.10). The Sponsor will not provide random code/disclosure envelopes or lists with the 
clinical supplies.
6.9
Standard Policies
MK-2060 will be provided by the Sponsor in sufficient quantity to complete the study.
6.9.1
Study Site Retention Samples
Not applicable.
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7
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
WITHDRAWAL
7.1
Discontinuation of Study Intervention
Discontinuation of study intervention does not represent withdrawal from the study.
As certain data on clinical events beyond study intervention discontinuation may be 
important to the study, they must be collected through the participant’s last scheduled follow-
up, even if the participant has discontinued study intervention. Therefore, all participants 
who discontinue study intervention prior to completion of the protocol-specified treatment 
period regimen will still continue to participate in the study as specified in Section 7.1 and 
Section 8.1.9, or if available, a PCL. Safety procedures include full physical examination, 
systemic infusion reaction assessment, semi-recumbent VS, orthostatic VS, safety lab 
measurements, AE reviews, and assessment of time to hemostasis if on-site dialysis. The 
poststudy timing and assessments should be performed as outlined in Section 1.3.2.
Participants may discontinue study intervention at any time for any reason or be discontinued 
from the study intervention at the discretion of the investigator should any untoward effect 
occur. In addition, a participant may be discontinued from study intervention by the 
investigator or the Sponsor if study intervention is inappropriate, the study plan is violated, or 
for administrative and/or other safety reasons. Specific details regarding procedures to be 
performed at study intervention discontinuation are provided in Section 8.1.9.
A participant must be discontinued from study intervention but continue to be monitored in 
the study for any of the following reasons:
•
The participant or participant’s legally acceptable representative requests to discontinue 
study intervention.
•
The participant’s treatment assignment has been unblinded by the investigator, MSD, or 
through the emergency unblinding call center.
•
The participant has a medical condition or personal circumstance which, in the opinion of 
the investigator and/or Sponsor, placed the participant at unnecessary risk from continued 
administration of study intervention.
7.2
Participant Withdrawal From the Study
A participant must be withdrawn from the study if the participant or participant’s legally 
acceptable representative withdraws consent from the study.
If a participant withdraws from the study, they will no longer receive study intervention or be 
followed at scheduled protocol visits.
Specific details regarding procedures to be performed at the time of withdrawal from the 
study, as well as specific details regarding withdrawal from FBR, are outlined in 
Section 8.1.9. The procedures to be performed should a participant repeatedly fail to return 
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for scheduled visits and/or if the study site is unable to contact the participant are outlined in
Section 7.3.
7.3
Lost to Follow-up
If a participant fails to return to the clinic for a required study visit and/or if the site is unable 
to contact the participant, the following procedures are to be performed:
•
The site must attempt to contact the participant and reschedule the missed visit. If the 
participant is contacted, the participant should be counseled on the importance of 
maintaining the protocol-specified visit schedule.
•
The investigator or designee must make every effort to regain contact with the participant 
at each missed visit (eg, telephone calls and/or a certified letter to the participant’s last 
known mailing address or locally equivalent methods). These contact attempts should be 
documented in the participant’s medical record.
•
Note: A participant is not considered lost to follow-up until the last scheduled visit for the 
individual participant. The missing data for the participant will be managed via the 
prespecified statistical data handling and analysis guidelines.
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8
STUDY ASSESSMENTS AND PROCEDURES
•
Study procedures and their timing are summarized in the SoA.
•
Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct.
•
The investigator is responsible for ensuring that procedures are conducted by 
appropriately qualified (by education, training, and experience) staff. Delegation of 
study-site personnel responsibilities will be documented in the Investigator Trial File 
Binder (or equivalent).
•
All study-related medical decisions must be made by an investigator who is a qualified 
physician.
•
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
•
Procedures conducted as part of the participant’s routine clinical management (eg, blood 
count) and obtained before signing of ICF may be used for screening or baseline purposes 
provided the procedures meet the protocol-specified criteria and were performed within 
the time frame defined in the SoA.
•
Additional evaluations/testing may be deemed necessary by the investigator and or the 
Sponsor for reasons related to participant safety. In some cases, such evaluation/testing 
may be potentially sensitive in nature (eg, HIV, hepatitis C), and thus local regulations 
may require that additional informed consent be obtained from the participant. In these 
cases, such evaluations/testing will be performed in accordance with those regulations.
•
The maximum amount of blood collected from each participant over the duration of Part 
1 will not exceed ~294.8 mL, over Part 2 will not exceed ~428.3 mL, and over Part 3 will 
not exceed ~320.2 mL (Appendix 8 and operations/laboratory manual).
•
Repeat or unscheduled samples may be taken for safety reasons or for technical issues 
with the samples.
8.1
Administrative and General Procedures
8.1.1
Informed Consent
The investigator or medically qualified designee (consistent with local requirements) must 
obtain documented informed consent from each potential participant (or their legally 
acceptable representative) prior to participating in this clinical study or FBR. If there are 
changes to the participant’s status during the study (eg, health or age of majority 
requirements), the investigator or medically qualified designee must ensure the appropriate 
documented informed consent is in place.
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8.1.1.1
General Informed Consent
Informed consent given by the participant or their legally acceptable representative must be 
documented on a consent form. The form must include the study protocol number, study 
protocol title, dated signature, and agreement of the participant (or his/her legally acceptable 
representative) and of the person conducting the consent discussion.
A copy of the signed and dated informed consent form should be given to the participant (or 
their legally acceptable representative) before participation in the study.
The initial ICF, any subsequent revised ICF, and any written information provided to the 
participant must receive the IRB/IEC’s approval/favorable opinion in advance of use. The 
participant or his/her legally acceptable representative should be informed in a timely manner 
if new information becomes available that may be relevant to the participant’s willingness to 
continue participation in the study. The communication of this information will be provided 
and documented via a revised consent form or addendum to the original consent form that 
captures the participant’s or the participant’s legally acceptable representative’s dated 
signature.
If the investigator recommends continuation of study intervention beyond disease 
progression, the participant or their legally acceptable representative will be asked to provide 
documented informed consent.
Specifics about the study and the study population are to be included in the study informed 
consent form.
Informed consent will adhere to IRB/IEC requirements, applicable laws and regulations, and 
Sponsor requirements.
8.1.1.2
Consent and Collection of Specimens for Future Biomedical Research
The investigator or medically qualified designee will explain the FBR consent to the 
participant, or the participant’s legally acceptable representative, answer all of his/her 
questions, and obtain documented informed consent before performing any procedure related 
to FBR. A copy of the informed consent will be given to the participant before performing 
any procedure related to FBR.
8.1.2
Inclusion/Exclusion Criteria
All inclusion and exclusion criteria will be reviewed by the investigator, who is a qualified 
physician, to ensure that the participant qualifies for the study.
8.1.3
Participant Identification Card
All participants will be given a participant identification card identifying them as participants 
in a research study. The card will contain study-site contact information (including direct 
telephone numbers) to be used in the event of an emergency. The investigator or qualified 
designee will provide the participant with a participant identification card immediately after 
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the participant provides documented informed consent. At the time of intervention
randomization, site personnel will add the treatment/randomization number to the participant 
identification card.
The participant identification card also contains contact information for the emergency 
unblinding call center so that a health care provider can obtain information about study 
intervention in emergency situations where the investigator is not available.
8.1.4
Medical History
A medical history will be obtained by the investigator or qualified designee.
8.1.5
Prior and Concomitant Medications Review
8.1.5.1
Prior Medications
The investigator or qualified designee will review before medication use, including any 
protocol-specified washout requirement, and record prior medication taken by the participant 
within 28 days before starting the study.
8.1.5.2
Concomitant Medications
The investigator or qualified designee will record medication, if any, taken by the participant 
during the study. Refer to Section 6.5 for guidelines on concomitant medication use.
8.1.6
Assignment of Screening Number
All consented participants will be given a unique screening number that will be used to 
identify the participant for all procedures that occur before randomization. Each participant 
will be assigned only 1 screening number. Screening numbers must not be reused for 
different participants.
8.1.7
Assignment of Treatment/Randomization Number
For Parts 1 and 2, all eligible participants will be randomly allocated and will receive a 
treatment/randomization number. For Part 3, all eligible participants will be allocated, by 
nonrandom assignment, and will receive a treatment/allocation number. The
treatment/randomization/allocation number identifies the participant for all procedures 
occurring after treatment randomization/allocation. Once a 
treatment/randomization/allocation number is assigned to a participant, it can never be 
reassigned to another participant.
A single participant cannot be assigned more than 1 treatment/randomization/allocation
number.
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8.1.8
Study Intervention Administration
Administration of study medication will be witnessed by the investigator and/or study staff 
according to the specifications within the Study Pharmacy Manual.
8.1.8.1
Timing of Dose Administration
MK-2060/placebo will be prepared and dosed per the instructions outlined in the Study 
Pharmacy Manual. All doses of MK-2060 or placebo will be given in the morning and after 
at least an 8-hour fast. Total dosing time should not exceed approximately 1 minute. The fast 
will be maintained until 2-hours postdose, at which time a standard light breakfast will be 
served. Participants will also remain semi-recumbent for 4 hours post-dose except to stand 
for the measurement of orthostatic VS (if needed) or other study procedures (for example for 
breakfast).
8.1.9
Discontinuation and Withdrawal
The investigator or study coordinator must notify the Sponsor when a participant has been 
discontinued/withdrawn from the study. If a participant discontinues for any reason at any 
time during the course of the study, the participant may be asked to return to the clinic (or be 
contacted) for a poststudy visit as per the number of days described in Section 1.3 (90 days
for Part 1, 130 days for Part 2, and 120 days for Part 3) to have the applicable procedures 
conducted. However, the investigator may decide to perform the poststudy procedures at the 
time of discontinuation or as soon as possible after discontinuation. If the poststudy visit 
occurs prior to the safety follow-up time frame as specified in Section 8.4.1, the investigator 
should perform a follow-up telephone call at the end of the follow-up period (Section 8.4.1) 
to confirm if any AEs have occurred since the poststudy clinic visit. Any AEs that are present 
at the time of discontinuation/withdrawal should be followed in accordance with the safety 
requirements outlined in Section 8.4.
8.1.9.1
Withdrawal From Future Biomedical Research
Participants may withdraw their consent for FBR. Participants may withdraw consent at any 
time by contacting the study investigator. If medical records for the study are still available, 
the investigator will contact the Sponsor using the designated mailbox 
(clinical.specimen.management@MSD.com). Subsequently, the participant’s consent for 
FBR will be withdrawn. A letter will be sent from the Sponsor to the investigator confirming 
the withdrawal. It is the responsibility of the investigator to inform the participant of 
completion of withdrawal. Any analyses in progress at the time of request for withdrawal or 
already performed before the request being received by the Sponsor will continue to be used 
as part of the overall research study data and results. No new analyses would be generated 
after the request is received.
If the medical records for the study are no longer available (eg, if the investigator is no longer 
required by regulatory authorities to retain the study records) or the specimens have been 
completely anonymized, there will no longer be a link between the participant’s personal 
information and their specimens. In this situation, the request for specimen withdrawal 
cannot be processed.
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8.1.10
Participant Blinding/Unblinding
STUDY INTERVENTION IDENTIFICATION INFORMATION IS TO BE UNMASKED 
ONLY IF NECESSARY FOR THE WELFARE OF THE PARTICIPANT. EVERY 
EFFORT SHOULD BE MADE NOT TO UNBLIND.
For emergency situations where the investigator or medically qualified designee (consistent 
with local requirements) needs to identify the intervention used by a participant and/or the 
dosage administered, he/she will contact the emergency unblinding call center by telephone 
and make a request for emergency unblinding. As requested by the investigator or medically 
qualified designee, the emergency unblinding call center will provide the information to 
him/her promptly and report unblinding to the Sponsor. Before contacting the emergency 
unblinding call center to request unblinding of a participant’s intervention assignment, the 
investigator who is qualified physician should make reasonable attempts to enter the intensity 
of the AEs observed, the relation to study intervention, the reason thereof, etc, in the medical 
record. If it is not possible to record this assessment in the medical record before the 
unblinding, the unblinding should not be delayed.
If unblinding has occurred, the circumstances around the unblinding (eg, date, reason, and 
person performing the unblinding) must be documented promptly, and the Sponsor Clinical 
Director notified as soon as possible.
Once an emergency unblinding has taken place, the investigator, site personnel, and Sponsor 
personnel may be unblinded so that the appropriate follow-up medical care can be provided 
to the participant.
Participants whose treatment assignment has been unblinded by the investigator or medically 
qualified designee and/or nonstudy treating physician must be discontinued from study 
intervention, but should continue to be monitored in the study.
