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NCT05188261 · ClinicalTrials.gov registry record · Phase 1
A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Ironwood Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05188261: Completed Phase 1 study of Healthy Volunteers, sponsored by Ironwood Pharmaceuticals.
NCT05188261 is a Phase 1 study of Healthy Volunteers that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05188261, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Ironwood Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a first-in-human study to evaluate the safety and tolerability of single ascending doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema. Study participants will be randomized in a 3:1 ratio to receive a single dose of IW-3300 or placebo. Up to 5 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG IW-3300
Study Locations (1)
Texas
- PPD - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-01-18 |
| Est. Completion | 2022-03-21 |
| Phase | Phase 1 |
What the finished NCT05188261 record still lists
NCT05188261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05188261 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05188261 about?
NCT05188261 is a clinical study titled "A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers". This is a first-in-human study to evaluate the safety and tolerability of single ascending doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema. Study participants will be randomized in a 3:1 ratio to receive a single dose of IW-3300 or placebo. Up to 5 differ...
What is the current status of trial NCT05188261?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-01-18. Estimated completion is 2022-03-21.
What conditions does trial NCT05188261 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05188261?
The interventions under investigation include: Placebo (DRUG), IW-3300 (DRUG).
Who is sponsoring clinical trial NCT05188261?
This trial is sponsored by Ironwood Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05188261 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05188261's enrollment target sits among peer trials
32 171st of 283 higher than 99 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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