A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects

NCT05362695 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C3300-102
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is designed as a multiple-ascending-dose, safety and tolerability study with IW-3300. The study drug will be administered as a low-volume \[20 mL\] enema. Study participants will be randomized in a 2:1 ratio to receive IW-3300 or placebo. Up to 3 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)

• Incidence of 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 lifethreatening; 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 (6)

Cohort 1: 100 μg IW-3300

EXPERIMENTAL

100 μg dose of active drug (IW-3300) once daily for 7 days

Drug: IW-3300

Cohort 1: Placebo

PLACEBO COMPARATOR

matching placebo once daily for 7 days

Drug: Placebo

Cohort 2: 300 μg IW-3300

EXPERIMENTAL

300 μg dose of active drug (IW-3300) once daily for 7 days

Drug: IW-3300

Cohort 2: Placebo

PLACEBO COMPARATOR

matching placebo once daily for 7 days

Drug: Placebo

Cohort 3 (optional): Dose 3

EXPERIMENTAL

Active drug (IW-3300) once daily for 7 days

Drug: IW-3300

Cohort 3 (optional): Placebo

PLACEBO COMPARATOR

Matching placebo once daily for 7 days

Drug: Placebo

Interventions

IW-3300 DRUG

A dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema).

Cohort 1: 100 μg IW-3300; Cohort 2: 300 μg IW-3300; Cohort 3 (optional): Dose 3

Placebo DRUG

A dose of placebo administered rectally (as a low-volume \[20 mL\] enema).

Cohort 1: Placebo; Cohort 2: Placebo; Cohort 3 (optional): 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.
• Body mass index (BMI) within the range 18.5 to 35.0 kg/m\^2 (inclusive) at the Screening Visit.
• Male subjects and female partners are willing to use double-barrier method of contraception during the study.

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.
• Abnormal laboratory tests or clinically significant findings on safety tests conducted at the Screening Visit or at 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.

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: May 2, 2022
• First Posted: May 5, 2022
• Study Start: May 17, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 13, 2022
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)