A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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.
Key facts
- Study ID
- NCT05362695
- Run by
- Ironwood Pharmaceuticals, Inc.
- People needed
- 18
- Starts
- 2022-05-17
- Expected to finish
- 2022-07-13
- Last updated by the study team
- 2024-02-02
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- PPD — Austin, Texas, United States
Full record on ClinicalTrials.gov
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