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NCT02875119 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
A Phase 1 study, sponsored by Population Council.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02875119 is a Phase 1 study that has completed, run by Population Council. The registered enrollment target is 15 participants.
The verdict
NCT02875119, a Phase 1 study, has completed, sponsored by Population Council.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design. Studies have demonstrated that GRFT is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.
Interventions
- DRUG Placebo Gel
- DRUG Griffithsin Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-10-01 |
| Est. Completion | 2018-09-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02875119
The ClinicalTrials.gov registry entry for NCT02875119 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Population Council, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo Gel is the first listed.
NCT02875119 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02875119 about?
NCT02875119 is a clinical study titled "Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women". This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design. Studies have demonstrated that GRFT is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-...
What is the current status of trial NCT02875119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-10-01. Estimated completion is 2018-09-01.
What interventions are being tested in trial NCT02875119?
The interventions under investigation include: Placebo Gel (DRUG), Griffithsin Gel (DRUG).
Who is sponsoring clinical trial NCT02875119?
This trial is sponsored by Population Council, which has 11 total clinical trials registered on ClinicalTrials.gov.
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