8.1.11
Domiciling
For Parts 1 and 3 participants will report to the CRU the evening before the scheduled day of 
study intervention administration for each treatment period. Participants will remain in the 
unit until at least 48-hours postdose. For Part 2 participants will report to the CRU the 
evening before the scheduled day of study intervention administration on Day 1 and will 
remain in the unit until the completion of off all postdose procedures on Day 4 (at least 4 
hours). For the remaining dosing days in Part 2, at the discretion of the investigator the 
participants will return to the CRU either the evening before the scheduled day of study 
intervention administration or the morning of the scheduled day of study intervention 
administration (Days 8, 15 and 22) and will remain in the unit overnight until the completion 
of all postdose procedures the following day (at least 4 hours). At the discretion of the 
investigator, participants may be requested to remain in the CRU longer.
8.1.12
Calibration of Equipment
The investigator or qualified designee has the responsibility to ensure that any device or 
instrument used for a clinical evaluation/test during a clinical study that provides information 
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about inclusion/exclusion criteria and/or safety or efficacy parameters shall be suitably 
calibrated and/or maintained to ensure that the data obtained are reliable and/or reproducible. 
Documentation of equipment calibration must be retained as source documentation at the 
study site.
8.2
Efficacy/Immunogenicity Assessments
There are no direct efficacy/immunogenicity assessments in this study.
8.3
Safety Assessments
Details regarding specific safety procedures/assessments to be performed in this study are 
provided. The total amount of blood to be drawn over the course of the study (from pre-study 
to poststudy visits), including approximate blood volumes drawn by visit and by sample type 
per participant, can be found in Appendix 8.
Planned time points for all safety assessments are provided in the SoA.
8.3.1
Physical Examinations
A complete physical examination will be conducted by an investigator or medically qualified 
designee (consistent with local requirements) per institutional standard as per the SoA. A 
symptom driven physical exam will be conducted based upon any emergent symptoms at the 
discretion of the investigator. Height and weight will also be measured and recorded.
Investigators should pay special attention to clinical signs related to previous serious 
illnesses.
Targeted physical examination will involve a skin exam to assess for any unusual bruising or 
bleeding under the skin.
8.3.1.1
Body Weight and Height
Body weight and height will be obtained with the participant’s shoes off and jacket or coat 
removed.
8.3.1.2
Body Mass Index (BMI)
BMI equals a person's weight in kilograms divided by height in meters squared 
(BMI=kg/m2). BMI will be rounded to the nearest whole number according to the standard 
convention of 0.1 to 0.4 round down and 0.5 to 0.9 round up.
8.3.2
Vital Signs
•
Body temperature, HR, RR, and BP will be assessed.
•
BP and pulse measurements will be assessed semi-recumbent after at least 10 minutes 
rest with a completely automated device. Manual techniques will be used only if an 
automated device is not available.
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8.3.2.1
Resting Vital Signs
Vital Sign Measurements (Heart Rate and Blood Pressure)
Participants should be resting in a quiet setting without distractions in a semi-recumbent 
position for at least 10 minutes before having VS measurements obtained. Semi-recumbent 
VS will include HR, systolic and diastolic BP, RR, and body temperature at timepoints 
indicated in the SoA. The correct size of the BP cuff and the correct positioning on the 
participant’s arm is essential to increase the accuracy of BP measurements.
For Parts 1, 2, and 3, the Day 1 predose (baseline) HR and BP will be in triplicate 
measurements, obtained at least 1 to 2 minutes apart within 3 hours of dosing of study 
intervention. The median of these measurements will be used as the baseline to calculate 
change from baseline for safety evaluations (and for rechecks, if needed). Post-dose VS 
measurements will be single measurements.
Participants will continue to rest semi-recumbent from dosing until 4 hours post-dose except 
to stand for the measurement of orthostatic VS (if needed) or other study-related procedure.
Body Temperature
Body temperature will be a single measurement at all timepoints. The same method must be 
used for all measurements for each individual participant and should be the same for all 
participants.
Respiratory Rate
Respiratory rate (breaths per minute) will be measured and recorded as single measurements.
8.3.2.2
Orthostatic Vital Signs
Orthostatic VS (HR and systolic and diastolic BP) will also be obtained. Participants should 
be semi-recumbent for at least 10 minutes and then stand upright for approximately 
2 minutes before measurement of orthostatic VS.
8.3.3
Electrocardiograms
•
Triplicate and single 12-lead ECG will be obtained and reviewed by an investigator or 
medically qualified designee (consistent with local requirements) as outlined in the SoA 
using an ECG machine that automatically calculates the HR and measures PR, QRS, QT, 
and QTc intervals. 
•
At each time point when triplicate ECG are required, 3 individual ECG tracings should 
be obtained at least 1 to 2 minutes apart, but no more than 2 minutes apart. The full set of 
triplicates should be completed in no more than 6 minutes.
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Special care must be taken for proper lead placement by qualified personnel. Skin should be 
clean and dry before lead placement. Participants may need to be shaved to ensure proper 
lead placement. Female participants may need to remove interfering garments.
Lead placements should be rechecked in cases where unexpected ECG findings are noted.
Participants should be resting in the semi-recumbent for at least 10 minutes before each ECG 
measurement.
The QTc correction formula to be used at the site (for safety and inclusion/exclusion criteria 
assessments) is Fridericia.
If repeat ECGs are required, the clinical site will decide whether to leave the electrodes in 
place or mark the position of the electrodes for subsequent ECGs. To mark the position of the 
electrodes, 12-lead electrode sites will be marked on the skin of each participant with an 
ECG skin-marker pen to ensure reproducible electrode placement.
For Parts 1, 2, and 3, the Day 1 Pre-dose ECGs will be obtained in triplicate at least 1 to 2 
minutes apart (and should be completed in no more than 6 minutes) within 3 hours prior to 
dosing MK-2060. The median of these measurements will be used as the baseline to calculate 
change from baseline for safety evaluations (and for rechecks, if needed). Unless otherwise 
designated in the flow chart, post-dose ECG measurements will be single measurements.
If a participant demonstrates an increase in QTc interval ≥60 msec compared with median 
pre-dose baseline measurement, the ECG will be repeated twice within 5 minutes. The 
median value of the QTc interval from the 3 ECGs will represent the value at that time point. 
If the median QTc interval increase from baseline for any post-dose time point is ≥60 msec, 
the participant will continue to be monitored by repeat 12-lead ECGs every 15 minutes for at 
least 1 hour or until the QTc is within 60 msec of baseline. If prolongation of the QTc 
interval ≥60 msec persists, a consultation with a study cardiologist may be appropriate and 
the Sponsor should be notified.
If the median QTc interval is ≥500 msec, the Sponsor should be notified, and the ECGs 
should be reviewed by a cardiologist. The participant should be telemetry monitored (until 
the QTc is <500 msec) or should be considered for transfer to a location where closer 
monitoring and definitive care (eg, a CCU or ICU) is available.
If the participant has unstable hemodynamics, or has any clinically significant dysrhythmias 
noted on telemetry, the participant should be immediately transferred to an acute care setting 
for definitive therapy.
If prolongation of the QTc is noted, concomitant medications that prolong QTc should be 
held until the QTc is within 60 msec of baseline and the QTc is <500 msec.
A study cardiologist should be arranged by the Principal Investigator to be available as 
needed to review ECG tracings with abnormalities.
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8.3.4
24-Hour Urine Protein, 24-Hour Urine Creatinine and Spot Urine Collection 
for Urine Protein: Urine Creatinine Ratio (uPCR)
A 24-hour urine protein will be collected. The collection will begin following admission to 
the CRU on the evening before study intervention dosing on Day 1 and continue through to 
the evening of Day 1.
Spot urine for uPCR will be collected on study days as defined in the study flowchart (SoA).
8.3.5
Clinical Safety Laboratory Assessments
Refer to Appendix 2 for the list of clinical laboratory tests to be performed and to the SoA for 
the timing and frequency.
•
The investigator or medically qualified designee (consistent with local requirements) 
must review the laboratory report, document this review, and record any clinically 
relevant changes occurring during the study in the AE section of the CRF. The laboratory 
reports must be filed with the source documents. Clinically significant abnormal 
laboratory findings are those which are not associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the participant’s condition.
•
All protocol-required laboratory assessments, as defined in Appendix 2, must be 
conducted in accordance with the laboratory manual and the SoA.
•
If laboratory values from nonprotocol-specified laboratory assessments performed at the 
institution’s local laboratory require a change in study participant management or are 
considered clinically significant by the investigator (eg, SAE or AE or dose 
modification), then the results must be recorded in the appropriate CRF (eg, SLAB).
•
For any laboratory tests with values considered clinically significantly abnormal during 
participation In the study or within 90 days after the last dose of study intervention, every 
attempt should be made to perform repeat assessments until the values return to normal or 
baseline or if a new baseline is established as determined by the investigator.
8.3.6
Hemoccult Test
Hemoccult test will be provided to participants at Screening 1 Visit and participants will 
return the sample at Screening 2 Visit. Following dosing, hemoccult tests will be provided on 
visit days designated in the SoA and can be returned at the next scheduled visit. Further 
instructions and information regarding the hemoccult test will be provided in the Study 
Operations Manual by the Sponsor
8.3.7
Photograph of Rash
Photographs of the rash are highly recommended to be taken immediately, along with any 
additional information that may assist the investigator to evaluate the skin reaction, skin 
eruption, or rash occurrence in determining etiology and study intervention relationship.
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8.3.8
Management of Injection Reaction During and Post-Dose
As outlined in IB, the risk of injection reactions to MK-2060 is considered low since the 
molecule contains primarily human sequences. However, injection reactions may be 
observed. Since the purpose of the study is to characterize the safety profile of MK-2060, no 
prophylactic premedications to reduce the risk of injection reactions will be given prior to 
MK-2060 administration. 
In rare instances, systemic injection reactions are severe and may have a fatal outcome. It is 
likely that most injection reactions will occur within the first 30 to 60 minutes of 
administration, though they may be observed up to 24 to 30 hours postdose. An anaphylactic 
reaction is a severe type of injection reaction that is characterized by cutaneous and mucosal 
symptoms, such as generalized hives, pruritus or flushing, swollen lips-tongue-uvula and 
angioedema, accompanied by respiratory compromise (bronchospasm, stridor or hoarseness) 
and/or changes in blood pressure (hypotension). Severe injection reactions, including 
cytokine release syndrome and hypersensitivity reactions must be promptly treated with 
interruption of the injection, medical management, appropriate monitoring, and life-saving 
measures. Appropriate resuscitation equipment and a physician should be readily available 
during the period of drug administration. 
All participants should be evaluated for injection-type reactions. Participants should be 
carefully observed until complete resolution of all signs and symptoms, if a reaction occurs. 
Report any adverse experiences according to the guidelines in Section 8.4.
8.3.8.1
Systemic Injection Reaction Assessment
Participants will be monitored during the administration of MK-2060/placebo and for at least 
4 hours and up to 24 to 48 hours postdose at the CRU after the initiation of administration. 
During this time, signs and symptoms of a systemic injection reaction, including but not 
limited to fever, VS changes (tachycardia/hypotension), pruritis, urticarial (hives), lip 
swelling, angioedema, bronchospasm, stridor, hoarseness, and shortness of breath will be 
monitored. Injection reactions must be assessed and managed promptly. Such assessment and 
management are discussed in Section 8.3.7.
8.3.8.2
Local Injection Reaction Assessment
A local injection site examination will be obtained as outlined in the Section 1.3 and will 
include an assessment of any pain, tenderness, erythema/redness and induration/swelling. 
These events will be evaluated based upon the system outlined in the guidance for the 
industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in 
Preventive Vaccine Clinical Trials in Table 5. Injection reactions must be assessed and 
managed promptly per site procedure. 
Participants who call the CRU to report an infusion/injection site reaction within 7 days post-
dose may be asked to return to the CRU as soon as possible for an additional local injection 
site reaction assessment.
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Table 5
Local Injection Reaction Assessment
Local Site 
Reaction
Mild
Moderate
Severe
Potentially Life 
Threatening
Pain
Does not interfere 
with activity
Repeated use of 
non-narcotic pain 
reliever >24 hr or 
interferes with 
activity
Any use of 
narcotic pain 
reliever or prevents 
daily activity
Emergency room 
(ER) visit or 
hospitalization
Tenderness
Mild discomfort to 
touch
Discomfort with 
movement
Significant 
discomfort at rest
ER visit or 
hospitalization
Erythema/Redness
2.5 – 5 cm
5.1 – 10 cm
>10 cm
Necrosis or 
exfoliative 
dermatitis
Induration/Swelling
2.5 – 5 cm and 
does not interfere 
with activity
5.1 – 10 cm or 
interferes with 
activity
>10 cm or prevents 
daily activity
Necrosis
Adapted from the guidance for the industry Toxicity Grading Scale for Healthy Adult and Adolescent 
Volunteers Enrolled in Preventive Vaccine Clinical Trials.
8.4
Adverse Events, Serious Adverse Events, and Other Reportable Safety Events
The definitions of an AE or SAE, as well as the method of recording, evaluating, and 
assessing causality of AE and SAE and the procedures for completing and transmitting AE, 
SAE, and other reportable safety event reports can be found in Appendix 3.
Adverse events, SAEs, and other reportable safety events will be reported by the participant 
(or, when appropriate, by a caregiver, surrogate, or the participant’s legally authorized 
representative).
