CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
IW-3300 +1 moredrug
Likely dose
IW-3300 20 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05188261
NCT05188261Phase 1Completed
CompareCT.gov

A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered Single Ascending Doses of IW-3300 in Healthy Volunteers

Ironwood Pharmaceuticals, Inc.·interventional·Posted Jan 12, 2022·Updated Dec 8, 2023

In Brief

A Phase 1 clinical trial evaluating IW-3300 and Placebo for Healthy Volunteers. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJan 12, 2022
Enrollment StartJan 18, 2022
Primary CompletionMar 9, 2022
Study CompletionMar 21, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.5 years ago

Interventions

IW-3300drug

A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.

Placebodrug

A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.