NCT05362695

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

A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered, Multiple-ascending Doses of IW-3300 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-05-17
• Primary completion: 2022-06-30
• Completion: 2022-07-13
• First posted: 2022-05-05
• Last updated: 2024-02-02
• Results posted: 2024-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study