The investigator and any designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE as well as other reportable safety events. 
Investigators need to document if an SAE was associated with a medication error, misuse, or 
abuse.
Investigators remain responsible for following up AEs, SAEs, and other reportable safety 
events for outcome according to Section 8.4.3. The investigator, who is a qualified physician, 
will assess events that meet the definition of an AE or SAE as well as other reportable safety 
events with respect to seriousness, intensity/toxicity, and causality.
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8.4.1
Time Period and Frequency for Collecting AE, SAE, and Other Reportable 
Safety Event Information
AEs, SAEs, and other reportable safety events that occur after the participant provides 
documented informed consent, but before intervention randomization, must be reported by 
the investigator under any of the following circumstances:
•
if the participant is receiving placebo run-in or other run-in treatment,
•
if the event causes the participant to be excluded from the study,
•
if it is the result of a protocol-specified intervention, including, but not limited to washout 
or discontinuation of usual therapy, diet, placebo, or a procedure.
From the time of intervention randomization through ~96 days after cessation of 
intervention, all AEs, SAEs and other reportable safety events must be reported by the 
investigator
Additionally, any SAE brought to the attention of an investigator any time outside the period 
specified in the previous paragraph also must be reported immediately to the Sponsor if the 
event is considered related to study intervention.
Investigators are not obligated to actively seek AEs or SAEs or other reportable safety events 
in former study participants. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has been discharged from the study, and the investigator 
considers the event to be reasonably related to the study intervention or study participation, 
the investigator must promptly notify the Sponsor.
All initial and follow-up AEs, SAEs, and other reportable safety events will be recorded and 
reported to the Sponsor or designee within the time frames as indicated in Table 6.
Exception: A positive pregnancy test at the time of initial screening is not a reportable event 
unless the participant has received study intervention.
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Table 6
Reporting Time Periods and Time Frames for Adverse Events and Other 
Reportable Safety Events
Type of Event
Reporting Period:
Consent to 
Randomization/
Allocation
Reporting Period:
Randomization/
Allocation 
through Protocol-
specified Follow-
up Period
Reporting 
Period:
After the 
Protocol-
specified Follow-
up Period
Time Frame to 
Report Event 
and Follow-up 
Information to 
Sponsor
NSAE
Report if:
– due to protocol-
specified 
intervention
– causes exclusion
– participant is 
receiving placebo 
run-in or other run-
in treatment
Report all
Not required
Per data entry 
guidelines
SAE
Report if:
– due to protocol-
specified 
intervention
– causes exclusion
– participant is 
receiving placebo 
run-in or other run-
in treatment
Report all
Report if:
– drug/vaccine 
related.
(Follow 
ongoing to 
outcome)
Within 
24 hours of 
learning of 
event
Pregnancy/Lactation 
Exposure
Report if:
– participant has been 
exposed to any 
protocol-specified 
intervention (eg, 
procedure, washout,
or run-in treatment 
including placebo 
run-in)
Exception: A positive 
pregnancy test at the 
time of initial 
screening is not a 
reportable event.
Report all
Previously 
reported – Follow 
to completion/
termination; 
report outcome
Within 
24 hours of 
learning of 
event
ECI (require 
regulatory reporting)
Report if:
– due to intervention
– causes exclusion
Report
– potential DILI
– require regulatory 
reporting
Not required
Within 
24 hours of 
learning of 
event
ECI (do not require 
regulatory reporting)
Report if:
– due to intervention
– causes exclusion
Report
– non-DILI ECIs 
and those not 
requiring 
regulatory 
reporting
Not required
Within 
5 calendar days 
of learning of 
event
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Type of Event
Reporting Period:
Consent to 
Randomization/
Allocation
Reporting Period:
Randomization/
Allocation 
through Protocol-
specified Follow-
up Period
Reporting 
Period:
After the 
Protocol-
specified Follow-
up Period
Time Frame to 
Report Event 
and Follow-up 
Information to 
Sponsor
Cancer
Report if:
– due to intervention
– causes exclusion
Report all
Not required
Within 
5 calendar days 
of learning of 
event (unless 
serious)
Overdose
Report if:
– receiving placebo 
run-in or other run-
in medication 
Report all
Not required
Within 
24 hours of 
learning of 
event
DILI=drug-induced liver injury; ECI=event of clinical interest; NSAE=nonserious adverse event; SAE=serious 
adverse event.
8.4.2
Method of Detecting AEs, SAEs, and Other Reportable Safety Events
Care will be taken not to introduce bias when detecting AEs and/or SAEs and other 
reportable safety events. Open-ended and nonleading verbal questioning of the participant is 
the preferred method to inquire about AE occurrence.
8.4.3
Follow-up of AE, SAE, and Other Reportable Safety Event Information
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. All AEs, SAEs, and other reportable safety events, 
including pregnancy and exposure during breastfeeding, ECIs, cancer, and overdose will be 
followed until resolution, stabilization, until the event is otherwise explained, or the 
participant is lost to follow-up (as defined in Section 7.3). In addition, the investigator will 
make every attempt to follow all nonserious AEs that occur in randomized participants for 
outcome. Further information on follow-up procedures is given in Appendix 3.
8.4.4
Regulatory Reporting Requirements for SAE
Prompt notification (within 24 hours) by the investigator to the Sponsor of SAE is essential 
so that legal obligations and ethical responsibilities toward the safety of participants and the 
safety of a study intervention under clinical investigation are met.
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
Sponsor will comply with country-specific regulatory requirements and global laws and 
regulations relating to safety reporting to regulatory authorities, IRB/IECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and Sponsor policy and forwarded to investigators as necessary.
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An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAEs) from the Sponsor will file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements.
8.4.5
Pregnancy and Exposure During Breastfeeding
Although pregnancy and infant exposure during breastfeeding are not considered AEs, any 
pregnancy or infant exposure during breastfeeding in a participant (spontaneously reported to 
the investigator or their designee) that occurs during the study are reportable to the Sponsor.
All reported pregnancies must be followed to the completion/termination of the pregnancy.
Any pregnancy complication will be reported as an AE or SAE.
The medical reason (example: maternal health or fetal disease) for an elective termination of 
a pregnancy will be reported as an AE or SAE. Prenatal testing showing fetus will be born 
with severe abnormalities/congenital anomalies that leads to an elective termination of a 
pregnancy will be reported as an SAE for the fetus.
Pregnancy outcomes of ectopic pregnancy, spontaneous abortion, missed abortion, benign 
hydatidiform mole, blighted ovum, fetal death, intrauterine death, miscarriage, and stillbirth 
must be reported as serious events (Important Medical Events). If the pregnancy continues to 
term, the outcome (health of infant) must also be reported.
8.4.6
Disease-related Events and/or Disease-related Outcomes Not Qualifying as 
AEs or SAEs
Not applicable.
8.4.7
Events of Clinical Interest
Selected serious and nonserious AEs are also known as ECIs and must be reported to the 
Sponsor.
Events of clinical interest for this study include:
1. An overdose of Sponsor’s product, as defined in Section 8.5.
2. Potential DILI events defined as an elevated AST or ALT laboratory value that is greater 
than or equal to 3× the ULN and an elevated total bilirubin laboratory value that is greater 
than or equal to 2× the ULN and, at the same time, an alkaline phosphatase laboratory 
value that is less than 2× the ULN, as determined by way of protocol-specified laboratory 
testing or unscheduled laboratory testing.*
*Note: These criteria are based on available regulatory guidance documents. The purpose 
of the criteria is to specify a threshold of abnormal hepatic tests that may require an 
additional evaluation for an underlying etiology. The study-site guidance for assessment 
and follow-up of these criteria can be found in the Investigator Study File Binder (or 
equivalent).
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It may also be appropriate to conduct additional evaluation for an underlying etiology in the 
setting of abnormalities of liver blood tests including AST, ALT, bilirubin, and alkaline 
phosphatase that do not meet the criteria noted above. In these cases, the decision to proceed 
with additional evaluation will be made through consultation between the study investigators 
and the Sponsor Clinical Director. However, abnormalities of liver blood tests that do not 
meet the criteria noted above are not ECIs for this study.
8.5
Treatment of Overdose
For purposes of this study, an overdose will be defined as any dose of any drug administered 
as part of the study exceeding the dose prescribed by the protocol. It is up to the investigator 
or the reporting physician to decide whether a dose is to be considered an overdose, in 
consultation with the Sponsor.
Sponsor does not recommend specific treatment for an overdose. Decisions regarding dose 
interruptions or modifications will be made by the investigator in consultation with the 
Sponsor Clinical Director based on the clinical evaluation of the participant.
8.6
Pharmacokinetics
The decision as to which plasma and/or urine samples collected will be measured for 
evaluation of PK/pharmacodynamics will be collaboratively determined by the Sponsor (eg, 
samples at lower doses may not be measured if samples at higher doses reveal undetectable 
drug concentrations). If indicated, these samples may also be measured and/or pooled for 
assay in an exploratory manner for metabolites and/or additional pharmacodynamic markers. 
Blood samples collected may be stored and further analysis may be performed, if required.
8.6.1
Blood Collection for Plasma MK-2060
Sample collection, storage, and shipment instructions for plasma samples will be provided in 
the Study Operations Manual by the Sponsor. 
8.7
Pharmacodynamics
Sample collection, storage, and shipment instructions for pharmacodynamic samples will be 
provided in the Study Operations Manual. Blood samples collected may be stored and further 
analysis may be performed, if required.
8.7.1
Blood Collection for PT, aPTT, FXI Activity
PT and aPTT at screening, predose, and postdose specified in the SoA will be performed 
locally for safety monitoring. All other predose and postdose PT and aPTT, as well as FXI 
activity will be performed at a central vendor for analysis. Sample collection, storage, and 
shipment instructions for the PT, aPTT, FXI activity will be provided in a separate Study 
Operations Manual by the Sponsor. The primary data for statistical analysis and modeling 
will be based on the information from the central vendor.
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8.7.2
Blood for Plasma ADA
Sample collection, storage, and shipment instructions for plasma samples will be provided in 
a separate Study Operations Manual by the Sponsor.
8.8
Biomarkers
Collection of samples for other biomarker research is also part of this study. The following 
samples for biomarker research are required and will be collected from all participants as 
specified in the SoA.
•
Blood for genetic analysis
8.8.1
Planned Genetic Analysis Sample Collection
The planned genetic analysis sample should be drawn for planned analysis of the association 
between genetic variants in DNA and drug response. This sample will not be collected at the 
site if there is either a local law or regulation prohibiting collection, or if the IRB/IEC does 
not approve the collection of the sample for these purposes. If the sample is collected, 
leftover extracted DNA will be stored for FBR if the participant provides documented 
informed consent for FBR. If the planned genetic analysis is not approved, but FBR is 
approved and consent is given, this sample will be collected for the purpose of FBR.
Sample collection, storage, and shipment instructions for planned genetic analysis samples 
will be in the Operations/Laboratory Manual.
8.9
Future Biomedical Research Sample Collection
If the participant provides documented informed consent for FBR, the following specimens 
will be obtained as part of FBR:
•
Leftover samples from Section 8.8.
8.10
Health Economics Medical Resource Utilization and Health Economics
Health Economics are not evaluated in this study.
8.11
Visit Requirements
Visit requirements are outlined in Section 1.3. Specific procedure-related details are provided 
in Section 8.
8.11.1
Screening
Approximately 4 weeks before intervention randomization, potential participants will be 
evaluated to determine that they fulfill the entry requirements as set forth in Section 5.
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Participants may be rescreened after consultation with the Sponsor. Rescreening should 
include all screening procedures listed in the SoA, including consent review. Rescreen 
procedures cannot be conducted the day prior to intervention randomization if there are 
Day -1 procedures planned per protocol.
8.11.2
Treatment Period
Refer to the Schedule of Activities (Section 1.3) and Administrative and General Procedures 
(Section 8.1).
After all predose procedures have been completed and it is confirmed that the participant 
meets eligibility; the participant will be given a participant ID bracelet and assigned a unique 
randomization number associated with a specific treatment as defined by a computer-
generated randomization schedule. Participants will report to the CRU prior to the scheduled 
day of dosing or time specified by the investigator. On the day of dosing, participants will 
fast from all food and drinks, except water, for at least 8 hours prior to until 2-hours 
poststudy drug administration when they will be given a light breakfast (see Section 5.3.1). 
Participants will be administered study intervention as indicated in Section 6. Participants 
who, on Day 1, have a significant acute illness or fever prior to the administration of study 
drug may be rescheduled.
8.11.3
Poststudy
Participants will be required to return to clinic approximately 90 days for Part 1, 130 days for 
Part 2, and 120 days for Part 3 after the last dose of study intervention for the poststudy visit. 
If the poststudy visit occurs fewer than 90/130/120 days after the last dose of study 
intervention, a subsequent follow-up telephone call should be made at 90/130/120 days post 
the last dose of study intervention to determine if any AEs have occurred since the poststudy 
clinic visit.
