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A Study of Multiple-ascending Doses of IW-3300 in 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
Summary
This trial tests IW-3300, a new drug given as a small enema, in healthy adults to check its safety and tolerability. The drug is administered rectally to see if it causes any side effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug through 24 hours post-day 1 dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug through 24 hours post-day 1 dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of Participants With Serious TEAEs
Side effects data
From 2022 Phase 1 trial • 32 Patients • NCT0518826117%
Myalgia
17%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
2500 μg IW-3300
300 μg IW-3300
Placebo
900 μg IW-3300
100 μg IW-3300
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
17,078 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