A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously As Single Ascending Doses to Healthy Participants
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, severity and relationship to study treatment of Adverse Events(AEs)
研究概览
简要总结
This is a Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously as Single Ascending Doses to Healthy Participants. Male or female subjects aged 18 to 50 years (inclusive) who fulfill the inclusion/exclusion criteria will be enrolled in this study.
详细描述
ILB-202 is an engineered exosome loaded with super-repressor IκBα. This is Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study.
Healthy volunteers, 18-55 years of age, selected from healthy participants fulfilling the inclusion/exclusion criteria.
18 subjects will participate in the study. Doses of investigational product (IP) will be administered intravenously on Day 1. During the Screening Period (within the 28 days) each subject will be assessed for eligibility. Each subject must sign and date an informed consent form (ICF) prior to undergoing any study-related procedures.
All dosed subject samples will be analyzed and their data will be included in the final study report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have given written informed consent and must be able to understand the full nature and purpose of the trial.
- •Aged 18 to 55 years of age (inclusive).
- •A body mass index (BMI) of ≥ 18.0 and ≤ 30.0 kg/m2 .
- •Medically healthy male or female volunteers, without clinically significant abnormalities.
- •Conventional 12-lead ECG recording in triplicate consistent with normal cardiac conduction and function.
- •Must be of non-child-bearing potential, or must be on a suitable birth control method.
排除标准
- •History or evidence of any clinically significant condition and/or other major disease or malignancy.
- •History of drug allergies and drug or alcohol abuse .
- •Clinically significant abnormalities in the physical examination, vital signs, ECG or clinical laboratory tests.
- •Exposure to any prescription medications or, administered over the counter drugs, dietary supplements, or herbal remedies, within 14 days or 5 half-lives, prior to dosing.
- •Received treatment with immune-suppressive or immune-modulative medication within 90 days prior to dosing.
- •Exposure to biologics within 6 months prior to dosing.
- •Participation in another clinical trial within 30 days (or 6 months for biologics) prior to dosing.
研究组 & 干预措施
ILB-202
ILB-202 exosome with Clinical grade normal saline (0.9% sodium chloride for intravenous injection)
干预措施: ILB-202 (Drug)
Placebo
Clinical grade normal saline (0.9% sodium chloride for intravenous injection)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, severity and relationship to study treatment of Adverse Events(AEs)
时间窗: Day 1 (administration) through Day 8
Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events(CTCAE) v5.0
Concomitant medication usage
时间窗: Day 1 (administration) through Day 8
Number of participants with new(additional) treatment
Specific Parameter Change from Baseline to End of Study
时间窗: Day 1 (administration) through Day 8
Number of participants with clinically significant changes in * body weight * vital signs * Electrocardiogram(ECG) parameters * clinical laboratory parameters
次要结局
未报告次要终点