8.11.4
Participants Discontinued From Study Intervention but Continuing to be 
Monitored in the Study
At any point if a participant discontinues from treatment but continues to be monitored in the 
study, all study procedures specified in the SoA may be completed at the discretion of the 
investigator and with Sponsor agreement. The subset of study procedures completed will be 
communicated in a PCL.
CKD4 and CKD5 participants who experience disease progression and convert to ESKD on 
HD following administration of study intervention but prior to the post-study visit may 
continue to be monitored in the study per the visit requirements in the SoA.
8.11.5
Safety Phone Call Follow-Up
A safety follow-up phone call will be performed approximately 14 days after the poststudy 
visit (within the visit windows allowed per protocol). The safety follow-up phone call must 
be performed by appropriately trained study site staff. At the discretion of the investigator an 
in-person follow-up may be performed. If the initial call is unsuccessful, the study site should 
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make a total of 3 attempts. All attempts to contact the participants will be recorded in the 
source documents. The calls will facilitate the collection of relevant safety information. The 
participant will be interviewed to obtain information relating to AEs and SAEs. All safety 
information described by the participant must be documented in the source documents.
8.11.6
Critical Procedures Based on Study Objectives: Timing of Procedure
For this study, the blood sample for MK-2060 is the critical procedure.
At any post-dose time point, the blood sample for MK-2060 needs to be collected as close to 
the exact time point as possible. All other procedures should be completed as close to the 
prescribed/scheduled time as possible. Study procedures can be performed before or after the 
prescribed/scheduled time.
The order of priority can be changed during the study with joint agreement of the investigator 
and the Sponsor Clinical Director.
Any nonscheduled procedures required for urgent evaluation of safety concerns take 
precedence over all routine scheduled procedures.
The following variance in procedure collection times will be permitted.
•
Screening 2 procedures: up to additional 4 hours of scheduled time 
•
PK, Pharmacodynamic and Safety Collection as outlined in Table 7, Table 8, and Table 
9.
Table 7
Pharmacokinetic, Pharmacodynamic and Safety (Blood/Urine) Collection 
Windows for Part1
Pharmacokinetic, 
Pharmacodynamic, Safety
Collection
Pharmacokinetic, Pharmacodynamic, 
Safety Collection Window
0 to < 4 hours
5 min
4 - < 8 hours
15 min
8 - < 24 hours
30 min
24 hours - < 48 hours
60 min
48 hours - < 120 hours
2 hours
120 hours - ≤ 168 hours
24 hours
Day 11 + Day 14
1 Day
Day 21
2 Days
Day 28
3 Days
Day 60 + Day 90
5 Days
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Table 8
Pharmacokinetic, Pharmacodynamic and Safety (Blood/Urine) Collection 
Windows for Part 2
Pharmacokinetic, 
Pharmacodynamic, Safety
Collection
Pharmacokinetic, Pharmacodynamic, 
Safety Collection Window
0 to < 4 hours
5 min
Days 1, 2, 3, 4, 8, 15, 22, 23, and 
29
No flexible window for the scheduled 
day
Days 10 and 17
±1 Day
Day 26
+1 Day
Days 35, 42, 49 and 63
±2 Days
Days 81 and 111
±3 Days
Day 130
±7 Days
Table 9
Pharmacokinetic, Pharmacodynamic and Safety (Blood/Urine) Collection 
Windows for Part 3
Pharmacokinetic, 
Pharmacodynamic, Safety
Collection
Pharmacokinetic, Pharmacodynamic, 
Safety Collection Window
0 to < 4 hours
5 min
4 - < 8 hours
15 min
8 - < 24 hours
30 min
24 hours - < 48 hours
60 min
48 hours - < 120 hours
2 hours
120 hours - ≤ 168 hours
24 hours
Day 11 + Day 14
1 Day
Day 21
2 Days
Day 28
3 Days
Day 60 + Day 90 + Day 120
5 Days
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•
Part 1, 2, and 3 Day 1 predose standard safety evaluations: VS and ECG at 3 hours; 
laboratory safety tests and physical exam at 24 hours
•
Part 2 Days 8, 15, and 22 predose standard safety evaluations: VS, ECG, and laboratory 
safety tests at 3 hours.
•
Post-dose standard safety evaluations: VS, ECG, laboratory safety tests, and physical 
exam
-
Prior to 24-hours postdose may be obtained within 15 minutes of the theoretical 
sampling time
-
Between 24-hours and <48-hours postdose may be obtained within 1 hour of the 
theoretical sampling time
-
From 48-hours to <120-hours postdose may be obtained within 2 hours of the 
theoretical sampling time
Note: Visit windows defined by +/- X day(s) refers to calendar days.
8.11.7
Study Design/Dosing/Procedures Modifications Permitted Within Protocol 
Parameters
This is a Phase 1 assessment of MK-2060 in humans, and the PK, pharmacodynamic, and 
safety profiles of the compound are still being elucidated. This protocol is written with some 
flexibility to accommodate the inherent dynamic nature of Phase 1 clinical studies. 
Modifications to the dose, dosing regimen, and/or clinical or laboratory procedures currently 
outlined may be required to achieve the scientific goals of the study objectives and/or to 
ensure appropriate safety monitoring of the study participants.
As such, some alterations from the currently outlined dose and/or dosing regimen may be 
permitted based on newly available data, but the maximum daily dose may not exceed those 
currently outlined in the protocol.
•
Repeat of or decrease in the dose of the study intervention administered in any given 
period/panel/part
•
Addition of study pause
•
Instructions to take study intervention with or without food or drink may also be modified 
based on newly available data
•
Modification of the PK/pharmacodynamic sample processing and shipping details based 
on newly available data
The PK/pharmacodynamic sampling scheme currently outlined in the protocol may be 
modified during the study based on newly available PK or pharmacodynamic data (e.g., to 
obtain data closer to the time of peak plasma concentrations). If indicated, these collected 
samples may also be assayed in an exploratory manner for metabolites and/or additional 
pharmacodynamic markers.
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Up to additional 50 mL of blood may be drawn for safety, PK, and/or pharmacodynamic 
analyses. The total blood volume withdrawn from any single participant will not exceed the 
maximum allowable volume during his/her participation in the entire study (Appendix 8).
The timing of procedures for assessment of safety procedures (eg, VS, ECG, safety 
laboratory tests, etc.) may be modified during the study based on newly available data. 
Additional laboratory safety tests may be added to blood samples previously drawn to obtain 
additional safety information. These changes will not increase the number of study 
procedures for a given participant during his/her participation in the entire study.
It is understood that the current study may use some or none of the alterations described 
above. Any alteration made to this protocol to meet the study objectives must be detailed by 
the Sponsor in a letter to the Study File and forwarded to the investigator for retention. The 
letter may be forwarded to the IRB/IEC at the discretion of the investigator.
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9
STATISTICAL ANALYSIS PLAN
9.1
Statistical Analysis Plan Summary
This section contains a brief summary of the statistical analyses for this study. Full details 
can be found in the subsequent sections.
Safety
Summary statistics and plots will be generated for raw laboratory safety tests, ECGs, and/or 
VS as well as for change from baseline, as deemed clinically appropriate. Depending on the 
safety parameter, the difference from baseline will either be computed on the original scale 
(raw change from baseline) or on the log scale and back-transformed for reporting (percent 
change from baseline).
9.2
Responsibility for Analyses
The statistical analysis of the data obtained from this study will be conducted by, or under the 
direct auspices of, the Early Clinical Development Statistics Department in collaboration 
with the Quantitative Pharmacology and Pharmacometrics Department and Translational 
Pharmacology Department of the Sponsor.
If, after the study has begun, changes are made to the statistical analysis plan stated below, 
then these deviations to the plan will be listed, along with an explanation as to why they 
occurred, in the Clinical Study Report.
9.3
Hypotheses/Estimation
Objectives of the study are stated in Section 3.
9.4
Analysis Endpoints
Primary Endpoints
1. Primary endpoints are bleeding related AEs, AEs, and discontinuations due to AEs.
•
Pharmacokinetics: The pharmacokinetic variables of primary interest for MK-2060 are 
measurement of MK-2060 plasma AUC0-∞, AUC0-168, Cmax, C168, Tmax, terminal 
t1/2, CL/F and Vz/F
Part 1 Hypothesis:
The true geometric mean AUC0-∞ is at least 11300 nM*hr. This value is based on the 
preliminary modeling and simulation analyses using data form MK-2060 P001 and MK-2060 
P004.
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Secondary Endpoints
2. Pharmacodynamics: The pharmacodynamics variable of secondary interest is fold-change 
in baseline in aPTT values. Baseline is defined as the predose value.
Exploratory Endpoints:
Pharmacodynamics: The pharmacodynamics variables of exploratory interest are Factor XI 
activity levels and prothrombin time.
9.5
Analysis Populations
The following populations are defined for the analysis and reporting of data. All participants 
will be reported, and their data analyzed, according to the treatment(s) they actually received.
All Participants as Treated: The All Participants as Treated Population consists of all 
participants who received at least one dose of treatment.  This population will be used for 
assessments of safety and tolerability.
Per-Protocol (PP): The Per-Protocol Population consists of the set of data generated by the 
subset of participants who comply with the protocol sufficiently to ensure that these data will 
be likely to exhibit the effects of treatment, according to the underlying scientific model. 
Compliance covers such considerations as exposure to treatment, availability of 
measurements and absence of important protocol deviations.  Important protocol deviations 
will be identified to the extent possible prior to unblinding by individuals responsible for data 
collection/compliance, and its analysis and interpretation.  Any participants or data values 
excluded from analysis will be identified, along with their reason for exclusion, in the CSR.  
At the end of the study, all participants who are compliant with the study procedure as 
aforementioned and have available data from at least one treatment will be included in the 
Per-Protocol dataset.
9.6
Statistical Methods
Summary statistics and plots will be generated for raw laboratory safety tests, ECGs, and/or 
VS as well as for change from baseline, as deemed clinically appropriate.  For all endpoints 
descriptive summary will be provided. For categorical measurements, counts and percentage 
numbers will be provided. Similarly, for continuous measurements, mean, standard 
deviation, median, min, max will be provided. Depending on the safety parameter, the 
difference from baseline will either be computed on the original scale (raw change from 
baseline) or on the log scale and back-transformed for reporting (percent change from 
baseline) as appropriate. Values will be listed for each PK parameter (including Tmax and 
apparent terminal t1/2), and appropriate non-model based descriptive statistics will be 
provided: N (number of participants with non-missing data), arithmetic mean, standard 
deviation, arithmetic percent CV (calculated as 100*sqrt(exp(s2)-1), where s2 is the observed 
variance on the natural log-scale.)
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Descriptive statistics as well as appropriate plots will be displayed for aPTT fold change 
from baseline. Similar statistics will be provided for the fold changes in the exploratory 
endpoints such as PT and FXI activity levels.
To test the part 1 primary hypothesis, the posterior probability that the true geometric mean 
of AUC0-∞ after a single well-tolerated dose of MK-2060 in adult participants with CKD4 is 
at least 11345 nM*hr, will be calculated using a noninformative prior. The CV for AUC0-∞ 
is expected to be approximately 30% (assuming similar variability as in MK-2060 P004).  If 
this posterior probability exceeds 60%, then the primary research hypothesis will be 
supported.
Since Part 2 and Part 3 involves estimation, descriptive statistics (mean, median, standard 
deviation, min, max values) will be provided for primary and secondary endpoints.
9.7
Interim Analyses
No interim analysis is planned for this study.
9.8
Multiplicity
Since there is a single prespecified primary hypotheses, no adjustments for multiplicity are 
needed.
9.9
Sample Size and Power Calculations
For Part 1, approximately 12 participants will be enrolled for this study. Participants will be 
randomized in a 3:1 ratio to receive a single 30-mg SC dose of MK-2060 (n=9) or placebo 
(n=3). 
Thus, with all 9 participants in MK-2060 group completing the study and a posterior 
probability threshold of 60%, there is approximately 82% probability of supporting the 
primary hypothesis if the true geometric mean of AUC0-∞ is 12800 assuming CV=30% and 
natural log-normal distribution for AUC0-∞. We assume that at 30-mg dose SC dose, the true 
GM is 12800. A table with PP calculations with assumptions about various values of the true 
GM and with CV=30% is as follows:
True Geometric Mean
Probability of Go (%)
12500
75.6%
12600
77.9%
12700
80.3%
12800
82.4%
12900
84.4%
13000
86.2%
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10
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1
Code of Conduct for Interventional Clinical Trials
Merck Sharp & Dohme LLC, Rahway, NJ, USA (MSD)
I.
Introduction
A. Purpose
Merck Sharp & Dohme LLC, Rahway, NJ, USA (MSD), through its subsidiaries, 
conducts clinical trials worldwide to evaluate the safety and effectiveness of our 
products. As such, we are committed to designing, planning, conducting, analyzing, 
and reporting these trials in compliance with the highest ethical and scientific 
standards. Protection of participants in clinical trials is the overriding concern in the 
design and conduct of clinical trials. In all cases, MSD clinical trials will be 
conducted in compliance with MSD’s global standards, local and/or national 
regulations (including all applicable data protection laws and regulations), and 
International Council for Harmonisation Good Clinical Practice (ICH GCP) E6 and 
ICH General Considerations for Clinical Studies E8, and in accordance with the 
ethical principles that have their origin in the Declaration of Helsinki.
