A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
NCT ID: NCT05188261
Last Updated: 2023-12-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2022-01-18
2022-03-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study includes up to 6 treatments: placebo and up to 5 dose levels of IW-3300 which will be determined after safety reviews of previous cohorts.
This study will enroll a maximum of 40 participants (up to 5 cohorts of 8 participants each). The 8 participants within each cohort will be randomized in a double-blind manner to receive a single dose of IW-3300 (6 participants) or placebo (2 participants), administered rectally as a low-volume \[20 mL\] enema. Each cohort will progress through a Screening Period, Clinic Period, and Follow-up Period. Treatment duration will be 1 day. Participants will remain in the Phase 1 unit for approximately 24 hours after dosing and will be contacted by phone for follow-up approximately 2 weeks after dosing. Total participation will be 22 to 45 days, including the Screening, Clinic, and Follow-up Periods.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: 100 μg IW-3300
Dose 1: within the cohort, 6 participants receive active drug (IW-3300)
IW-3300
A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Cohort 1: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Placebo
A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Cohort 2: 300 μg IW-3300
Dose 2: within the cohort, 6 participants receive active drug (IW-3300)
IW-3300
A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Cohort 2: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Placebo
A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Cohort 3: 900 μg IW-3300
Dose 3: within the cohort, 6 participants receive active drug (IW-3300)
IW-3300
A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Cohort 3: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Placebo
A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Cohort 4: 2500 μg IW-3300
Dose 4: within the cohort, 6 participants receive active drug (IW-3300)
IW-3300
A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Cohort 4: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Placebo
A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IW-3300
A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Placebo
A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Ages 18 to 60 years
3. Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
4. Normal bowel movement frequency of formed stool at baseline (≥3 per week and ≤3 per day; average Bristol stool form scale (BSFS) score of \>2 and \<6).
5. Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 (inclusive) at the Screening Visit.
6. Male subjects and female partners are willing to use double-barrier method of contraception during the study.
7. If subject is ≥45 years of age, subject is compliant with colorectal cancer screening guidelines according to the American College of Gastroenterology (ACG) Clinical Guidelines: Colorectal Cancer Screening 2021.
Exclusion Criteria
2. History of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
3. History of any condition that would interfere with their ability to receive an enema, or has had difficulty receiving an enema in the past.
4. Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or history of inflammatory bowel disease.
5. Used a prescription medication during the 14 days before Check-in
6. Used any over-the-counter medications, including laxatives, and herbal supplements during the 7 days before Check-in.
7. Received a licensed or investigational vaccine during the 30 days before Check-in or is planning to receive any vaccine during the study.
8. Recently received or donated blood products.
9. Undergone a surgical procedure during the 30 days before Check-in, other than minor dermatologic procedures, or has a history of surgery involving the GI tract or anal canal (with the exception of endoscopic procedures, appendectomy, and cholecystectomy).
10. Received any investigational drug during the 30 days or 5 half-lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study.
11. Abnormal laboratory tests or clinically significant findings on safety tests conducted at the Screening Visit or at Check-in.
12. Confirmed or suspected infection with COVID-19 at the Screening Visit or Check-in.
13. Positive serology for human immunodeficiency virus (HIV) 1, HIV 2, or hepatitis B surface antigen (HBsAg), or positive for anti-HIV 1, anti-HIV 2, or anti hepatitis C virus (HCV) antibodies at the Screening Visit.
14. History of alcohol or drug addiction during the year before the Screening Visit, or has a positive drug or alcohol screen at the Screening Visit or Check-in.
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ironwood Study Chair
Role: STUDY_DIRECTOR
Ironwood Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
PPD
Austin, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C3300-101
Identifier Type: -
Identifier Source: org_study_id