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

C3300-102

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.

2022-05-17

2022-06-30

2022-07-13

Completed

Early phase I

18

Inclusion Criteria: * 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 Criteria: * 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.

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2024-02-02