B. Scope
Highest ethical and scientific standards shall be endorsed for all clinical 
interventional investigations sponsored by MSD irrespective of the party (parties) 
employed for their execution (e.g., contract research organizations, collaborative 
research efforts). This Code is not intended to apply to trials that are observational in 
nature, or which are retrospective. Further, this Code does not apply to investigator-
initiated trials, which are not under the full control of MSD.
II. Scientific Issues
A. Trial Conduct
1. Trial Design
Except for pilot or estimation trials, clinical trial protocols will be hypothesis-
driven to assess safety, efficacy, and/or pharmacokinetic or pharmacodynamic 
indices of MSD or comparator products. Alternatively, MSD may conduct 
outcomes research trials, trials to assess or validate various endpoint measures, or 
trials to determine patient preferences, etc.
The design (i.e., participant population, duration, statistical power) must be 
adequate to address the specific purpose of the trial and shall respect the data 
protection rights of all participants, trial site staff and, where applicable, third 
parties. Input may be considered from a broad range of stakeholders, including 
patient advocacy groups/patients representing the trial population, caregivers, and 
healthcare providers to ensure operational feasibility. Trial design also includes 
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proactive identification of critical to quality factors utilizing a risk-based 
approach. Plans are then developed to assess and mitigate risks to those factors as 
appropriate during the trial. All trial protocols are and will be assessed for the 
need and capability to enroll underrepresented groups. Participants must meet 
protocol entry criteria to be enrolled in the trial.
2. Site Selection
MSD’s clinical trials are conducted globally in many different countries and in 
diverse populations, including people of varying age, race, ethnicity, gender, and 
accounting for other potential disease related factors. MSD selects investigative 
sites based on medical expertise, access to appropriate participants, adequacy of 
facilities and staff, previous performance in clinical trials, as well as budgetary 
considerations. Prior to trial initiation, sites are evaluated by MSD personnel (or 
individuals acting on behalf of MSD) to assess the ability to successfully conduct 
the trial. Individuals involved in trial conduct receive training commensurate with 
their role prior to their becoming involved in the trial.
Where appropriate, and in accordance with regulatory authority guidance, MSD 
will make concerted efforts to raise awareness of clinical trial opportunities in 
various communities. MSD will seek to engage underrepresented groups and 
those disproportionately impacted by the disease under study. MSD will support 
clinical trial investigators to enroll underrepresented groups and expand access to 
those who will ultimately use the products under investigation.
3. Site Monitoring/Scientific Integrity
Investigative trial sites are monitored to assess compliance with the trial protocol 
and Good Clinical Practice (GCP). MSD reviews clinical data for accuracy, 
completeness, and consistency. Data are verified versus source documentation 
according to standard operating procedures. Per MSD policies and procedures, if 
potential fraud, scientific/research misconduct, privacy incidents/breaches or 
Clinical Trial-related Significant Quality Issues are reported, such matters are 
investigated. When necessary, appropriate corrective and/or preventative actions 
are defined and regulatory authorities and/or ethics review committees are 
notified.
B. Publication and Authorship
Regardless of trial outcome, MSD commits to publish the primary and secondary 
results of its registered trials of marketed products in which treatment is assigned, 
according to the pre-specified plans for data analysis. To the extent scientifically 
appropriate, MSD seeks to publish the results of other analyses it conducts that are 
important to patients, physicians, and payers. Some early phase or pilot trials are 
intended to be hypothesis generating rather than hypothesis testing; in such cases, 
publication of results may not be appropriate since the trial may be underpowered and 
the analyses complicated by statistical issues such as multiplicity.
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MSD’s policy on authorship is consistent with the recommendations published by the 
International Committee of Medical Journal Editors (ICMJE). In summary, 
authorship should reflect significant contribution to the design and conduct of the 
trial, performance or interpretation of the analysis, and/or writing of the manuscript. 
All named authors must be able to defend the trial results and conclusions. MSD 
funding of a trial will be acknowledged in publications.
III.Participant Protection
A. Regulatory Authority and Ethics Committee Review (Institutional Review Board 
[IRB]/Independent Ethics Committee [IEC])
All protocols and protocol amendments will be submitted by MSD for regulatory 
authority acceptance/authorization prior to implementation of the trial or amendment, 
in compliance with local and/or national regulations.
The protocol, protocol amendment(s), informed consent form, investigator’s 
brochure, and other relevant trial documents must be reviewed and approved by an 
IRB/IEC before being implemented at each site, in compliance with local and/or 
national regulations and ICH Guidelines. Changes to the protocol that are required 
urgently to eliminate an immediate hazard and to protect participant safety may be 
enacted in anticipation of ethics committee approval. MSD will inform regulatory 
authorities of such new measures to protect participant safety, in compliance with 
local and/or national regulations.
B. Safety
The guiding principle in decision-making in clinical trials is that participant welfare is 
of primary importance. Potential participants will be informed of the risks and 
benefits of, as well as alternatives to, trial participation. At a minimum, trial designs 
will take into account the local standard of care.
All participation in MSD clinical trials is voluntary. Participants enter the trial only 
after informed consent is obtained. Trial designs include procedures and systems for 
the identification, monitoring, and reporting of safety concerns. Participants may 
withdraw from an MSD trial at any time, without any influence on their access to, or 
receipt of, medical care that may otherwise be available to them.
During trial planning, the need for an independent Data Monitoring Committee 
(DMC) is assessed. DMC review of data accumulated during the conduct of the trial 
is integral to the well-being of trial participants.
C. Confidentiality
MSD is committed to safeguarding participant confidentiality, to the greatest extent 
possible, as well as all applicable data protection rights. Unless required by law, only 
the investigator, Sponsor (or individuals acting on behalf of MSD), ethics committee, 
and/or regulatory authorities will have access to confidential medical records that 
might identify the participant by name.
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D. Genomic Research
Genomic research will only be conducted in accordance with a protocol and informed 
consent authorized by an ethics committee.
E. Trial Results
At the time of providing informed consent and in accordance with local laws and 
regulations, participants should be informed about the plans for availability of trial 
results.
IV.Financial Considerations
A. Payments to Investigators
Clinical trials are time- and labor-intensive. It is MSD’s policy to compensate 
investigators (or the sponsoring institution) in a fair manner for the work performed 
in support of MSD trials. MSD does not pay incentives to enroll participants in its 
trials. However, when enrollment is particularly challenging, additional payments 
may be made to compensate for the time spent in extra recruiting efforts.
MSD does not pay for participant referrals. However, MSD may compensate 
referring physicians for time spent on medical record review and medical evaluation 
to identify potentially eligible participants.
B. Clinical Research Funding
Informed consent forms will disclose that the trial is sponsored by MSD, and that the 
investigator or sponsoring institution is being paid or provided a grant for performing 
the trial. However, the local ethics committee may wish to alter the wording of the 
disclosure statement to be consistent with financial practices at that institution. As 
noted above, all publications resulting from MSD trials will indicate MSD as a source 
of funding.
C. Funding for Travel and Other Requests
Funding of travel by investigators and support staff (e.g., to scientific meetings, 
investigator meetings, etc) will be consistent with local guidelines and practices.
V. Investigator Commitment
Investigators will be expected to review MSD’s Code of Conduct as an appendix to the 
trial protocol, and in signing the protocol, agree to support these ethical and scientific 
standards.
10.1.2
Financial Disclosure
Financial disclosure requirements are outlined in the US Food and Drug Administration 
Regulations, Financial Disclosure by Clinical Investigators (21 CFR Part 54). It is the 
Sponsor’s responsibility to determine, based on these regulations, whether a request for 
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financial disclosure information is required. It is the investigator’s/subinvestigator’s 
responsibility to comply with any such request.
The investigator/subinvestigator(s) agree, if requested by the Sponsor in accordance with 21 
CFR Part 54, to provide his/her financial interests in and/or arrangements with the Sponsor to 
allow for the submission of complete and accurate certification and disclosure statements. 
The investigator/subinvestigator(s) further agree to provide this information on a 
Certification/Disclosure Form, frequently known as a financial disclosure form, provided by 
the Sponsor. The investigator/subinvestigator(s) also consent to the transmission of this 
information to the Sponsor in the United States for these purposes. This may involve the 
transmission of information to countries that do not have laws protecting personal data.
10.1.3
Data Protection
The Sponsor will conduct this study in compliance with all applicable data protection 
regulations.
Participants will be assigned a unique identifier by the Sponsor. Any participant records or 
datasets that are transferred to the Sponsor will contain the identifier only; participant names 
or any information that would make the participant identifiable will not be transferred.
The participant must be informed that his/her personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities.
10.1.3.1
Confidentiality of Data
By signing this protocol, the investigator affirms to the Sponsor that information furnished to 
the investigator by the Sponsor will be maintained in confidence, and such information will 
be divulged to the IRB, IEC, or similar or expert committee, affiliated institution, and 
employees, only under an appropriate understanding of confidentiality with such board or 
committee, affiliated institution, and employees. Data generated by this study will be 
considered confidential by the investigator, except to the extent that it is included in a 
publication as provided in the Publications section of this protocol.
10.1.3.2
Confidentiality of Participant Records
By signing this protocol, the investigator agrees that the Sponsor (or Sponsor representative), 
IRB/IEC, or regulatory authority representatives may consult and/or copy study documents to 
verify worksheet/CRF data. By signing the consent form, the participant agrees to this 
process. If study documents will be photocopied during the process of verifying 
worksheet/CRF information, the participant will be identified by unique code only; full 
names/initials will be masked before transmission to the Sponsor.
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By signing this protocol, the investigator agrees to treat all participant data used and 
disclosed in connection with this study in accordance with all applicable privacy laws, rules,
and regulations.
10.1.3.3
Confidentiality of IRB/IEC Information
The Sponsor is required to record the name and address of each IRB/IEC that reviews and 
approves this study. The Sponsor is also required to document that each IRB/IEC meets 
regulatory and ICH GCP requirements by requesting and maintaining records of the names 
and qualifications of the IRB/IEC members and to make these records available for 
regulatory agency review upon request by those agencies.
10.1.4
Committees Structure
Not applicable.
10.1.5
Publication Policy
The results of this study may be published or presented at scientific meetings. The Sponsor 
will comply with the requirements for publication of study results. In accordance with 
standard editorial and ethical practice, the Sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data. In this case, a 
coordinating investigator will be designated by mutual agreement.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all 
manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect 
proprietary information and to provide comments.
Authorship will be determined by mutual agreement and in line with ICMJE authorship 
requirements.
10.1.6
Compliance with Study Registration and Results Posting Requirements
Under the terms of the FDAAA of 2007 and the EMA clinical trials Regulation 536/2014, the 
Sponsor of the study is solely responsible for determining whether the study and its results 
are subject to the requirements for submission to http://www.clinicaltrials.gov, 
www.clinicaltrialsregister.eu, https://euclinicaltrials.eu, or other local registries. MSD, as 
Sponsor of this study, will review this protocol and submit the information necessary to 
fulfill these requirements. MSD entries are not limited to FDAAA or the EMA clinical trials 
Regulation 536/2014 mandated trials. Information posted will allow participants to identify 
potentially appropriate studies for their disease conditions and pursue participation by calling 
a central contact number for further information on appropriate study locations and study-site 
contact information.
By signing this protocol, the investigator acknowledges that the statutory obligations under 
FDAAA, the EMA clinical trials Regulation 536/2014, or other locally mandated registries 
are that of the Sponsor and agrees not to submit any information about this study or its results 
to those registries.
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10.1.7
Compliance with Law, Audit, and Debarment
By signing this protocol, the investigator agrees to conduct the study in an efficient and 
diligent manner and in conformance with this protocol; generally accepted standards of GCP 
(eg, ICH GCP: Consolidated Guideline and other generally accepted standards of GCP); and 
all applicable federal, state, and local laws, rules and regulations relating to the conduct of 
the clinical study.
The Code of Conduct, a collection of goals and considerations that govern the ethical and 
scientific conduct of clinical investigations sponsored by MSD, is provided in this appendix 
under the Code of Conduct for Clinical Trials.
The investigator agrees not to seek reimbursement from participants, their insurance 
providers, or from government programs for procedures included as part of the study 
reimbursed to the investigator by the Sponsor.
The investigator will promptly inform the Sponsor of any regulatory authority inspection 
conducted for this study.
The investigator agrees to provide the Sponsor with relevant information from inspection 
observations/findings to allow the Sponsor to assist in responding to any citations resulting 
from regulatory authority inspection and will provide the Sponsor with a copy of the 
proposed response for consultation before submission to the regulatory authority.
