NCT07172646招募中1 期
A Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose-Escalation and -Expansion Study to Evaluate the Safety, Tolerability, PK, and PD of Subcutaneously Administered SRSD216 in Patients With Elevated Lipoprotein(a)
Sirius Therapeutics Co., Ltd.1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年4月7日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 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 is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with elevated Lp(a) level with or without ASCVD history.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;
- •Males or females, of any race;
- •Body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive;
- •Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.
排除标准
- •Any history or evidence of abnormal bleeding or coagulopathy; or evidence of prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombosis; or history of spontaneous bleeding;
- •Evidence of active or suspected cancer within 3 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 years is allowed);
- •Acute febrile illness within 7 days prior to dose administration or evidence of active infection;
- •Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;
- •History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;
- •Fasting TG≥ 500 mg/dL (5.6 mmol/L) during screening;
- •Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study;
- •Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.
研究组 & 干预措施
0.9% Sodium Chloride (Part 2)
Placebo Comparator
Placbo administered SC. in subjects of Part 2
干预措施: SRSD216 injection (Drug)
0.9% Sodium Chloride (Part 2)
Placebo Comparator
Placbo administered SC. in subjects of Part 2
干预措施: Placebo (Drug)
SRSD216 injection (Part 1)
Experimental
SRSD216 administered SC. in subjects of Part 1
干预措施: SRSD216 injection (Drug)
SRSD216 injection (Part 2)
Experimental
SRSD216 administered SC. in subjects of Part 2
干预措施: SRSD216 injection (Drug)
SRSD216 injection (Part 2)
Experimental
SRSD216 administered SC. in subjects of Part 2
干预措施: Placebo (Drug)
0.9% Sodium Chloride (Part 1)
Experimental
Placbo administered SC. in subjects of Part 1
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: 1 year
A summary of TEAE to evaluate the safety and tolerability of SRSD216
次要结局
未报告次要终点
研究者
研究点 (1)
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