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

NCT ID: NCT05362695

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-17
• Study Completion Date: 2022-07-13

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.

Detailed Description

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, multiple-ascending-dose study of IW-3300 administered rectally, once-daily, for 7 days as a low-volume enema in healthy adult participants. This study will assess the effect of IW-3300 on safety and tolerability.

The study includes up to 4 treatments: placebo and up to 3 dose levels of IW-3300 which will be determined after safety reviews of previous cohorts.

The 9 participants within each cohort will be randomized to receive IW-3300 (6 subjects) or placebo (3 participants), administered rectally (as a low-volume [20 mL] enema). Participants in each dosing cohort will progress through 3 study periods: (1) Screening Period, (2) Clinic Period, and (3) Follow-up Period. Treatment duration will be 7 days; participants will be followed in the Phase 1 clinical research unit (CRU) for the duration of dosing, until at least 24 hours after the last dose of study drug and contacted by phone for follow-up approximately 2 weeks after the last dose. Total participant participation will be 29 to 57 days, including the Screening, Clinic, and Follow-up Periods.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cohort 1: 100 μg IW-3300

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

Group Type: EXPERIMENTAL

IW-3300

Intervention Type: DRUG

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

Cohort 1: Placebo

matching placebo once daily for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Cohort 2: 300 μg IW-3300

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

Group Type: EXPERIMENTAL

IW-3300

Intervention Type: DRUG

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

Cohort 2: Placebo

matching placebo once daily for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Cohort 3 (optional): Dose 3

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

Group Type: EXPERIMENTAL

IW-3300

Intervention Type: DRUG

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

Cohort 3 (optional): Placebo

Matching placebo once daily for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

IW-3300

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.
• 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.

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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ironwood Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ironwood Study Chair

Role: STUDY_DIRECTOR

Ironwood Pharmaceuticals

Locations

PPD

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

C3300-102

Identifier Type: -

Identifier Source: org_study_id