Persons debarred from conducting or working on clinical studies by any court or regulatory 
authority will not be allowed to conduct or work on this Sponsor’s studies. The investigator 
will immediately disclose in writing to the Sponsor if any person who is involved in 
conducting the study is debarred or if any proceeding for debarment is pending or, to the best 
of the investigator’s knowledge, threatened.
For investigators located in countries with serious breach reporting requirements, investigator 
will promptly report to the Sponsor any serious breach or suspected serious breach that 
occurs in compliance with those requirements. Unless more specifically defined in the 
applicable requirements, a serious breach is any breach of the applicable clinical trial 
regulation or of the clinical trial protocol which is likely to affect to a significant degree: (i) 
the safety or rights of a trial participant, or (ii) the reliability and robustness of the data 
generated in the clinical trial.
10.1.8
Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The investigator 
or qualified designee is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF.
Detailed information regarding Data Management procedures for this protocol will be 
provided separately.
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The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.
Study documentation will be promptly and fully disclosed to the Sponsor by the investigator 
upon request and also shall be made available at the study site upon request for inspection, 
copying, review, and audit at reasonable times by representatives of the Sponsor or any 
regulatory authorities. The investigator agrees to promptly take any reasonable steps that are 
requested by the Sponsor or any regulatory authorities as a result of an audit or inspection to 
cure deficiencies in the study documentation and worksheets/CRFs.
The Sponsor or designee is responsible for the data management of this study including 
quality checking of the data.
Study monitors will perform ongoing source data review and verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, complete, and verifiable from 
source documents; that the safety and rights of participants are being protected; and that the 
study is being conducted in accordance with the currently approved protocol and any other 
study agreements, ICH GCP, and all applicable regulatory requirements.
Records and documents, including participants’ documented informed consent, pertaining to 
the conduct of this study must be retained by the investigator for 15 years after study 
completion unless local regulations or institutional policies require a longer retention period. 
No records may be destroyed during the retention period without the written approval of the 
Sponsor. No records may be transferred to another location or party without written 
notification to the Sponsor.
10.1.9
Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. The investigator/institution should maintain adequate and 
accurate source documents and study records that include all pertinent observations on each 
of the site’s participants. Source documents and data should be attributable, legible, 
contemporaneous, original, accurate, and complete. Changes to source data should be 
traceable, should not obscure the original entry, and should be explained if necessary (eg, via 
an audit trail). Source documents are filed at the investigator’s site.
Data reported on the CRF or entered in the eCRF that are transcribed from source documents 
must be consistent with the source documents or the discrepancies must be explained. The 
investigator/institution may need to request previous medical records or transfer records, 
depending on the study. Also, current medical records must be available.
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10.1.10
Study and Site Closure
The Sponsor or its designee may stop the study or study-site participation in the study for 
medical, safety, regulatory, administrative, or other reasons consistent with applicable laws, 
regulations, and GCP.
In the event the Sponsor prematurely terminates a particular study site, the Sponsor or 
designee will promptly notify that study site’s IRB/IEC as specified by applicable regulatory 
requirement(s).
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10.2
Appendix 2: Clinical Laboratory Tests
•
The tests detailed in Table 10 will be performed by the local laboratory.
•
Protocol-specific requirements for inclusion or exclusion of participants are detailed in 
Section 5 of the protocol.
•
Additional tests may be performed at any time during the study as determined necessary 
by the investigator or required by local regulations.
Table 10
Protocol-required Safety Laboratory Assessments
Laboratory 
Assessments
Parameters
Hematology
Platelet Count 
RBC Indices:
MCV
MCH
%Reticulocytes
WBC count with 
Differential:
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils
RBC Count
Hemoglobin
Hematocrit
Chemistry
BUN
Potassium
AST/SGOT
Total bilirubin (and 
direct bilirubin if 
total bilirubin is 
above the upper 
limit of normal)
Albumin
Bicarbonate
Chloride
Phosphorous
Creatinine
Sodium
ALT/SGPT
Total Protein
Glucose 
Calcium
Alkaline 
phosphatase
Coagulation
aPTT, PT
Routine 
Urinalysis
•
Specific gravity
•
pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte 
esterase by dipstick
•
Microscopic examination (if blood or protein is abnormal)
Other Urine 
Tests
•
24-hour urine collection for urine protein
•
24-hour urine collection for urine creatinine
•
Spot urine protein: urine creatinine ratio
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Laboratory 
Assessments
Parameters
Other Screening 
Tests
•
FSH, as needed in WONCBP only
•
Alcohol and drug screen (to include at minimum: amphetamines, barbiturates, 
cocaine, opiates, cannabinoids, and benzodiazepines) 
•
Serology (HIV antibody, HBsAg, and hepatitis C virus antibody)
•
Serum β human chorionic gonadotropin (β hCG) pregnancy test (as needed for 
female participant)
ALT=alanine aminotransferase; AST=aspartate aminotransferase; BUN=blood urea nitrogen; FSH=follicle-
stimulating hormone; HBsAg=hepatitis B surface antigen; hCG=human chorionic gonadotropin; [HIV=human 
immunodeficiency virus]; MCH=mean corpuscular hemoglobin; MCV=mean corpuscular volume; RBC=red 
blood cell; SGOT=serum glutamic-oxaloacetic transaminase; SGPT=serum glutamic-pyruvic transaminase; 
ULN=upper limit of normal; WBC=white blood cell; WOCBP=women of childbearing potential; 
WONCBP=women of nonchildbearing potential
The investigator (or medically qualified designee) must document their review of each 
laboratory safety report.
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10.3
Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
10.3.1
Definitions of Medication Error, Misuse, and Abuse
Medication error
This is an unintended failure in the drug treatment process that leads to or has the potential to 
lead to harm to the patient.
Misuse
This refers to situations where the medicinal product is intentionally and inappropriately used 
not in accordance with the terms of the product information.
Abuse
This corresponds to the persistent or sporadic intentional, excessive use of a medicinal 
product for a perceived psychological or physiological reward or desired nontherapeutic 
effect.
10.3.2
Definition of AE
AE definition
•
An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of study intervention, whether or not considered related to the 
study intervention.
•
Note: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of a study intervention.
•
Note: For purposes of AE definition, study intervention includes any pharmaceutical 
product, biological product, vaccine, diagnostic agent, medical device, combination 
product, or protocol-specified procedure whether investigational or marketed (including 
placebo, active comparator product, or run-in intervention), manufactured by, licensed 
by, provided by, or distributed by the Sponsor for human use in this study.
Events meeting the AE definition
•
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the medical 
and scientific judgment of the investigator.
•
Exacerbation of a chronic or intermittent preexisting condition including either an 
increase in frequency and/or intensity of the condition.
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•
New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study.
•
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
•
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication.
•
For all reports of overdose (whether accidental or intentional) with an associated AE, the 
AE term should reflect the clinical symptoms or abnormal test result. An overdose 
without any associated clinical symptoms or abnormal laboratory results is reported using 
the terminology “accidental or intentional overdose without adverse effect.”
•
Any new cancer or progression of existing cancer.
Events NOT meeting the AE definition
•
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to 
the procedure is the AE.
•
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
•
Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present or 
detected at the start of the study that do not worsen.
•
Surgical procedure(s) planned prior to informed consent to treat a preexisting condition 
that has not worsened.
•
Refer to Section 8.4.6 for protocol-specific exceptions.
10.3.3
Definition of SAE
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met.
An SAE is defined as any untoward medical occurrence that, at any dose:
a.
Results in death
b. Is life-threatening
-
The term “life-threatening” in the definition of “serious” refers to an event in which 
the participant was at risk of death at the time of the event. It does not refer to an 
event, which hypothetically might have caused death, if it were more severe.
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c.
Requires inpatient hospitalization or prolongation of existing hospitalization
-
Hospitalization is defined as an inpatient admission, regardless of length of stay, even 
if the hospitalization is a precautionary measure for continued observation. (Note: 
Hospitalization for an elective procedure to treat a preexisting condition that has not 
worsened is not an SAE.) A preexisting condition is a clinical condition that is 
diagnosed prior to the use of an MSD product and is documented in the participant’s 
medical history.
d. Results in persistent or significant disability/incapacity
-
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.
-
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, 
and accidental trauma (eg, sprained ankle) that may interfere with or prevent 
everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
-
In offspring of participant taking the product regardless of time to diagnosis.
f.
Other important medical events
-
Medical or scientific judgment should be exercised in deciding whether SAE 
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 participant or may require medical or surgical intervention to prevent 1 
of the other outcomes listed in the above definition. These events should usually be 
considered serious.
-
Examples of such events include invasive or malignant cancers, intensive treatment in 
an emergency room or at home for allergic bronchospasm, blood dyscrasias, or 
convulsions that do not result in hospitalization, or development of drug dependency 
or drug abuse.
10.3.4
Additional Events Reported
Additional events that require reporting
In addition to the above criteria, AEs meeting either of the below criteria, although not 
serious per ICH definition, are reportable to the Sponsor.
•
Is a cancer.
•
Is associated with an overdose.
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10.3.5
Recording AE and SAE
AE and SAE recording
•
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory, and diagnostics reports) related to 
the event.
•
The investigator will record all relevant AE/SAE information on the AE 
CRFs/worksheets at each examination.
•
It is not acceptable for the investigator to send photocopies of the participant’s medical 
records to the Sponsor in lieu of completion of the AE CRF page.
•
There may be instances when copies of medical records for certain cases are requested by 
the Sponsor. In this case, all participant identifiers, with the exception of the participant 
number, will be blinded on the copies of the medical records before submission to the 
Sponsor.
•
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. In such cases, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE.
Assessment of intensity/toxicity
•
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, not when it is rated as severe.
•
The investigator will make an assessment of intensity for each AE and SAE (and other 
reportable safety event) reported during the study and assign it to 1 of the following 
categories:
-
Mild: An event that is easily tolerated by the participant, causing minimal discomfort, 
and not interfering with everyday activities (for pediatric studies, awareness of 
symptoms, but easily tolerated).
-
Moderate: An event that causes sufficient discomfort to interfere with normal 
everyday activities (for pediatric studies, definitely acting like something is wrong).
-
Severe: An event that prevents normal everyday activities. An AE that is assessed as 
severe should not be confused with an SAE. Severe is a category used for rating the 
intensity of an event; and both AE and SAE can be assessed as severe (for pediatric 
studies, extremely distressed or unable to do usual activities).
Assessment of causality
•
Did the Study intervention cause the AE?
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•
The determination of the likelihood that the Study intervention caused the AE will be 
provided by an investigator who is a qualified physician. The investigator’s signed/dated 
initials on the source document or worksheet that supports the causality noted on the AE 
form, ensures that a medically qualified assessment of causality was done. This initialed 
document must be retained for the required regulatory time frame. The criteria below are 
intended as reference guidelines to assist the investigator in assessing the likelihood of a 
relationship between the test product and the AE based upon the available information.
•
The following components are to be used to assess the relationship between the 
Study intervention and the AE; the greater the correlation with the components and 
their respective elements (in number and/or intensity), the more likely the Sponsor’s 
product caused the AE:
-
Exposure: Is there evidence that the participant was actually exposed to the Study 
intervention such as: reliable history, acceptable compliance assessment (pill count, 
diary, etc), expected pharmacologic effect, or measurement of drug/metabolite in 
bodily specimen?
-
Time Course: Did the AE follow in a reasonable temporal sequence from 
administration of the Study intervention? Is the time of onset of the AE compatible 
with a drug-induced effect (applies to studies with investigational medicinal product)?
-
Likely Cause: Is the AE not reasonably explained by another etiology such as 
underlying disease, other drug(s)/vaccine(s), or other host or environmental factors.
-
Dechallenge: Was the Study intervention discontinued or dose/exposure/frequency 
reduced?
◦
If yes, did the AE resolve or improve?
◦
If yes, this is a positive dechallenge.
◦
If no, this is a negative dechallenge.
(Note: This criterion is not applicable if: (1) the AE resulted in death or permanent disability; 
(2) the AE resolved/improved despite continuation of the Study intervention; (3) the study is 
a single-dose drug study; or (4) Study intervention(s) is/are only used 1 time.)
-
Rechallenge: Was the participant re-exposed to the Study intervention in this study?
◦
If yes, did the AE recur or worsen?
◦
If yes, this is a positive rechallenge.
◦
If no, this is a negative rechallenge.
(Note: This criterion is not applicable if: (1) the initial AE resulted in death or permanent 
disability, or (2) the study is a single-dose drug study; or (3) Study intervention(s) is/are used 
only 1 time.)
NOTE: IF A RECHALLENGE IS PLANNED FOR AN AE THAT WAS SERIOUS AND 
MAY HAVE BEEN CAUSED BY THE STUDY INTERVENTION, OR IF RE-
EXPOSURE TO THE STUDY INTERVENTION POSES ADDITIONAL POTENTIAL 
SIGNIFICANT RISK TO THE PARTICIPANT THEN THE RECHALLENGE MUST BE 
APPROVED IN ADVANCE BY THE SPONSOR CLINICAL DIRECTOR, AND IF 
REQUIRED, THE IRB/IEC.
