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CV8102

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

CV8102 · 1 trial · 1 indication

Phase 1 1
NCT02238756Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy AdultsRabies
COMPLETED72 Analytics
PHASE1COMPLETED
Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults
RabiesUnlock trial analytics

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 to 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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Frequently asked questions about CV8102

What is CV8102 used for?

CV8102 is an investigational monoclonal antibody being studied for use in rabies. It is currently in Phase 1 clinical development, with one completed trial in healthy adults. The drug is being developed by BioNTech SE (BNTX).

Who makes CV8102?

CV8102 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker BNTX. The drug is an investigational monoclonal antibody for rabies and is currently in Phase 1 clinical development.

What phase is CV8102 in?

CV8102 is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug is investigational and has not been approved for any use.

What clinical trials is CV8102 in?

CV8102 has been studied in one clinical trial, NCT02238756, titled 'Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults.' This Phase 1 trial was completed and enrolled 72 healthy male participants in Germany.

Is CV8102 a monoclonal antibody?

Yes, CV8102 is a monoclonal antibody. It is being investigated for the prevention or treatment of rabies. The drug is in Phase 1 clinical development, with one completed trial assessing its safety and tolerability in healthy adults.