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CV8102

Phase 1

Rabies | Monoclonal antibody | Other |BioNTech SE|Last Updated: Jun 6, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02238756Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy AdultsPHASE1 COMPLETED 72Sep 1, 2014Nov 1, 2016Jun 6, 20181 Germany
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Study Endpoints
Primary Endpoints
Number of subjects with serious and non serious adverse events
Up to 12 months
Secondary Endpoints
Maximum tolerated dose (MTD) of CV8102 within the dose range of 25 µg to 250 µg.
Up to day 49
MTD of CV8102 in combination with rabies vaccine
Up to Day 49
Vaccination-elicited serum rabies VNTs among the dose groups
Up to day 35
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
CV8102EXPERIMENTAL -
RabipurACTIVE_COMPARATOR -
CV8102 + RabipurEXPERIMENTAL -
Interventions
NameTypeDescription
CV8102BIOLOGICALSubjects will receive 2 intramuscular doses of CV8102 given 21 days apart
RabipurBIOLOGICALSubjects will receive 2 intramuscular doses of Rabipur given 21 days apart
CV8102 + RabipurBIOLOGICALSubjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart
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Eligibility Criteria
Age Range18 Years — 40 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Compliant with protocol procedures and available for clinical F/U until the protocol-defined end of the trial 2. Physical examination and laboratory results without clinically significant findings 3. Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 4. Subjects must use reliable ...

Countries:Germany
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