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•
Consistency with study intervention profile: Is the clinical/pathological presentation of 
the AE consistent with previous knowledge regarding the Study intervention or drug class 
pharmacology or toxicology?
•
The assessment of relationship will be reported on the CRFs/worksheets by an 
investigator who is a qualified physician according to their best clinical judgment, 
including consideration of the above elements.
•
Use the following scale of criteria as guidance (not all criteria must be present to be 
indicative of a Study intervention relationship).
-
Yes, there is a reasonable possibility of Study intervention relationship:
◦
There is evidence of exposure to the Study intervention. The temporal sequence 
of the AE onset relative to the administration of the Study intervention is 
reasonable. The AE is more likely explained by the Study intervention than by 
another cause.
-
No, there is not a reasonable possibility of Study intervention relationship:
◦
Participant did not receive the Study intervention OR temporal sequence of the 
AE onset relative to administration of the Study intervention is not reasonable OR 
the AE is more likely explained by another cause than the Study intervention. 
(Also entered for a participant with overdose without an associated AE.)
•
The investigator must review and provide an assessment of causality for each AE/SAE 
and document this in the medical notes.
•
There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important 
that the investigator always make an assessment of causality for every event before the 
initial transmission of the SAE data to the Sponsor.
•
The investigator may change their opinion of causality in light of follow-up information 
and send an SAE follow-up report with the updated causality assessment.
•
The causality assessment is 1 of the criteria used when determining regulatory reporting 
requirements.
Follow-up of AE and SAE
•
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by Sponsor to 
elucidate the nature and/or causality of the AE or SAE as fully as possible. This may 
include additional laboratory tests or investigations, histopathological examinations, or 
consultation with other health care professionals.
•
New or updated information will be recorded in the CRF.
•
The investigator will submit any updated SAE data to the Sponsor within 24 hours of 
receipt of the information.
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10.3.6
Reporting of AEs, SAEs, and Other Reportable Safety Events to the Sponsor
AE, SAE, and other reportable safety event reporting to Sponsor via electronic data 
collection tool
•
The primary mechanism for reporting to the Sponsor will be the EDC tool.
-
Electronic reporting procedures can be found in the EDC data entry guidelines (or 
equivalent).
-
If the electronic system is unavailable for more than 24 hours, then the site will use 
the paper AE Reporting form.
-
Reference Section 8.4.1 for reporting time requirements.
•
The site will enter the SAE data into the electronic system as soon as it becomes 
available.
•
After the study is completed at a given site, the EDC tool will be taken off-line to prevent 
the entry of new data or changes to existing data.
•
If a site receives a report of a new SAE from a study participant or receives updated data 
on a previously reported SAE after the EDC tool has been taken off-line, then the site can 
report this information on a paper SAE form or by telephone (see next section).
•
Contacts for SAE reporting can be found in the Investigator Study File Binder (or 
equivalent).
SAE reporting to the Sponsor via paper CRF
•
If the EDC tool is not operational, facsimile transmission or secure email of the SAE 
paper CRF is the preferred method to transmit this information to the Sponsor.
•
In rare circumstances and in the absence of facsimile equipment, notification by 
telephone is acceptable with a copy of the SAE data collection tool sent by overnight 
mail or courier service.
•
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the SAE CRF pages within the designated reporting time frames.
•
Contacts and instructions for SAE reporting and paper reporting procedures can be found 
in the Investigator Study File Binder (or equivalent).
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10.4
Appendix 4: Medical Device and Drug–Device Combination Products: Product 
Quality Complaints/Malfunctions: Definitions, Recording, and Follow-up
Not applicable.
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10.5
Appendix 5: Contraceptive Guidance
10.5.1
Definitions
Women of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below):
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
•
Premenarchal
•
Premenopausal female with 1 of the following:
-
Documented hysterectomy
-
Documented bilateral salpingectomy
-
Documented bilateral oophorectomy
For individuals with permanent infertility due to an alternate medical cause other than the 
above (eg, Mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview.
•
Postmenopausal female
-
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause.
◦
A high FSH level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or HRT. 
However, in the absence of 12 months of amenorrhea, confirmation with two FSH 
measurements in the postmenopausal range is required.
-
Females on HRT and whose menopausal status is in doubt will be required to use one 
of the non-hormonal highly effective contraception methods if they wish to continue 
their HRT during the study. Otherwise, they must discontinue HRT to allow 
confirmation of postmenopausal status before study enrollment.
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Women of Nonchildbearing Potential (WONCBP)
Women in the following categories are considered WONCBP:
•
Premenopausal female with 1 of the following:
-
Documented hysterectomy
-
Documented bilateral salpingectomy
-
Documented bilateral oophorectomy
For individuals with permanent infertility due to an alternate medical cause other than the 
above (eg, Mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note:  Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview.
•
Postmenopausal female
-
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. 
◦
A high FSH level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or HRT. 
However, in the absence of 12 months of amenorrhea, confirmation with two FSH 
measurements in the postmenopausal range is required. 
-
Females on HRT and whose menopausal status is in doubt must discontinue HRT to 
allow confirmation of postmenopausal status before study enrollment.
10.5.2
Contraceptive Requirements
Contraceptives allowed during the study includea:
Highly Effective Contraceptive Methods That Have Low User Dependencyb
Failure rate of <1% per year when used consistently and correctly.
•
Progestogen- only contraceptive implantd
•
IUSe
•
Non-hormonal IUD
•
Bilateral tubal occlusion
•
Azoospermic partner (vasectomized or secondary to medical cause)
This is a highly effective contraception method provided that the partner is the sole male sexual partner of 
the WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of 
contraception should be used. A spermatogenesis cycle is approximately 90 days.
Note: Documentation of azoospermia for a male participant can come from the site personnel’s review of 
the participant’s medical records, medical examination, or medical history interview.
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Contraceptives allowed during the study includea:
Highly Effective Contraceptive Methods That Are User Dependentb
Failure rate of <1% per year when used consistently and correctly.
•
Combined (estrogen- and progestogen- containing) hormonal contraceptiond
- Oral
- Intravaginal
- Transdermal
- Injectable
•
Progestogen-only hormonal contraceptiond
- Oral
- Injectable
Sexual Abstinence
•
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study intervention. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle 
of the participant.
Methods That Are Not Considered Highly Effective
Failure rate of >1% per year when used consistently and correctly.
•
Progesterone-only hormonal contraception where inhibition of ovulation is not the primary mode of action
•
Male or female condom with or without spermicide
•
Cervical cap, diaphragm, or sponge with spermicide
•
A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double 
barrier methods).
a   Contraceptive use by men or women should be consistent with local regulations regarding the use of 
contraceptive methods for participants of clinical studies.
b   Typical use failure rates are higher than perfect-use failure rates (ie, when used consistently and correctly).
d   If locally required, in accordance with CTFG guidelines, acceptable hormonal contraceptives are limited to 
those which inhibit ovulation.
e   IUS is a progestin releasing IUD.
Note: The following are not acceptable methods of contraception:
-  Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus 
interruptus), spermicides only, and LAM.
-  Male and female condom should not be used together (due to risk of failure with friction).
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10.6
Appendix 6: Collection and Management of Specimens for Future Biomedical 
Research
1. Definitions
a.
Biomarker: A biological molecule found in blood, other body fluids, or tissues that is 
a sign of a normal or abnormal process or of a condition or disease. A biomarker may 
be used to see how well the body responds to a treatment for a disease or condition.1
b. Pharmacogenomics: The investigation of variations of DNA and RNA characteristics 
as related to drug/vaccine response.2
c.
Pharmacogenetics: A subset of pharmacogenomics, pharmacogenetics is the influence 
of variations in DNA sequence on drug/vaccine response.2
d. DNA: Deoxyribonucleic acid.
e.
RNA: Ribonucleic acid.
2. Scope of Future Biomedical Research3, 4
The specimens consented and/or collected in this study as outlined in Section 8.9 will be 
used in various experiments to understand:
-
The biology of how drugs/vaccines work
-
Biomarkers responsible for how a drug/vaccine enters and is removed by the body
-
Other pathways with which drugs/vaccines may interact
-
The biology of disease
The specimen(s) may be used for future assay development and/or drug/vaccine 
development.
It is now well recognized that information obtained from studying and testing clinical 
specimens offers unique opportunities to enhance our understanding of how individuals 
respond to drugs/vaccines, enhance our understanding of human disease, and ultimately 
improve public health through development of novel treatments targeted to populations 
with the greatest need. All specimens will be used by the Sponsor or those working for or 
with the Sponsor.
3. Summary of Procedures for Future Biomedical Research3, 4
a.
Participants for Enrollment
All participants enrolled in the clinical study will be considered for enrollment in 
future biomedical research.
b. Informed Consent
Informed consent for specimens (ie, DNA, RNA, protein, etc) will be obtained during 
screening for protocol enrollment from all participants or legal guardians, at a study 
visit by the investigator or his or her designate. Informed consent for future 
biomedical research should be presented to the participants on the visit designated in 
the SoA. If delayed, present consent at next possible Participant Visit. Consent forms 
signed by the participant will be kept at the clinical study site under secure storage for 
regulatory reasons.
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A template of each study site’s approved informed consent will be stored in the 
Sponsor’s clinical document repository.
c.
eCRF Documentation for Future Biomedical Research Specimens
Documentation of participant consent for future biomedical research will be captured 
in the eCRFs. Any specimens for which such an informed consent cannot be verified 
will be destroyed.
d. Future Biomedical Research Specimen(s)
Collection of specimens for future biomedical research will be performed as outlined 
in the SoA. In general, if additional blood specimens are being collected for future 
biomedical research, these will usually be obtained at a time when the participant is 
having blood drawn for other study purposes.
4. Confidential Participant Information for Future Biomedical Research3, 4
In order to optimize the research that can be conducted with future biomedical research 
specimens, it is critical to link participants’ clinical information with future test results. In 
fact, little or no research can be conducted without connecting the clinical study data to 
the specimen. The clinical data allow specific analyses to be conducted. Knowing 
participant characteristics like sex, age, medical history, and intervention outcomes is
critical to understanding clinical context of analytical results.
To maintain privacy of information collected from specimens obtained for future 
biomedical research, the Sponsor has developed secure policies and procedures. All 
specimens will be single coded per ICH E15 guidelines as described below.
At the clinical study site, unique codes will be placed on the future biomedical research 
specimens. This code is a random number that does not contain any personally 
identifying information embedded within it. The link (or key) between participant 
identifiers and this unique code will be held at the study site. No personal identifiers will 
appear on the specimen tube.
5. Biorepository Specimen Usage3, 4
Specimens obtained for the Sponsor will be used for analyses using good scientific 
practices. Analyses using the future biomedical research specimens may be performed by 
the Sponsor, or an additional third party (eg, a university investigator) designated by the 
Sponsor. The investigator conducting the analysis will follow the Sponsor’s privacy and 
confidentiality requirements. Any contracted third-party analyses will conform to the 
specific scope of analysis outlined in future biomedical research protocol and consent. 
Future biomedical research specimens remaining with the third party after specific 
analysis is performed will be reported to the Sponsor.
6. Withdrawal From Future Biomedical Research3, 4
Participants may withdraw their consent for FBR and ask that their biospecimens not be 
used for FBR. Participants may withdraw consent at any time by contacting the study 
investigator. If medical records for the study are still available, the investigator will 
contact the Sponsor using the designated mailbox 
(clinical.specimen.management@MSD.com). Subsequently, the participant's specimens 
will be flagged in the biorepository and restricted to study use only. If specimens were 
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collected from study participants specifically for FBR, these specimens will be removed 
from the biorepository and destroyed. Documentation will be sent to the investigator 
confirming withdrawal and/or destruction, if applicable. It is the responsibility of the 
investigator to inform the participant of completion of the withdrawal and/or destruction, 
if applicable. Any analyses in progress at the time of request for withdrawal/destruction 
or already performed before the request being received by the Sponsor will continue to be 
used as part of the overall research study data and results. No new analyses would be 
generated after the request is received.
If the medical records for the study are no longer available (eg, if the investigator is no 
longer required by regulatory authorities to retain the study records) or the specimens 
have been completely anonymized, there will no longer be a link between the 
participant’s personal information and their specimens. In this situation, the request for 
withdrawal of consent and/or destruction cannot be processed.
7. Retention of Specimens3, 4
Future biomedical research specimens will be stored in the biorepository for potential 
analysis for up to 20 years from the end of the study. Specimens may be stored for longer 
if a regulatory or governmental authority has active questions that are being answered. In 
this special circumstance, specimens will be stored until these questions have been 
adequately addressed.
Specimens from the study site will be shipped to a central laboratory and then shipped to 
the Sponsor-designated biorepository. If a central laboratory is not used in a particular 
study, the study site will ship directly to the Sponsor-designated biorepository. The 
specimens will be stored under strict supervision in a limited access facility, which 
operates to assure the integrity of the specimens. Specimens will be destroyed according 
to Sponsor policies and procedures and this destruction will be documented in the 
biorepository database.
