A Phase 1a, Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RN5681 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single doses of RN5681 in Adult healthy subjects
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 18 to 35 kg/m2
- •Fasting LDL-C ≥70 mg/dL (1.81 mmol/L) (all SAD cohorts); fasting LDL-C ≥100 mg/dL (2.59 mmol/L) (POC cohort only)
- •Lp(a) at Screening: SAD cohort: ≥25 nmol/L POC cohort: ≥100 nmol/L
- •Fasting triglycerides <400 mg/dL (4.51 mmol/L) at Screening
- •No clinically significant abnormalities of hepatic or renal function
排除标准
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5× the upper limit of normal at screening
- •Hemoglobin A1c (HbA1c) ≥6.5% at screening
- •Current regular smoker (defined as >2 cigarettes/day or >10 cigarettes/week) within 3 months prior to screening
- •Use of any siRNA, antisense oligonucleotide (ASO), cell and gene therapy, or clustered regularly interspaced short palindromic repeats (CRISPR) agent in the prior 12 months
- •Received any prescription lipid-lowering medication, including but not limited to statins, ezetimibe, and PCSK9 inhibitors to alter serum lipids within 30 days before screening
研究组 & 干预措施
Placebo
Drug: Placebo control 0.9% normal saline subcutaneous injection
干预措施: Placebo control (Drug)
RN5681
Drug: RN5681 Investigational product subcutaneous injections
干预措施: RN5681 (Drug)
结局指标
主要结局
in SAD cohort, To assess the safety and tolerability of subcutaneously (SC) administered RN5681
时间窗: From the enrollment to the end of treatment at Day180
Incidence, severity, and causal relationship of adverse events (AEs) as reported by the Investigator, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0
in POC cohort, To assess the metabolic markers of efficacy
时间窗: From enrollment to the end of treatment at Day 180
Percent change from Baseline in serum LDL-C and Lp(a) at Day 180
次要结局
未报告次要终点