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NCT05362695 · ClinicalTrials.gov registry record · Phase 1
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
A Phase 1 study, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT05362695: Completed Phase 1 study, sponsored by Ironwood Pharmaceuticals.
NCT05362695 is a Phase 1 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05362695, a Phase 1 study, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This clinical study is designed as a multiple-ascending-dose, safety and tolerability study with IW-3300. The study drug will be administered as a low-volume \[20 mL\] enema. Study participants will be randomized in a 2:1 ratio to receive IW-3300 or placebo. Up to 3 different doses of IW-3300 will be studied. Safety reviews will be conducted before proceeding to each higher dose.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
Interventions
- DRUG Placebo
- DRUG IW-3300
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2022-07-13 |
| Phase | Phase 1 |
What the finished NCT05362695 record still lists
NCT05362695 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05362695 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05362695 about?
NCT05362695 is a clinical study titled "A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects". This clinical study is designed as a multiple-ascending-dose, safety and tolerability study with IW-3300. The study drug will be administered as a low-volume \[20 mL\] enema. Study participants will be randomized in a 2:1 ratio to receive IW-3300 or placebo. Up to 3 different doses of IW-3300 will b...
What is the current status of trial NCT05362695?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-05-17. Estimated completion is 2022-07-13.
What interventions are being tested in trial NCT05362695?
The interventions under investigation include: Placebo (DRUG), IW-3300 (DRUG).
Who is sponsoring clinical trial NCT05362695?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05362695's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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