At a glance
ClinicalIndex Comparison Record- ✓Ages 18 to 60 years
- ✓Medically healthy with no clinically significant findings on physical exam, ECG, and lab tests
- ✓BMI 18.5–35.0 kg/m²
- ✓Males and female subjects of non-childbearing potential
- ✕Acute or chronic disease, or clinically significant illness within 30 days of screening
- ✕History of conditions interfering with ability to receive an enema or difficulty receiving enema in the past
- ✕Recent history of anal fissure, anal abscess, complicated hemorrhoids, or inflammatory bowel disease
- ✕Hypersensitivity or allergies to inactive ingredients in the drug products
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered, Multiple-ascending Doses of IW-3300 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating IW-3300 and Placebo for Healthy Volunteers. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A dose of IW-3300 administered rectally (as a low-volume \[20 mL\] enema).
A dose of placebo administered rectally (as a low-volume \[20 mL\] enema).