A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
Condition: Healthy Volunteers
Intervention: IW-3300; Placebo
Intervention description: 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).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The investigator and all other clinical research unit staff, sponsor study personnel, and the participant will remain blinded to individual participant treatment assignments throughout the study. Treatment assignments of individual participants will only be unblinded to a sponsor representative for regulatory reporting purposes or if warranted by emerging safety or tolerability issues.
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy volunteers

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.
    

Eligibility criteria:

        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.