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Study Protocol, Including Amendment Document Type: Study Protocol, including Amendment (Informed Consent Template located in Appendix I of the Protocol Version 1.0 and Version 2.0) Official Title: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults NCT Number: NCT03478891 Document/Date: Protocol Amendment Version 2.0: April 6, 2018 Protocol Version 1.0: February 21, 2018 Version 2.0 April 6, 2018 VACCINE RESEARCH CENTER Protocol VRC 608 (NIH 18-I-0069) A PHASE I, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF A HUMAN MONOCLONAL ANTIBODY, VRC-EBOMAB092-00-AB (MAB114), ADMINISTERED INTRAVENOUSLY TO HEALTHY ADULTS Study Product Provided by: Vaccine Research Center (VRC) National Institute of Allergy and Infectious Diseases (NIAID) National Institutes of Health (NIH) Bethesda, MD Clinical Trial Sponsored by: NIAID/VRC/NIH, Bethesda, Maryland IND 138,090 Sponsored by: VRC/NIAID/NIH, Bethesda, Maryland Principal Investigator: Martin Gaudinski, MD VRC/NIAID/NIH Bethesda, MD 20892 IRB Initial Review Date: January 8, 2018 PRODUCT: VRC-EBOMAB092-00-AB (MAb114) PROTOCOL: VRC 608, VERSION 2.0 PROTOCOL DATE: APRIL 6, 2018 TABLE OF CONTENTS Page ABBREVIATIONS....................................................................................................................... 5 PRÉCIS.......................................................................................................................................... 8 1. INTRODUCTION............................................................................................................. 9 1.1 Study Rationale................................................................................................................... 9 Passive Immunization with an Ebola-specific Antibody: MAb114......................... 9 Rationale for Dose and Administration Route Selection...................................... 10 1.2 MAb114 Specific Research Laboratory Assessments ...................................................... 10 1.3 Preclinical Toxicology Study of VRC-EBOMAB092-00-AB (MAb114) ....................... 11 1.4 In Vitro Safety Studies...................................................................................................... 11 1.5 Non-Human Primate (NHP) Studies of VRC-EBOMAB092-00-AB (MAb114) ............ 12 1.6 Previous Human Experience............................................................................................. 12 2. STUDY PRODUCT ........................................................................................................ 12 3. STUDY OBJECTIVES................................................................................................... 13 3.1 Primary Objectives............................................................................................................ 13 3.2 Secondary Objectives........................................................................................................ 13 3.3 Exploratory Objectives ..................................................................................................... 13 4. STUDY DESIGN............................................................................................................. 14 4.1 Study Population............................................................................................................... 14 Inclusion Criteria.................................................................................................. 14 Exclusion Criteria................................................................................................. 15 4.2 Clinical Procedures and Laboratory Assays ..................................................................... 16 Screening............................................................................................................... 16 Enrollment, Study Days and Visit Numbers.......................................................... 16 Administration of MAb114.................................................................................... 17 Solicited Adverse Events and Clinical Follow-up ................................................ 17 Pharmacokinetics.................................................................................................. 18 Schedule of Evaluations........................................................................................ 18 Concomitant Medications..................................................................................... 18 4.3 Criteria for Dose Escalation.............................................................................................. 18 4.4 Criteria for Discontinuing Study Participation ................................................................. 19 4.5 Criteria for Pausing the Study and Resuming the Study .................................................. 19 5. SAFETY AND ADVERSE EVENT REPORTING..................................................... 20 5.1 Adverse Events ................................................................................................................. 20 5.2 Serious Adverse Events .................................................................................................... 20 5.3 Adverse Event Reporting to the IND Sponsor.................................................................. 20 IND Sponsor Reporting to the FDA...................................................................... 21 5.4 Reporting to the Institutional Review Board .................................................................... 21 Unanticipated Problem (UP) Definition............................................................... 21 Protocol Deviation Definition............................................................................... 22 Non-Compliance Definition.................................................................................. 22 Page 2 of 53 PRODUCT: VRC-EBOMAB092-00-AB (MAb114) PROTOCOL: VRC 608, VERSION 2.0 PROTOCOL DATE: APRIL 6, 2018 Expedited Reporting to the IRB ............................................................................ 22 Annual Reporting to the IRB................................................................................. 23 6. STATISTICAL CONSIDERATIONS .......................................................................... 23 6.1 Overview........................................................................................................................... 23 6.2 Objectives ......................................................................................................................... 23 6.3 Size and Accrual ............................................................................................................... 23 Sample Size Considerations.................................................................................. 23 6.4 Statistical Analysis............................................................................................................ 25 Analysis Variables ................................................................................................ 25 Baseline Demographics ........................................................................................ 25 Safety Analysis ...................................................................................................... 25 Tolerability Evaluation......................................................................................... 26 Pharmacokinetics Analysis ................................................................................... 26 Interim Analyses.................................................................................................... 27 7. PHARMACY PROCEDURES ...................................................................................... 27 7.1 Study Product and Administration Regimen .................................................................... 27 7.2 Study Product Storage....................................................................................................... 27 7.3 Preparation of Study Product for Administration ............................................................. 28 7.4 Labeling of Study Product ................................................................................................ 29 7.5 Study Product Accountability........................................................................................... 29 7.6 Study Product Disposition ................................................................................................ 29 8. HUMAN SUBJECT PROTECTIONS AND ETHICAL OBLIGATIONS ............... 29 8.1 Informed Consent.............................................................................................................. 29 8.2 Risks and Benefits............................................................................................................. 29 Risks ...................................................................................................................... 29 Benefits.................................................................................................................. 30 8.3 Institutional Review Board ............................................................................................... 30 8.4 Subject Confidentiality ..................................................................................................... 31 8.5 Plan for Use and Storage of Biological Samples.............................................................
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