A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration
研究概览
简要总结
This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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 (sex at birth).
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index 18.5-29.9 kilograms per square metre (kg/m^2) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1).
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.
排除标准
- •Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.
- •Alanine aminotransferase (ALT) greater than (>) upper limit of normal (ULN) +10 percentage (%)
- •Aspartate aminotransferase (AST) >ULN +20%
- •Bilirubin >ULN +20%
- •Creatinine >ULN +10%
- •Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI]) less than (<) 90 milliliters per minute/1.73square meter (mL/min/1.73m^2)
- •Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 30 milligrams per gram (mg/g)
- •Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).
- •Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.
- •Heart rate outside the range of 50-89 beats/minute at screening (visit 1).
- •Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.
- •Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin <90 grams per litre (g/L))
- •Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.
- •Presence of thrombocytopenia, defined as thrombocyte count <150 x 10^9 cells/L at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder.
- •Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).
研究组 & 干预措施
Sequence B
Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously.
干预措施: CDR132L (s.c.) (Drug)
Sequence B
Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously.
干预措施: CDR132L (i.v.) (Drug)
Sequence A
Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously.
干预措施: CDR132L (s.c.) (Drug)
Sequence C
Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously.
干预措施: CDR132L (i.v.) (Drug)
Sequence C
Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously.
干预措施: CDR132L (s.c.) (Drug)
Sequence D
Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously.
干预措施: CDR132L (i.v.) (Drug)
Sequence D
Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously.
干预措施: CDR132L (s.c.) (Drug)
Sequence A
Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously.
干预措施: CDR132L (i.v.) (Drug)
结局指标
主要结局
Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration
时间窗: From 0 to 840 hours after CDR132L administration
Measured as hours\*nanograms per milliliter (h\*ng/mL)
次要结局
- Terminal half-life for CDR132L after a single dose(From 0 to 840 hours after CDR132L administration)
- Total plasma clearance of CDR132L after a single dose(From 0 to 840 hours after CDR132L administration)
- Time to maximum observed CDR132L plasma concentration after a single dose(From 0 to 840 hours after CDR132L administration)
- Area under the CDR132L plasma concentration-time curve from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration, divided by dose(From 0 to 840 hours after CDR132L administration)
- Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values(From 0 to 840 hours after CDR132L administration)
- Mean residence time for CDR132L after a single dose(From 0 to 840 hours after CDR132L administration)
- Number of adverse events(From first CDR132L administration (day 1) to day 141)