Conditions: Anemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 61
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: COR-001 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document:
Prot_000.pdf: 
Cover Page for Protocol 
Sponsor name: 
Novo Nordisk A/S 
NCT number 
NCT02868229 
Sponsor trial ID: 
NN6018-4791 
Official title of study: 
A PKDVH 1/2 RDQGRPLVHG, DRXEOH-EOLQG, PODFHER-FRQWUROOHG, 
CRKRUW DRVH-HVFDODWLRQ SWXG\ LQ HHPRGLDO\VLV PDWLHQWV WR 
AVVHVV WKH6DIHW\PKDUPDFRNLQHWLFV, DQGPKDUPDFRG\QDPLFV 
RI MXOWLSOH IV 'RVHVRICOR-001 
Document date: 
20 November 2017 


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A PHASE 1/2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 
COHORT DOSE-ESCALATION STUDY IN HEMODIALYSIS PATIENTS TO 
ASSESS THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS
OF MULTIPLE IV DOSES OF COR-001 
DRUG NAME:
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PROTOCOL NUMBER:
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PHASE:
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TRIAL SPONSOR:
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MEDICAL MONITOR:
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PROTOCOL DATE:
AMENDMENT DATE:
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Confidentiality Statement
This protocol is the property of Corvidia Therapeutics. It is a confidential communication. Acceptance implies an 
agreement not to disclose information contained herein that is not otherwise publicly available, with the exception that 
it may be disclosed to an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) for the purpose of 
obtaining approval to conduct the study. The IRB/IEC is requested and expected to maintain confidentiality. This 
document may not be used or published without the consent of Corvidia Therapeutics.
This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be 
disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant 
parties.
 
 
 
 
 
Redacted protocol 
Includes redaction of personal identifiable information only. 
 
 
 
. 


