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drugset / Trial / NCT02065973

An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101

NCT02065973 ↗

Phase 1 Completed 12 enrolled PDS Biotechnology Corp.
Non-randomizedFactorialOpen-labelTreatment

Summary

Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each based on a modified "3 + 3" dose-escalation study design. The study will be initiated with Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides. All subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and dose escalation will be based on safety evaluation for determination of potential dose-limiting toxicity (DLT).

Timeline

Start
2014-02
Primary completion
2015-12-30
Completion
2015-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride Unknown — Subcutaneous
Comparator Peptides from HPV-16 E6 and E7 Peptide — Subcutaneous

Indications

No indication recorded.