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AV0328

Phase 1

PNAG-expressing Pathogenic Microbes Vaccine | Monoclonal antibody | Other |Alopexx, Inc.|Trials Updated: Mar 19, 2019

AV0328 target and mechanism

ModalityMonoclonal antibody

Also known as AV0328 - Cohort 1, AV0328 - Cohort 2, AV0328 - Cohort 3, AV0328 - Cohort 4

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

AV0328 clinical trials

AV0328 · 1 trial · 1 indication

Phase 1 1
NCT02853617A Study of AV0328 Administered to Healthy Adult VolunteersPNAG-expressing Pathogenic Microbes Vaccine
COMPLETED16 Analytics
PHASE1COMPLETED
A Study of AV0328 Administered to Healthy Adult Volunteers
PNAG-expressing Pathogenic Microbes Vaccine
NCT0285361716
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Study Endpoints

Primary Endpoints

Number of patients with treatment-related adverse events (AEs) at Day 57 following AV0328 vaccination
Day 1 through Day 57

Continuous safety and tolerability monitoring of escalating doses of AV0328 in healthy adult volunteers at Day 57 with special attention to changes in bowel habits

Secondary Endpoints

Serologic evidence of efficacy of AV0328 against S. pneumoniae, N. meningitidis, and methicillin-resistant S. aureus at Day 57
Pre-dose, Days 29 and 57
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
AV0328 - Cohort 1EXPERIMENTALCohort 1 will receive 15 µg to be given as an IM injection
AV0328 - Cohort 2EXPERIMENTALCohorts 2 will receive 30 µg to be given as an IM injection
AV0328 - Cohort 3EXPERIMENTALCohorts 3 will receive 75 µg to be given as an IM injection
AV0328 - Cohort 4EXPERIMENTALCohorts 4 will receive 150 µg to be given as an IM injection

Interventions

NameTypeDescription
AV0328 - Cohort 1BIOLOGICALCohort 1 will receive 15 µg to be given as an IM injection
AV0328 - Cohort 2BIOLOGICALCohort 2 will receive 30 µg to be given as an IM injection
AV0328 - Cohort 3BIOLOGICALCohort 3 will receive 75 µg to be given as an IM injection
AV0328 - Cohort 4BIOLOGICALCohort 4 will receive 150 µg to be given as an IM injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy adult volunteer. 2. Age 18-55 years, inclusive. 3. Normal hematological, hepatic, and renal function. 4. Subjects participating in the study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterili...

Countries:United States
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