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

NCT05188261 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C3300-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From first dose of study drug through 24 hours post-Day 1 dose

Study Arms (8)

Cohort 1: 100 μg IW-3300

EXPERIMENTAL

Dose 1: within the cohort, 6 participants receive active drug (IW-3300)

Drug: IW-3300

Cohort 1: Placebo

PLACEBO COMPARATOR

Within the cohort, 2 participants will receive the matching placebo dose

Drug: Placebo

Cohort 2: 300 μg IW-3300

EXPERIMENTAL

Dose 2: within the cohort, 6 participants receive active drug (IW-3300)

Drug: IW-3300

Cohort 2: Placebo

PLACEBO COMPARATOR

Within the cohort, 2 participants will receive the matching placebo dose

Drug: Placebo

Cohort 3: 900 μg IW-3300

EXPERIMENTAL

Dose 3: within the cohort, 6 participants receive active drug (IW-3300)

Drug: IW-3300

Cohort 3: Placebo

PLACEBO COMPARATOR

Within the cohort, 2 participants will receive the matching placebo dose

Drug: Placebo

Cohort 4: 2500 μg IW-3300

EXPERIMENTAL

Dose 4: within the cohort, 6 participants receive active drug (IW-3300)

Drug: IW-3300

Cohort 4: Placebo

PLACEBO COMPARATOR

Within the cohort, 2 participants will receive the matching placebo dose

Drug: Placebo

Interventions

IW-3300 DRUG

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: 100 μg IW-3300; Cohort 2: 300 μg IW-3300; Cohort 3: 900 μg IW-3300; Cohort 4: 2500 μg IW-3300

Placebo DRUG

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

Cohort 1: Placebo; Cohort 2: Placebo; Cohort 3: Placebo; Cohort 4: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead

Study Sites (1)

PPD

Austin, Texas, 78744, United States

Location

Results Point of Contact

• Title: Ironwood Study Chair
• Organization: Ironwood Pharmaceuticals, Inc

info@ironwoodpharma.com

617-621-7722

Study Officials

• Ironwood Study Chair

  Ironwood Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The investigator and all other clinical research unit staff, sponsor study personnel, and the participant will remain blinded to individual participant treatment assignments throughout the study. Treatment assignments of individual participants will only be unblinded to a sponsor representative for regulatory reporting purposes or if warranted by emerging safety or tolerability issues.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 12, 2022
• Study Start: January 18, 2022
• Primary Completion: March 9, 2022
• Study Completion: March 21, 2022
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)