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

NCT05362695 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-02

Study results available
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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

Interventions

DRUG

IW-3300

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Ironwood Study Chair · Ironwood Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-17
Primary Completion
2022-06-30
Completion
2022-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05362695 on ClinicalTrials.gov