A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of RGLS8429
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
Primary Objective
• To assess the safety and tolerability of single ascending doses of RGLS8429
Secondary Objectives
- To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429
- To characterize the pharmacokinetic (PK) properties of RGLS8429
详细描述
In this randomized, double-blind, placebo-controlled Phase 1 study, a single ascending dose of RGLS8429 or placebo will be administered via subcutaneous (SC) injection to healthy volunteers to evaluate the safety, tolerability, and PK of RGLS8429.
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
- Double (Participant, Investigator)
盲法说明
This will be a double-blinded, randomized, placebo-controlled study.
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
- •Male or female, 18 to 55 years of age
- •Body mass index (BMI) 18 to 35 kg/m2
- •Medically healthy, with no clinically significant medical history in the opinion of the Investigator
- •Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2
- •Must understand and consent to the study procedures explained in the informed consent form (ICF) and be willing and able to comply with the protocol
排除标准
- •Subject is mentally incapacitated or has significant emotional problems
- •Any medical condition or social circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety
- •History or presence of alcoholism or drug abuse within the past 2 years prior to Screening
- •Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. The 28-day and 5-half-life windows will be calculated from the date of the last dosing in the previous study to Day 1 of the current study.
研究组 & 干预措施
RGLS8429, first dose level
Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo
干预措施: RGLS8429 (Drug)
RGLS8429, first dose level
Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo
干预措施: Placebo volume-matching RGLS8429 dose (Drug)
RGLS8429, second dose level
Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo
干预措施: RGLS8429 (Drug)
RGLS8429, second dose level
Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo
干预措施: Placebo volume-matching RGLS8429 dose (Drug)
RGLS8429, third dose level
Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo
干预措施: RGLS8429 (Drug)
RGLS8429, third dose level
Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo
干预措施: Placebo volume-matching RGLS8429 dose (Drug)
RGLS8429, fourth dose level
Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo
干预措施: RGLS8429 (Drug)
RGLS8429, fourth dose level
Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo
干预措施: Placebo volume-matching RGLS8429 dose (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Baseline to Day 29
Incidence and severity of adverse events after administration of RGLS8429
次要结局
- Incidence of DLT and Determination of MTD(Baseline to Day 29)
- Plasma Half-life (T1/2) of RGLS8429(Baseline to Day 15)
- Plasma Clearance of RGLS8429(Baseline to Day 15)
- Area Under the Plasma Concentration vs Time Curve (AUC) of RGLS8429(Baseline to Day 15)
- Amount of RGLS8429 Excreted in Urine(Baseline to 24-hour)