NCT02065973

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

An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101 in Subjects With Cervical Intraepithelial Neoplasia (CIN) and High-risk Human Papillomavirus (HPV) Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: PDS Biotechnology Corp. · Industry
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• High-risk HPV Infection and Biopsy-proven CIN1

Interventions

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

Timeline

• Start date: 2014-02-01
• Primary completion: 2015-12-30
• Completion: 2015-12-30
• First posted: 2014-02-19
• Last updated: 2018-12-13

Locations

2 sites across 1 country: United States