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Cohort 1: 100 μg IW-3300 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Ironwood Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug through 24 hours post-day 1 dose
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug through 24 hours post-day 1 dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug through 24 hours post-day 1 dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of Participants With Serious TEAEs

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05188261
17%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
100 μg IW-3300
300 μg IW-3300
900 μg IW-3300
2500 μg IW-3300
Placebo

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 3 (optional): Dose 3Experimental Treatment1 Intervention
Active drug (IW-3300) once daily for 7 days
Group II: Cohort 2: 300 μg IW-3300Experimental Treatment1 Intervention
300 μg dose of active drug (IW-3300) once daily for 7 days
Group III: Cohort 1: 100 μg IW-3300Experimental Treatment1 Intervention
100 μg dose of active drug (IW-3300) once daily for 7 days
Group IV: Cohort 3 (optional): PlaceboPlacebo Group1 Intervention
Matching placebo once daily for 7 days
Group V: Cohort 1: PlaceboPlacebo Group1 Intervention
matching placebo once daily for 7 days
Group VI: Cohort 2: PlaceboPlacebo Group1 Intervention
matching placebo once daily for 7 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IW-3300
2022
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ironwood Pharmaceuticals, Inc.Lead Sponsor
41 Previous Clinical Trials
17,011 Total Patients Enrolled
Ironwood Study ChairStudy DirectorIronwood Pharmaceuticals
2 Previous Clinical Trials
274 Total Patients Enrolled
George Dukes, PharmDStudy DirectorIronwood Pharmaceuticals
1 Previous Clinical Trials
32 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
2022. "A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05362695.
~6 spots leftby Apr 2025
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