Status:
COMPLETED
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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 b...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05362695
Start Date
May 17 2022
End Date
July 13 2022
Last Update
February 2 2024
Active Locations (1)
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1
PPD
Austin, Texas, United States, 78744