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NCT02065973 · ClinicalTrials.gov registry record · Phase 1
An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101
A Phase 1 study, sponsored by PDS Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT02065973: Completed Phase 1 study, sponsored by PDS Biotechnology.
NCT02065973 is a Phase 1 study that has completed, run by PDS Biotechnology. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02065973, a Phase 1 study, has completed, sponsored by PDS Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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).
Interventions
- BIOLOGICAL R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-12-30 |
| Phase | Phase 1 |
What the finished NCT02065973 record still lists
NCT02065973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7 is the first listed.
NCT02065973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02065973 about?
NCT02065973 is a clinical study titled "An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101". 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" do...
What is the current status of trial NCT02065973?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2014-02. Estimated completion is 2015-12-30.
What interventions are being tested in trial NCT02065973?
The interventions under investigation include: R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02065973?
This trial is sponsored by PDS Biotechnology, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02065973's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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