A Phase 1 Placebo-controlled Study of the Safety and Tolerability of Rectally Administered, Multiple-ascending Doses of IW-3300 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort 3 (optional): Placebo
Matching placebo once daily for 7 days
干预措施: Placebo (Drug)
Cohort 1: 100 μg IW-3300
100 μg dose of active drug (IW-3300) once daily for 7 days
干预措施: IW-3300 (Drug)
Cohort 1: Placebo
matching placebo once daily for 7 days
干预措施: Placebo (Drug)
Cohort 2: 300 μg IW-3300
300 μg dose of active drug (IW-3300) once daily for 7 days
干预措施: IW-3300 (Drug)
Cohort 2: Placebo
matching placebo once daily for 7 days
干预措施: Placebo (Drug)
Cohort 3 (optional): Dose 3
Active drug (IW-3300) once daily for 7 days
干预措施: IW-3300 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: From first dose of study drug through 24 hours post-Day 1 dose
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and within 1 day of the last dose of study drug.
Number of Participants With Serious TEAEs
时间窗: From first dose of study drug through 24 hours post-Day 1 dose
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is lifethreatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; or other situations such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. An SAE was considered a treatment-emergent SAE (serious TEAE) if the SAE started after initial study drug administration and within 1 day of the last dose of study drug.
次要结局
未报告次要终点