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RIG-C

Phase 1

Rabies | Monoclonal antibody | Other |Grifols, S.A.|Last Updated: Jul 24, 2014

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02139657An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)PHASE1 COMPLETED 12Mar 1, 2014May 1, 2014Jul 24, 20141 United States
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Study Endpoints
Primary Endpoints
Rabies Virus Antibody Titer
10 days post-RIG-C dosing
Secondary Endpoints
Number of subjects who discontinue due to adverse events
21 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RIG-CEXPERIMENTALSingle 20 IU/kg dose of RIG-C by intramuscular injection
Interventions
NameTypeDescription
RIG-CBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * In good health in the judgment of the Investigator as determined by medical history, physical examination, and screening laboratory assessments. * Female of childbearing potential must have a negative result on the screening serum pregnancy test and must agree to practice cont...

Countries:United States
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