NCT06613763已完成1 期
Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年9月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
研究概览
简要总结
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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 ≤28kg/m2 and total body weight >50 kg(male) or >40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- •Ability to understand and willingness to sign a written informed consent form;
- •Participants with normal renal function only:
- •Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant；
- •Glomerular filtration rate (GFR)≥ 90 mL/min and <130 mL/min ；
- •Age, BMI, and sex comparable to those of subjects of renal impairment；
- •Participants with severe renal impairment only:
- •Diagnosis of CKD (any indicators of renal impairment or GFR < 60 mL/min/1.73 m2 for more than 3 months)；
排除标准
- •Participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to RAY1225 or related compounds;
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- •Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months or donated blood or bleeding profusely (> 200 mL) in the 1 months;
- •Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- •Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- •Participants with severe renal impairment only:
- •Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
- •Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
- •New York heart association (NYHA) class III or IV congestive heart failure
- •Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin > 1.5×ULN;
研究组 & 干预措施
RAY1225 - Mild Renal Impairment
Experimental
RAY1225 3mg administered SC to participants with mild renal impairment.
干预措施: RAY1225 (Drug)
RAY1225 - Moderate Renal Impairment
Experimental
RAY1225 3mg administered SC to participants with moderate renal impairment.
干预措施: RAY1225 (Drug)
RAY1225 - Severe Renal Impairment
Experimental
RAY1225 3mg administered SC to participants with severe renal impairment.
干预措施: RAY1225 (Drug)
RAY1225 - Control
Experimental
RAY1225 3 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function.
干预措施: RAY1225 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
时间窗: Baseline through Day 43
PK: Maximum Concentration of RAY1225
时间窗: Baseline through Day 43
次要结局
- Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)(Baseline through Day 43)
研究者
研究点 (1)
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