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R-enantiomer of 1

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

Ensayo de PDS Biotechnology Corp en High-risk HPV Infection and Biopsy-proven CIN1 (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

12

previstos

Centros

2

Fin del objetivo primario

dic 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en feb 2014.

Qué mide

Evaluation or determination of adverse events following vaccination (Days 1-133) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPhase 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).

Más ensayos de PDSB

Todos los de PDSB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02065973), actualizada en dic 2018.