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NCT03082690 · ClinicalTrials.gov registry record · Phase 1
ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT03082690: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT03082690 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03082690, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
The purpose of this study is describe the safety and single-dose pharmacokinetics of rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess the luminal distribution of IQP-0528 in the rectum. Sixteen healthy volunteers will receive a single rectal dose of DuoGel, followed by blood, tissue and fluid sampling over the following 72 hours.
Primary Outcome
Grade 2 or above adverse events as measured by the Division of AIDS Toxicity Table
Interventions
- DRUG DuoGel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2019-06-02 |
| Phase | Phase 1 |
What the finished NCT03082690 record still lists
NCT03082690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which DuoGel is the first listed.
NCT03082690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03082690 about?
NCT03082690 is a clinical study titled "ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study". The purpose of this study is describe the safety and single-dose pharmacokinetics of rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess the luminal distribution of IQ...
What is the current status of trial NCT03082690?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2017-11-01. Estimated completion is 2019-06-02.
What interventions are being tested in trial NCT03082690?
The interventions under investigation include: DuoGel (DRUG).
Who is sponsoring clinical trial NCT03082690?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03082690's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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