8. Data Security3, 4
Databases containing specimen information and test results are accessible only to the 
authorized Sponsor representatives and the designated study administrator research 
personnel and/or collaborators. Database user authentication is highly secure, and is 
accomplished using network security policies and practices based on international 
standards to protect against unauthorized access.
9. Reporting of Future Biomedical Research Data to Participants3, 4
No information obtained from exploratory laboratory studies will be reported to the 
participant, family, or physicians. Principle reasons not to inform or return results to the 
participant include lack of relevance to participant health, limitations of predictive 
capability, and concerns regarding misinterpretation.
If important research findings are discovered, the Sponsor may publish results, present 
results in national meetings, and make results accessible on a public website in order to 
rapidly report this information to doctors and participants. Participants will not be 
identified by name in any published reports about this study or in any other scientific 
publication or presentation.
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10. Future Biomedical Research Study Population3, 4
Every effort will be made to recruit all participants diagnosed and treated on Sponsor 
clinical studies for future biomedical research.
11. Risks Versus Benefits of Future Biomedical Research3, 4
For future biomedical research, risks to the participant have been minimized and are 
described in the future biomedical research informed consent.
The Sponsor has developed strict security, policies, and procedures to address participant 
data privacy concerns. Data privacy risks are largely limited to rare situations involving 
possible breach of confidentiality. In this highly unlikely situation, there is risk that the 
information, like all medical information, may be misused.
12. Questions
Any questions related to the future biomedical research should be emailed directly to 
clinical.specimen.management@MSD.com.
13. References
1. National Cancer Institute [Internet]: Available from 
https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=45618
2. International Council on Harmonisation [Internet]: E15: Definitions for Genomic 
Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample 
Coding Categories. Available from 
http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/definitions-
for-genomic-biomarkers-pharmacogenomics-pharmacogenetics-genomic-data-and-
sample-cod.html
3. Industry Pharmacogenomics Working Group [Internet]: Understanding the Intent, 
Scope and Public Health Benefits of Exploratory Biomarker Research: A Guide for 
IRBs/IECs and Investigational Site Staff. Available at http://i-pwg.org/
4. Industry Pharmacogenomics Working Group [Internet]: Pharmacogenomics 
Informational Brochure for IRBs/IECs and Investigational Site Staff. Available at 
http://i-pwg.org/
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10.7
Appendix 7: Country-specific Requirements
Not applicable.
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10.8
Appendix 8: Blood Volume Tables
Part 1
Prestudy
Treatment 
Periods
Poststudy
Total 
Collections
mL Per 
Collection
Total 
mL/ Test
Laboratory Safety Tests
2
4
1
7
12.5
87.5
HIV/Hepatitis Screen (at the 
discretion of the investigator)
1
0
0
1
5
5
Blood for Planned Genetic 
Analysis
0
1
0
1
8.5
8.5
FSH (Females only)
1
0
0
1
3.5
3.5
Serum β-hCG pregnancy test 
(Females only)
1
1
1
3
3.5
10.5
Blood for plasma ADA and 
MK-2060
0
5
1
6
2.7
16.2
Blood for PT and aPTT at local 
lab
1
6
0
7
3
21
Blood for PT, aPTT, and Factor 
XI activity at central lab
0
12
1
13
10
130
Blood for MK-2060 only
0
7
0
7
1.8
12.6
Total Blood Volume per Male Participanta 280.8 mL
Total Blood Volume per Female Participanta 294.8 mL
ADA=anti-drug antibody; aPTT=activated partial thromboplastin time; hCG=human chorionic gonadotropin; 
HIV=human immunodeficiency virus; PT=prothrombin time
a If additional pharmacokinetic/pharmacodynamic and/or safety analysis is necessary, additional blood (no more than 
50 mL in total) may be obtained.
Part 2
Prestudy
Treatment 
Periods
Poststudy
Total 
Collections
mL Per 
Collection
Total 
mL/ Test
Laboratory Safety Tests
2
10
1
13
12.5
162.5
HIV/Hepatitis Screen (at the 
discretion of the investigator)
1
0
0
1
5
5
Blood for Planned Genetic 
Analysis
0
1
0
1
8.5
8.5
FSH (Females only)
1
0
0
1
3.5
3.5
Serum β-hCG pregnancy test 
(Females only)
1
2
1
4
3.5
14
Blood for plasma ADA and 
MK-2060
0
7
1
8
2.7
21.6
Blood for PT and aPTT at local 
lab
1
7
1
9
3
27
Blood for PT, aPTT, and Factor 
XI activity at central lab
0
16
1
17
10
170
Blood for MK-2060 only
0
9
0
9
1.8
16.2
Total Blood Volume per Male Participanta 410.8 mL
Total Blood Volume per Female Participanta 428.3 mL
ADA=anti-drug antibody; aPTT=activated partial thromboplastin time; hCG=human chorionic gonadotropin; 
HIV=human immunodeficiency virus; PT=prothrombin time
a If additional pharmacokinetic/pharmacodynamic and/or safety analysis is necessary, additional blood (no 
more than 50 mL in total) may be obtained.
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Part 3
Prestudy
Treatment 
Periods
Poststudy
Total 
Collections
mL Per 
Collection
Total 
mL/ Test
Laboratory Safety Tests
2
4
1
7
12.5
87.5
HIV/Hepatitis Screen (at the 
discretion of the investigator)
1
0
0
1
5
5
Blood for Planned Genetic 
Analysis
0
1
0
1
8.5
8.5
FSH (Females only)
1
0
0
1
3.5
3.5
Serum β-hCG pregnancy test 
(Females only)
1
1
1
3
3.5
10.5
Blood for plasma ADA and 
MK-2060
0
7
1
8
2.7
21.6
Blood for PT and aPTT at local 
lab
1
6
0
7
3
21
Blood for PT, aPTT, and Factor 
XI activity at central lab
0
14
1
15
10
150
Blood for MK-2060 only
0
7
0
7
1.8
12.6
Total Blood Volume per Male Participanta 306.2 mL
Total Blood Volume per Female Participanta 320.2 mL
ADA=anti-drug antibody; aPTT=activated partial thromboplastin time; hCG=human chorionic gonadotropin; 
HIV=human immunodeficiency virus; PT=prothrombin time
a If additional pharmacokinetic/pharmacodynamic and/or safety analysis is necessary, additional blood (no 
more than 50 mL in total) may be obtained.
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10.9
Appendix 9: Algorithm for Assessing Out of Range Laboratory Values
For all laboratory values obtained at pre-study (screening) visit and/or pre-dose evaluation:
a.
If all protocol-specified laboratory values are normal, the participant may enter the study.
b. If a protocol specified laboratory value is outside of the parameter(s) outlined in the 
inclusion/exclusion criteria (including a repeat if performed), the participant will be 
excluded from the study.
c.
If ≥1 protocol-specified laboratory value not specified in the inclusion/exclusion criteria 
is outside the normal range, the following choices are available:
a.
The participant may be excluded from the study.
b. The participant may be included in the study if the abnormal value(s) is NCS (the 
investigator must annotate the laboratory value “NCS” on the laboratory safety test 
source document).
c.
The participant may be included in the study if the abnormality is consistent with a 
pre-existing medical condition which is not excluded per protocol (e.g., elevated 
eosinophil count in a participant with asthma or seasonal allergies), the medical 
condition should be annotated on the laboratory report.
OR
d. The abnormal test may be repeated (refer items a. and b. below for continuation of 
algorithm for repeated values).
a.
If the repeat test value is within the normal range, the participant may enter the 
study.
b. If the repeat test value is still abnormal, the study investigator will evaluate the 
potential participant with a complete history and physical examination, looking 
especially for diseases that could result in the abnormal laboratory value in 
question. If such diseases can be ruled out, and if the abnormal laboratory value is 
not clinically relevant, then the participant may enter the study.
d. If there is any clinical uncertainty regarding the significance of an abnormal value, the 
participant will be excluded from the study.
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10.10 Appendix 10: Abbreviations
Abbreviation
Expanded Term
Ab
antibody
ACE
angiotensin converting enzyme
ADA
anti-drug antibodies
AE
adverse event 
ALP
alkaline phosphatase
ALT
alanine aminotransferase
aPTT
activated partial thromboplastin time
AS
anti-sense oligo
AST
aspartate aminotransferase
AUC
area under the concentration-time curve
AUC0-∞
area under the concentration-time curve extrapolated to infinity
AUC0-168
area under the concentration-time curve from 0 to 168 hours postdose
AUC0-last
area under the concentration-time curve to the last measurable 
concentration
AV
arteriovenous
AVG
arteriovenous graft
BMI
body mass index
BP
blood pressure
C
plasma concentration
C168
concentration at 168 hours
CCU
Critical Care Unit
CI
confidence interval
Cmax
maximum plasma concentration
CKD
Chronic Kidney Disease
CKD4
Stage 4 Chronic Kidney Disease
CKD5
Stage 5 Chronic Kidney Disease
CKD-EPI
Chronic Kidney Disease Epidemiology Collaboration
CL
clearance
CL/F
apparent total clearance
COVID-19
coronavirus of 2019
CrCl
creatinine clearance
CR
complete response
CRF
Case Report Form 
CRU
Clinical Research Unit
CSR
Clinical Study Report
CV
coefficient of variation
DBP
diastolic blood pressure
DDI
drug-drug interaction
DILI
drug-induced liver injury
DNA
deoxyribonucleic acid 
DPP-4
dipeptidyl peptidase-4
ECG
electrocardiogram 
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Abbreviation
Expanded Term
ECI
event of clinical interest
eCRF
electronic Case Report Form
EDC
electronic data collection 
eGFR
estimated glomerular filtration rate
EMA
European Medicines Agency
ER
Emergency Room
ESKD
End Stage Kidney Disease
ESKD-HD
End Stage Kidney Disease on Hemodialysis
FBR
future biomedical research
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act
FGA
Fibrin Generation Assay
FSH
follicle-stimulating hormone 
FXa
Factor Xa
FXI
Factor XI
FXIa
Factor XIa
GCP
Good Clinical Practice 
GCV
geometric coefficient of variation
GI
gastrointestinal
GLP-1
glucagon-like peptide 1
GM
geometric mean
GMR
geometric mean ratio
HBcAb
hepatitis B core antibody
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
hCG
human chorionic gonadotropin
HCV
hepatitis C virus
HD
hemodialysis
HIV
human immunodeficiency virus
HR
heart rate
IB
Investigator’s Brochure 
ICF
Informed Consent Form
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
ICU
Intensive Care Unit
IEC
Independent Ethics Committee
Ig
immunoglobulin
IgG4
immunoglobulin G4
IND
Investigational New Drug 
INR
International Normalized Ratio
IRB
Institutional Review Board
IUD
intrauterine device
IV
intravenous
IVIG
intravenous immune globulin
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Abbreviation
Expanded Term
LPI
last patient in
LPLV
last patient last visit
mAb
monoclonal antibody
MDRD
Modification of Diet in Renal Disease
NHV
normal healthy volunteer
NOAEL
no observed adverse effect level 
NSAID
nonsteroidal anti-inflammatory drug(s)
OTC
over-the-counter
P
protocol (number)
PCL
Protocol Clarification Letter
PK
pharmacokinetic
PI
principal investigator
PP
per-protocol
PR
PR interval
PT
prothrombin time
QTc
Q-T corrected (corrected Q-T interval)
QW
once weekly
RhoGAM
A brand of Rh immunoglobulin
RNA
ribonucleic acid
RR
respiratory rate
SAE
serious adverse event 
SBP
systolic blood pressure
SC
subcutaneous (ly)
SD
standard deviation
SGOT
serum glutamic oxaloacetic transaminase
SGPT
serum glutamic pyruvic transaminase
SoA
schedule of activities
SOC
standard of care
SOP
Standard Operating Procedures
SUSAR
suspected unexpected serious adverse reaction
t1/2
half life
Tmax
time to maximum plasma concentration
TGA
thrombin generation assay
THC
tetrahydrocannabinol
TMDD
target-mediated drug disposition
ULN
upper limit of normal
uPCR
urine protein to creatinine ratio
USP
United States Pharmacopeia
Vd 
volume of distribution
VS
vital signs
Vz/F
apparent volume of distribution
WOCBP
woman/women of childbearing potential
WONCBP
woman/women of nonchildbearing potential
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REFERENCES
[Bethune, C., et al 2017]
Bethune C, Walsh M, Jung B, Yu R, Geary 
RS, Bhanot S. Pharmacokinetics and 
pharmacodynamics of Ionis-FXI(RX), an 
antisense inhibitor of factor XI, in patients 
with end-stage renal disease on 
hemodialysis. Blood. 2017;130:1116.
[0559X2]
[Buller, H. R., et al 2015]
Buller HR, Bethune C, Bhanot S, Gailani D, 
Monia BP, Raskob GE, et al. Factor XI 
antisense oligonucleotide for prevention of 
venous thrombosis. N Engl J Med. 2015 Jan 
15;372(3):232-40.
[04T0MV]
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