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IC47

Phase 1

Pneumococcal Infections | Monoclonal antibody | Infectious Disease |Valneva SE|Last Updated: Oct 19, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

IC47 · 1 trial · 1 indication

Phase 1 1
NCT00873431Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47Pneumococcal Infections
COMPLETED32 Analytics
PHASE1COMPLETED
Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
Pneumococcal Infections
NCT0087343132
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Study Endpoints

Primary Endpoints

Occurrence of any SAEs (possibly)related to the study vaccine
Day 0 - Day 264
Occurrence of any Grade 3 or higher adverse reactions (possibly)related to the study vaccine
Day 0 - Day 264
Occurrence of solicited local and systemic AEs within 1 week after vaccination
Day 0 - Day 264

Secondary Endpoints

Determination of vaccine-specific IgG levels
Day 0 - Day 264
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
IC47 30 mcgEXPERIMENTAL30 mcg with Alum
IC47 30 mcg w/oEXPERIMENTAL30 mcg without Alum
IC47 150 mcgEXPERIMENTAL150 mcg with Alum
IC47 150 mcg w/oEXPERIMENTAL150 mcg without Alum

Interventions

NameTypeDescription
IC47BIOLOGICALsolution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Written informed consent * Healthy adults ≥ 18 to \</= 65 * female subjects: post-menopausal or practicing reliable methods of contraception during the study Exclusion Criteria: * History of autoimmune diseases and malignancies. * History of severe hypersensitivity reactions...

Countries:Germany
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Frequently asked questions about IC47

What is IC47 used for?

IC47 is an investigational monoclonal antibody being developed for pneumococcal infections. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied for its safety, immunogenicity, and dose response in healthy volunteers.

What does IC47 target?

IC47 is a monoclonal antibody designed to target pneumococcal infections. As a monoclonal antibody, it is intended to bind to specific components of the pneumococcal bacteria to help the immune system fight the infection. The specific molecular target has not been disclosed.

Who is developing IC47?

IC47 is being developed by Valneva SE, a biopharmaceutical company listed on the stock exchange under the ticker VALN. Valneva is conducting clinical trials to evaluate the safety and immunogenicity of IC47 for the prevention or treatment of pneumococcal infections.

What phase is IC47 in?

IC47 is currently in Phase 1 clinical development. A Phase 1 trial has been completed, which assessed the safety, immunogenicity, and dose response of the drug in healthy volunteers. IC47 is still investigational and has not been approved for commercial use.

What clinical trials is IC47 in?

IC47 has one completed Phase 1 clinical trial registered under NCT00873431. This open-label, controlled study enrolled 32 participants in Germany to evaluate the safety, immunogenicity, and dose response of IC47 in healthy volunteers aged 18 years and older.