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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: Completed Phase 1 study, sponsored by Population Council.
NCT02875119 is a Phase 1 study that has completed, run by Population Council. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the safety of PC-6500 gel used vaginally for a single dose; and then for 14 consecutive days of dosing. AEs will be coded in accordance with the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
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 |
What the finished NCT02875119 record still lists
NCT02875119 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Gel is the first listed.
NCT02875119 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02875119's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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