NCT06452771进行中（未招募）1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of ALN-ANG3 in Otherwise Healthy Adult Participants
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 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 study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants with an elevated level of blood lipids (eg, cholesterol and triglycerides).
The aim of the study is to see how safe and tolerable the study drug is in healthy adult participants.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
详细描述
This is a 2-Part study. Participants in Part A are excluded from participation in Part B
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram's (ECG's) performed at screening and/or prior to administration of initial dose of study drug
- •Has fasting triglyceride (TG) levels >=100 and <500 mg/dL (1.13-5.65 mmol/L), defined as hyperlipidemia, and fasting Low-Density Lipoprotein (LDL-C) >=70 and <=300 mg/dL (1.81-7.76 mmol/L), defined as hyperlipidemia, during screening visit. Testing may be repeated once during the screening period in case the visit 1 levels fall outside of the required range
- •Has a body mass index between 18 and 35 kg/m^2, inclusive, at screening visit
排除标准
- •History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological or other disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
- •Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
- •Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
- •Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
- •With the exception of stable (approximately 3 months at same dose level) statin use, any prescription medication for approximately 2 weeks or 5 half-lives, whichever is longer, prior to first administration of the study drug through the End Of Study (EOS). Non-prescription medications and nutritional supplements are permitted after alignment of investigator and sponsor on their use
- •Using the Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology (CKD-EPI) equation, has an estimated Glomerular Filtration Rate (GFR) of <60 mL/min/1.73m2 at the screening visit, as defined in the protocol
- •Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) with clinically significant abnormality in the opinion of investigator or ≥1.5× Upper Limit of Normal (ULN) range at screening or day -1 visits
- •Is positive for Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen (HBsAg) at the screening visit. Evidence of prior hepatitis B immunization or prior resolved hepatitis B infection is not an exclusion
- •Is positive for hepatitis C antibody and positive for qualitative (ie, detected or not detected) Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) test at the screening visit
- •NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
研究组 & 干预措施
Part B: Cohorts
Experimental
干预措施: Placebo (PB) (Drug)
Part A: Cohorts
Experimental
干预措施: ALN-ANG3 (Drug)
Part A: Cohorts
Experimental
干预措施: Placebo (PB) (Drug)
Part B: Cohorts
Experimental
干预措施: ALN-ANG3 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Approximately 323 Days
In participants treated with ALN-ANG3 or placebo (PBO)
Severity of TEAEs
时间窗: Up to Approximately 323 Days
In participants treated with ALN-ANG3 or PBO
次要结局
- Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma(Prior to Each Dose up to Approximately 323 Days)
- Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma(Within 3 Days Post Dose up to Approximately 323 Days)
研究者
研究点 (1)
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