CompletedNCT05188261Updated Dec 8, 2023Results posted

A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers

A Phase 1 interventional study of IW-3300 and Placebo in Healthy Volunteers, sponsored by Ironwood Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-08.

Sponsored by Ironwood Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 32
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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. 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 studied

Healthy Volunteers

Keywords

healthy volunteers

In context

Lead sponsor

Ironwood Pharmaceuticals, Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 32 participants (actual)

Study arms

Experimental
Cohort 1: 100 μg IW-3300
Dose 1: within the cohort, 6 participants receive active drug (IW-3300)
Drug: IW-3300
Placebo comparator
Cohort 1: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Drug: Placebo
Experimental
Cohort 2: 300 μg IW-3300
Dose 2: within the cohort, 6 participants receive active drug (IW-3300)
Drug: IW-3300
Placebo comparator
Cohort 2: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Drug: Placebo
Experimental
Cohort 3: 900 μg IW-3300
Dose 3: within the cohort, 6 participants receive active drug (IW-3300)
Drug: IW-3300
Placebo comparator
Cohort 3: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Drug: Placebo
Experimental
Cohort 4: 2500 μg IW-3300
Dose 4: within the cohort, 6 participants receive active drug (IW-3300)
Drug: IW-3300
Placebo comparator
Cohort 4: Placebo
Within the cohort, 2 participants will receive the matching placebo dose
Drug: Placebo

Interventions

DrugIW-3300
A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
DrugPlacebo
A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: From first dose of study drug through 24 hours post-Day 1 dose

Results

Posted Dec 8, 2023

Participant flow

The study was designed to include up to 5 cohorts with 8 participants per cohort. Within each cohort, participants were randomized to receive a single dose of IW-3300 (6 participants) or placebo (2 participants). Doses to be evaluated were 100, 300, 900, and 2500 μg. An optional 5th cohort was planned to test an IW-3300 dose of ≤ 2500 μg. Based on a blinded review of safety and tolerability data from Cohort 1 through 4, the Dose Escalation Committee decided not to enroll the optional 5th Cohort.

Participant flow — Overall Study
Milestone	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300
Started	8	6	6	6	6
Completed	8	6	6	6	6
Not completed	0	0	0	0	0

Outcome measures

PrimaryNumber 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.

Time frame:: From first dose of study drug through 24 hours post-Day 1 dose
Reported as:: Count of participants · Participants

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Participants	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	2	1	0	1	2

PrimaryNumber 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.

Time frame:: From first dose of study drug through 24 hours post-Day 1 dose
Reported as:: Count of participants · Participants

Number of Participants With Serious TEAEs
Participants	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300
Number of Participants With Serious TEAEs	0	0	0	0	0

Adverse events

Collected over From first dose of study drug through 24 hours post-Day 1 dose. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/8 (0%)	0/8 (0%)	2/8 (25%)
100 μg IW-3300	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
300 μg IW-3300	0/6 (0%)	0/6 (0%)	0/6 (0%)
900 μg IW-3300	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
2500 μg IW-3300	0/6 (0%)	0/6 (0%)	2/6 (33.3%)

Most frequent other events

Most frequent other events
Event	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300
DiarrhoeaGastrointestinal disorders	0/8	1/6	0/6	0/6	1/6
Infrequent bowel movementsGastrointestinal disorders	1/8	0/6	0/6	1/6	0/6
MyalgiaMusculoskeletal and connective tissue disorders	0/8	0/6	0/6	0/6	1/6
Anorectal discomfortGastrointestinal disorders	1/8	0/6	0/6	0/6	0/6
HaematuriaRenal and urinary disorders	1/8	0/6	0/6	0/6	0/6

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300	Total
Mean	38.1 ± 12.64	29.8 ± 13.04	48.2 ± 11.30	39.7 ± 13.62	43.3 ± 13.76	39.7 ± 13.44

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300	Total
Female	1	1	2	1	2	7
Male	7	5	4	5	4	25

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300	Total
Hispanic or Latino	3	2	2	3	3	13
Not Hispanic or Latino	5	4	4	3	3	19
Unknown or Not Reported	0	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Placebo	100 μg IW-3300	300 μg IW-3300	900 μg IW-3300	2500 μg IW-3300	Total
White	5	4	6	4	4	23
Black or African American	3	2	0	1	1	7
Asian	0	0	0	1	0	1
Other, Not Specified	0	0	0	0	1	1

Study locations

1 site

PPD
Austin, Texas 78744, United States

References and documents

Study documents

Study protocol · Jan 10, 2022
Statistical analysis plan · Apr 6, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05188261
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Responsible party: Sponsor
First posted: Jan 12, 2022
Start date: Jan 18, 2022
Primary completion: Mar 9, 2022
Completion: Mar 21, 2022
Results posted: Dec 8, 2023
Last update: Dec 8, 2023

Study contacts

Ironwood Study Chair

study director · Ironwood Pharmaceuticals

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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