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

> **NCT02065973** · PHASE1 · COMPLETED · sponsor: **PDS Biotechnology Corp.** · enrollment: 12 (actual)

## Conditions studied

- High-risk HPV Infection and Biopsy-proven CIN1

## Interventions

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

## Key facts

- **NCT ID:** NCT02065973
- **Lead sponsor:** PDS Biotechnology Corp.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2014-02
- **Primary completion:** 2015-12-30
- **Final completion:** 2015-12-30
- **Target enrollment:** 12 (ACTUAL)
- **Last updated:** 2018-12-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02065973

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02065973, "An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101". Retrieved via AI Analytics 2026-08-19 from https://api.ai-analytics.org/clinical/NCT02065973. Licensed CC0.

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