A Study of Single Ascending Doses of IW-3300 in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: IW-3300; Placebo
Intervention description: A single dose of IW-3300 administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours.; A single dose of placebo administered rectally (as a low-volume [20 mL] enema) following a fast of at least 6 hours.
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: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy volunteers

Summary:

      This is a first-in-human study to evaluate the safety and tolerability of single ascending
      doses of IW-3300. The study drug will be administered rectally as a low-volume (20 mL) enema.
      Study participants will be randomized in a 3:1 ratio to receive a single dose of IW-3300 or
      placebo. Up to 5 different doses of IW-3300 will be studied. Safety reviews will be conducted
      before proceeding to each higher dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and female subjects of non-childbearing potential

          2. Ages 18 to 60 years

          3. Medically healthy with no clinically significant findings during medical evaluation
             including physical examination, 12-lead electrocardiogram (ECG), and clinical
             laboratory tests.

          4. Normal bowel movement frequency of formed stool at baseline (≥3 per week and ≤3 per
             day; average Bristol stool form scale (BSFS) score of >2 and <6).

          5. Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 (inclusive) at the Screening
             Visit.

          6. Male subjects and female partners are willing to use double-barrier method of
             contraception during the study.

          7. If subject is ≥45 years of age, subject is compliant with colorectal cancer screening
             guidelines according to the American College of Gastroenterology (ACG) Clinical
             Guidelines: Colorectal Cancer Screening 2021.

        Exclusion Criteria:

          1. Evidence or history of clinically significant acute or chronic disease, or clinically
             significant illness within 30 days of the Screening Visit.

          2. History of clinically significant hypersensitivity or allergies to any of the inactive
             ingredients contained in the active or placebo drug products.

          3. History of any condition that would interfere with their ability to receive an enema,
             or has had difficulty receiving an enema in the past.

          4. Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or
             history of inflammatory bowel disease.

          5. Used a prescription medication during the 14 days before Check-in

          6. Used any over-the-counter medications, including laxatives, and herbal supplements
             during the 7 days before Check-in.

          7. Received a licensed or investigational vaccine during the 30 days before Check-in or
             is planning to receive any vaccine during the study.

          8. Recently received or donated blood products.

          9. Undergone a surgical procedure during the 30 days before Check-in, other than minor
             dermatologic procedures, or has a history of surgery involving the GI tract or anal
             canal (with the exception of endoscopic procedures, appendectomy, and
             cholecystectomy).

         10. Received any investigational drug during the 30 days or 5 half-lives of that
             investigational drug (whichever is longer) before the Screening Visit, or is planning
             to receive another investigational drug at any time during the study.

         11. Abnormal laboratory tests or clinically significant findings on safety tests conducted
             at the Screening Visit or at Check-in.

         12. Confirmed or suspected infection with COVID-19 at the Screening Visit or Check-in.

         13. 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.

         14. History of alcohol or drug addiction during the year before the Screening Visit, or
             has a positive drug or alcohol screen at the Screening Visit or Check-in.