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R-enantiomer of 1, 2-dioleoyl-3-trimethylammonium-propane chloride+ Peptides from HPV-16 E6 and E7

Phase 1

High-risk HPV Infection and Biopsy-proven CIN1 | Monoclonal antibody | Infectious Disease |PDS Biotechnology Corporation|Last Updated: Dec 13, 2018

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

R-enantiomer of 1, 2-dioleoyl-3-trimethylammonium-propane chloride+ Peptides from HPV-16 E6 and E7 · 1 trial · 1 indication

Phase 1 1
NCT02065973An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101High-risk HPV Infection and Biopsy-proven CIN1
COMPLETED12 Analytics
PHASE1COMPLETED
An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101
High-risk HPV Infection and Biopsy-proven CIN1
NCT0206597312
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Study Endpoints

Primary Endpoints

Evaluation or determination of adverse events following vaccination
Days 1-133
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1 (Low Dose)ACTIVE_COMPARATORThe group will receive the lowest dose of the vaccine
Cohort 2 (Mid Dose)ACTIVE_COMPARATORThe Group will receive the middle dose of the vaccine
Cohort 3 (High Dose)ACTIVE_COMPARATORThe Group will receive the highest dose of vaccine to be tested

Interventions

NameTypeDescription
R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7BIOLOGICAL -
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Eligibility Criteria

Age Range21 Years to 65 Years
SexFEMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Written informed consent prior to initiation of any study-related procedures; 2. Nonlactating female between the ages of 21 to 65 years, inclusive; 3. Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contrac...

Countries:United States
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