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INVESTIGATOR’S AGREEMENT
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TABLE OF CONTENTS
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LIST OF APPENDICES
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PROTOCOL SYNOPSIS
Title
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Study Number
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Study Phase
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Objectives
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Study Design
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1
INTRODUCTION
1.1
Background 
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1.2
Description of COR-001 
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Figure 1 
A model for the influence of genetic variation on IL-6 –mediated 
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1.3
Summary of Relevant Nonclinical Experience with COR-001 
1.3.1
Non-Clinical Pharmacology 
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1.3.2
Pharmacokinetics in animals 
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Non-Clinical Toxicology and Safety 
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1.4
Summary of Relevant Clinical Experience
1.4.1
Phase 1 Study of COR-001 in Rheumatoid Arthritis Patients
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1.4.2
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3
INVESTIGATIONAL PLAN  
3.1
Overall Study Design and Plan: Description
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3.1.1
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3.1.2
Safety Endpoints 
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3.1.3
Pharmacodynamic Endpoints 
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3.3
Blinding and Randomization 
3.3.1
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3.3.3
Unblinding
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3.4
Duration of the Study
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3.5
Discussion of Study Design, Including Choice of Control Arm 
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3.5.1
Study Population and Control Arm
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3.5.2
Rationale for Dosing and Length of Safety Evaluation 
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3.5.3
Rationale for the Pharmacodynamic Endpoints 
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Rationale for the Dose Regimens 
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Table 1 
Exposures for Planned Doses and Safety Margins Relative to 
Toxicology Study 
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2 mg 
q14days 
6 mg 
q14days 
20 mg 
q14days 
60 mg 
q14days 
100 mg/kg
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1st dose
712
2138
7126
21379
2420000
last dose
1640
4920
16399
49197
3230000
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1st dose
268
803
2678
8032
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last dose
1042
3125
10417
31251
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502372
1674472
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111642743
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1st dose
3399
1132
340
113
last dose
1970
657
197
66
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222
67
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3.6
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4.3
Criteria for Discontinuation of Study Drug 
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4.4
Dose-Limiting Toxicities, Maximum Tolerated Dose, and Stopping Rules
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Study Completion 
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5
ENROLLMENT AND STUDY PROCEDURES
5.1
Patient Identification Numbers
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Screening Visit Procedures (Up to 2 weeks, Days -28 to -15) – Initial 
Screening
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Screening Visit Procedures (Days -14 to -1) – Full Screening 
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Laboratory Re-Testing and Re-Screening
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Treatment Period (Study Weeks 1 - 12) 
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Week 1, Day 1 (First Dose) 
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Week 1, Days 3 and 5 
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Week 2
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Week 3
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Week 5
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Week 6 
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Week 7 
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Week 8 
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Week 9
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Week 10
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5.4.13
Week 11, Day 75 
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5.4.14
Week 12/ET-1 
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5.5
Safety Follow-Up Period Procedures (Study Weeks 13 – 24) 
5.5.1
Weeks 14, 16, and 20 
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5.5.2
Weeks 18 and 24/ET-2 
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5.6
Extended Follow-Up Procedures (Study Week 35 ) 
5.6.1
Week 35 
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5.7
Unscheduled Visit
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5.8
Early Termination Visit
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5.8.1
Early Withdrawal from the Study 
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6
DRUG SUPPLIES AND DOSING
6.1.1
Dosing and Administration
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Table 2 
Planned COR-001 Doses, Serial Dilutions and Administered Volumes
Dose 
Cohort
Dosing Regimen
Drug Stock 
Concentration
(mg/mL in 
sterile water)
# of serial 
dilutions
(1 ml drug 
stock added 
to 2 ml from 
dilution vial 
for final 
volume of 
3 ml)
Diluted Drug 
Volume to be 
Used
(mL)
IVBP volume 
to be added to 
saline 
infusion bag
(in 100 ml 
saline)
Total Volume 
to be added to 
100mL 0.9% 
saline
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Figure 3 
A and B: Reconstitution and Serial Dilution of COR-001 for 
Administration
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6.1.2
Storage 
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6.1.3
Formulation and Packaging 
Table 3 
Composition for COR-001 for Injection, 50 mg/Vial
Ingredients
Quantity per vial
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50 mg
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1.9 mg
/+LVWLGLQHK\GURFKORULGHPRQRK\GUDWH
2.6 mg
7UHKDORVHGHK\GUDWH
85.0 mg
3RO\VRUEDWH
0.5 mg
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1.2 mL reconstitution volume
Table 4 
Composition for Placebo for Injection (3 mL vial) 
Ingredients
Quantity per vial
/+LVWLGLQH
1.9 mg
/+LVWLGLQHK\GURFKORULGHPRQRK\GUDWH
2.6 mg
7UHKDORVHGHK\GUDWH
85.0 mg
3RO\VRUEDWH
0.5 mg
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Table 5 
Composition IV Bag Protectant and Diluent (3 mL vial) 
Ingredients
Quantity per vial
6RGLXPFLWUDWH
11.3 mg
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1.2 mg
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139.1 mg
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6.2
Drug Accountability and Compliance
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PRIOR AND CONCOMITANT MEDICATIONS AND TREATMENTS
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Concomitant Medications and Treatments
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MANAGEMENT OF SPECIFIC ADVERSE EVENTS  
8.1
Serious Infections
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9
ADVERSE EVENT REPORTING
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Adverse Event Definitions 
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Serious Adverse Event Definition
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Adverse Events of Special Interest 
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9.5
Assessment of Severity
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9.6
Adverse Event Reporting
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Reporting of Serious Adverse Events and Adverse Events of Special 
Interest  
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Pregnancy Reporting
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10
STUDY ASSESSMENTS
10.1
Pharmacodynamic Assessments
10.1.1
Cardiac Magnetic Resonance Imaging for LV Mass Index 
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Handgrip Test 
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10.2
Safety Assessments (other than Adverse Events)
10.2.1
Vital Signs
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12-lead ECG 
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Physical Examination 
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Stool Occult Blood Testing
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10.2.5
Clinical Laboratory Testing 
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11
STATISTICAL CONSIDERATIONS AND DATA ANALYSIS
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11.1
Sample Size
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Randomization 
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11.3
General Statistical Considerations and Definitions
11.3.1
General Statistical Methods
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11.3.2
Analysis Populations
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11.3.3
Analysis Windows and Baseline 
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11.3.4
Missing Data Handling
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11.4
Statistical Analyses 
11.4.1
Demographic and Background Characteristics
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11.4.2
Study Drug and Concomitant Medications 
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11.4.3
Efficacy Analysis
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11.4.4
Efficacy Variables
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11.4.5
Safety Analysis

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11.4.6
Pharmacokinetic Analysis and Pharmacokinetic/Pharmacodynamic 
Analysis
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11.5
Interim Analyses
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12
STUDY COMMITTEES AND COMMUNICATIONS
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13
INVESTIGATOR AND ADMINISTRATIVE REQUIREMENTS
13.1
Institutional Review Board or Independent Ethics Committee
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13.2
Informed Consent
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13.3
Supplementary Documentation
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13.4
Data Reporting and Case Report Forms 
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13.5
Retention of Data
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13.6
Deviation from the Protocol 
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13.7
Study Monitoring
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13.8
Drug Accountability
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13.9
Disclosure of Data
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14
REFERENCES
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15
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Schedule of Events
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Schedule of Events for the Screening Period 
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Schedule of Events for the Treatment Period – Weeks 1 through 6 
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ESA and Parenteral Iron Dose-Adjustments 
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Laboratory Measurements 
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