Clinical trial NCT05362695: A Study of Multiple-ascending Doses of IW-3300 in Healthy Subjects
Official title: A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered, Multiple-ascending Doses of IW-3300 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: healthy volunteers
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.

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 adult participants. This study will assess the effect of IW-3300 on safety and tolerability.

The study includes up to 4 treatments: placebo and up to 3 dose levels of IW-3300 which will be determined after safety reviews of previous cohorts.

The 9 participants within each cohort will be randomized to receive IW-3300 (6 subjects) or placebo (3 participants), administered rectally (as a low-volume \[20 mL\] enema). Participants in each dosing cohort will progress through 3 study periods: (1) Screening Period, (2) Clinic Period, and (3) Follow-up Period. Treatment duration will be 7 days; participants will be followed in the Phase 1 clinical research unit (CRU) for the duration of dosing, until at least 24 hours after the last dose of study drug and contacted by phone for follow-up approximately 2 weeks after the last dose. Total participant participation will be 29 to 57 days, including the Screening, Clinic, and Follow-up Periods.

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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug through 24 hours post-Day 1 dose
measure: Number of Participants With Serious TEAEs
timeFrame: From first dose of study drug through 24 hours post-Day 1 dose
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
affiliation: Ironwood Pharmaceuticals
name: Ironwood Study Chair
role: STUDY_DIRECTOR
References: