NCT05188261

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

A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered Single Ascending Doses of IW-3300 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ironwood Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single-ascending-dose study assessing the safety, tolerability, and pharmacokinetics (PK) of IW 3300 administered rectally as a low-volume enema in healthy adult volunteers. This first-in-human study will assess participants for safety, tolerability, and PK. The study includes up to 6 treatments: placebo and up to 5 dose levels of IW-3300 which will be determined after safety reviews of previous cohorts. This study will enroll a maximum of 40 participants (up to 5 cohorts of 8 participants each). The 8 participants within each cohort will be randomized in a double-blind manner to receive a single dose of IW-3300 (6 participants) or placebo (2 participants), administered rectally as a low-volume \[20 mL\] enema. Each cohort will progress through a Screening Period, Clinic Period, and Follow-up Period. Treatment duration will be 1 day. Participants will remain in the Phase 1 unit for approximately 24 hours after dosing and will be contacted by phone for follow-up approximately 2 weeks after dosing. Total participation will be 22 to 45 days, including the Screening, Clinic, and Follow-up Periods.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	IW-3300	A single dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.
DRUG	Placebo	A single dose of placebo administered rectally (as a low-volume \[20 mL\] enema) following a fast of at least 6 hours.

Timeline

• Start date: 2022-01-18
• Primary completion: 2022-03-09
• Completion: 2022-03-21
• First posted: 2022-01-12
• Last updated: 2023-12-08
• Results posted: 2023-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study