Healthy VolunteersPhase 1NCT05188261
A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
A Phase 1 study testing IW-3300 in people with Healthy Volunteers, run by Ironwood Pharmaceuticals, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IW-3300
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 21 Mar 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and female subjects of non-childbearing potential
- Ages 18 to 60 years
- Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- 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).
- Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 (inclusive) at the Screening Visit.
- Male subjects and female partners are willing to use double-barrier method of contraception during the study.
- 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.
Who cannot join
- Evidence or history of clinically significant acute or chronic disease, or clinically significant illness within 30 days of the Screening Visit.
- History of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
- History of any condition that would interfere with their ability to receive an enema, or has had difficulty receiving an enema in the past.
- Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or history of inflammatory bowel disease.
- Used a prescription medication during the 14 days before Check-in
- Used any over-the-counter medications, including laxatives, and herbal supplements during the 7 days before Check-in.
Show all 14Show fewer
- Received a licensed or investigational vaccine during the 30 days before Check-in or is planning to receive any vaccine during the study.
- Recently received or donated blood products.
- 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).
- 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.
- Abnormal laboratory tests or clinically significant findings on safety tests conducted at the Screening Visit or at Check-in.
- Confirmed or suspected infection with COVID-19 at the Screening Visit or Check-in.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered Single Ascending Doses of IW-3300 in Healthy Volunteers
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.
Read the detailed description
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study assessing the safety, tolerability, and pharmacokinetics (PK) of IW 3300 administered rectally as a low-volume enema in healthy adult volunteers. This first-in-human study will assess participants for safety, tolerability, and PK.
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
- Healthy Volunteers
- Being tested
- IW-3300, Placebo
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 100 μg IW-3300 | Experimental | Dose 1: within the cohort, 6 participants receive active drug (IW-3300) Receives: Drug: IW-3300 |
| Cohort 1: Placebo | Placebo comparator | Within the cohort, 2 participants will receive the matching placebo dose Receives: Drug: Placebo |
| Cohort 2: 300 μg IW-3300 | Experimental | Dose 2: within the cohort, 6 participants receive active drug (IW-3300) Receives: Drug: IW-3300 |
| Cohort 2: Placebo | Placebo comparator | Within the cohort, 2 participants will receive the matching placebo dose Receives: Drug: Placebo |
| Cohort 3: 900 μg IW-3300 | Experimental | Dose 3: within the cohort, 6 participants receive active drug (IW-3300) Receives: Drug: IW-3300 |
| Cohort 3: Placebo | Placebo comparator | Within the cohort, 2 participants will receive the matching placebo dose Receives: Drug: Placebo |
| Cohort 4: 2500 μg IW-3300 | Experimental | Dose 4: within the cohort, 6 participants receive active drug (IW-3300) Receives: Drug: IW-3300 |
| Cohort 4: Placebo | Placebo comparator | Within the cohort, 2 participants will receive the matching placebo dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
Measured: From first dose of study drug through 24 hours post-Day 1 dose
Number of Participants With Serious TEAEs
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; or other situations such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. An SAE was considered a treatment-emergent SAE (serious TEAE) if the SAE started after initial study drug administration and within 1 day of the last dose of study drug.
Measured: From first dose of study drug through 24 hours post-Day 1 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start18 Jan 2022
- Primary completion9 Mar 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ironwood Study Chair, Study director, Ironwood Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188261
- Sponsor's protocol ID
- C3300-101
- Status last verified
- Mar 2023
- First submitted
- 17 Dec 2021
- Last updated
- 8 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered Single Ascending Doses of IW-3300 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05188261
- Acronym / sponsor ID
- C3300-101
- Conditions
- Healthy Volunteers
- Keywords
- healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ironwood Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Posted 8 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study assessing the safety, tolerability, and pharmacokinetics (PK) of IW 3300 administered rectally as a low-volume enema in healthy adult volunteers. This first-in-human study will assess participants for safety, tolerability, and PK.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 100 μg IW-3300 | Experimental | Drug: IW-3300Dose 1: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 1: Placebo | Placebo comparator | Drug: PlaceboWithin the cohort, 2 participants will receive the matching placebo dose |
| Cohort 2: 300 μg IW-3300 | Experimental | Drug: IW-3300Dose 2: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 2: Placebo | Placebo comparator | Drug: PlaceboWithin the cohort, 2 participants will receive the matching placebo dose |
| Cohort 3: 900 μg IW-3300 | Experimental | Drug: IW-3300Dose 3: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 3: Placebo | Placebo comparator | Drug: PlaceboWithin the cohort, 2 participants will receive the matching placebo dose |
| Cohort 4: 2500 μg IW-3300 | Experimental | Drug: IW-3300Dose 4: within the cohort, 6 participants receive active drug (IW-3300) |
| Cohort 4: Placebo | Placebo comparator | Drug: PlaceboWithin the cohort, 2 participants will receive the matching placebo dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and female subjects of non-childbearing potential
- Ages 18 to 60 years
- Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
- 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).
- Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 (inclusive) at the Screening Visit.
Key exclusion criteria (14 listed)
- Evidence or history of clinically significant acute or chronic disease, or clinically significant illness within 30 days of the Screening Visit.
- History of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
- History of any condition that would interfere with their ability to receive an enema, or has had difficulty receiving an enema in the past.
- Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or history of inflammatory bowel disease.
- Used a prescription medication during the 14 days before Check-in
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IW-3300A single dose of IW-3300 administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours. | Drug | Cohort 1: 100 μg IW-3300, Cohort 2: 300 μg IW-3300, Cohort 3: 900 μg IW-3300, Cohort 4: 2500 μg IW-3300 |
| PlaceboA single dose of placebo administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours. | Drug | Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo, Cohort 4: Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug through 24 hours post-Day 1 dose
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
Number of Participants With Serious TEAEs
Time frame: From first dose of study drug through 24 hours post-Day 1 dose
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; or other situations such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. An SAE was considered a treatment-emergent SAE (serious TEAE) if the SAE started after initial study drug administration and within 1 day of the last dose of study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ironwood Study Chair study director
Ironwood Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IW-3300 in people with Healthy Volunteers, run by Ironwood Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug through 24 hours post-Day 1 dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023; AzTrials last refreshed its copy on 7 Nov 2026.