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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 is a Phase 1 study that has completed, run by PDS Biotechnology. The registered enrollment target is 12 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02065973
The ClinicalTrials.gov registry entry for NCT02065973 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PDS Biotechnology, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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