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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 is a Phase 1 study that has completed, run by Ironwood Pharmaceuticals. The registered enrollment target is 18 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG IW-3300

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2022-05-17
Est. Completion 2022-07-13
Phase Phase 1

Sponsor

Ironwood Pharmaceuticals

23 total trials

What the Registry Record Tells You About NCT05362695

The ClinicalTrials.gov registry entry for NCT05362695 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ironwood Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05362695 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.