Phase 1
Completed N=18
A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
Healthy Volunteers
Source: ClinicalTrials.gov NCT05362695 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Incidence of Treatment-Emergent Adverse Events (TEAEs) — 3; 3; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-Emergent Adverse Events (TEAEs) |
3; 3; 2 | — |
| PRIMARY Number of Participants With Serious TEAEs |
0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT05362695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.