NCT06760455招募中1 期
A Single-center, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Study to Evaluate the Safety and Tolerability of BPR-30221616 Injection in Healthy Subjects
Chengdu Brilliant Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年1月10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
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of Participants With Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, pharmacokinetics、 pharmacodynamics and immunogenicity of BPR-30221616 in 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
- Double (Participant, Investigator)
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
- •Male and female healthy subjects.
- •Age 18 to 65 years.
- •Male weight ≥ 50.0 kg ，female weight ≥ 45.0 kg ， BMI ≥18.0 and ≤30.0 kg/m^
- •Females must be non-pregnant and non-lactating.
- •Subjects must give informed consent prior to the trial and willing to give written informed consent form.
- •Subjects who can communicate reliably with the investigator and comply with all study requirements .
排除标准
- •Subjects who have a clinically relevant history or presence of neurological,respiratory, gastrointestinal, cardiovascular, haematological, immunological, genitourinary,hepatic,renal, musculoskeletal diseases， or considered unfit for the study by the investigator with new disease within the 7 days prior to dose administration.
- •Subjects with a history of serious mental illness.
- •Clinically-significant (CS) abnormalities in physical examination, vital signs, electrocardiogram, clinical laboratory examination , chest radiograph and abdominal ultrasound at screening visit.
- •Alanine aminotransferase (ALT) >1.5× normal upper limit (ULN), or aspartate aminotransferase (AST) >1.5×ULN, or total bilirubin >1.5×ULN at screening visit.
- •Glomerular filtration rate (eGFR) <90mL/min/1.73m2 at screening visit.
- •Vitamin A level < lower limit of normal (LLN) at screening visit.
- •Uncontrolled ventricular arrhythmias, or co-morbidities that may cause prolonged QT.
- •Known history of allergic reactions to 2 or more drugs or to N-acetylated galactosamine (GalNAc) or oligonucleotides.
- •Subjects who had undergone major surgery within 6 months prior to screening or planned to undergo surgery during the study period, and who had previously undergone surgery that would affect drug absorption, distribution, metabolism, or excretion (except surgery for appendicitis).
- •Alcoholic or regular drinking within the 6 months of randomization; Or a positive baseline alcohol breath test.
- •Subjects who have a history of drug abuse within the 12 months of screening or have a positive baseline drug screening result.
- •Smoking >5 cigarettes a day.
- •Known human immunodeficiency virus (HIV) ,Treponema pallidum Antibody (TP-Ab),hepatitis B surface antigen (HBsAg)or hepatitis C virus (HCV) infection at screening visit.
- •Subjects who have donated 400 mL or more of blood within the 3 months prior to dose administration or plan to donate until 6 months after dose administration.
- •From the signing of informed consent, throughout the study until 12 months after dose administration , unwilling to use appropriate and effective contraceptions.
- •Received an investigational agent or device intervention within 3 months of screening.
- •Received prescription drugs within 4 weeks of randomization.
- •Received over-the-counter drugs(unless deemed not clinically relevant by the investigator) within 7 days of randomization.
- •Received any oligonucleotides[including small interfering ribonucleic acid(siRNA) and antisense oligonucleotides].
- •Intolerance to subcutaneous injection.
- •Had a special diet (such as grapefruit and products containing grapefruit, chocolate, any food containing caffeine or rich in xanthines (such as animal liver)) or had strenuous activity within 48 hours prior to dose administration , or with other factors affecting drug absorption, distribution, metabolism, excretion.
- •Any physical or mental illness or condition that, as determined by the study physician, is likely to increase the risk of the study, interfere with the subject's adherence to the protocol, or interfere with the subject's completion of the study.
研究组 & 干预措施
BPR-30221616 Injection
Experimental
干预措施: BPR-30221616 Injection (Drug)
Sodium Chloride Injection
Placebo Comparator
干预措施: Sodium Chloride Injection (Drug)
结局指标
主要结局
Incidence of Participants With Adverse Events (AE)
时间窗: Up to Day 360
Incidence of Participants With Serious Adverse Events (SAE)
时间窗: Up to Day 360
Incidence of Participants With Clinically Significant laboratory tests, electrocardiogram (ECG), physical examination, vital signs
时间窗: Up to Day 360
次要结局
- Maximum plasma concentration （Cmax）of BPR-30221616(Day 1 through to Day 3)
- Time to maximum plasma concentration（Tmax） of BPR-30221616(Day 1 through to Day 3)
- Area under the plasma concentration-time curve（AUC）of BPR-30221616(Day 1 through to Day 3)
- Elimination rate constant (λz) of BPR-30221616(Day 1 through to Day 3)
- Elimination half-life (t1/2) of BPR-30221616(Day 1 through to Day 3)
- Apparent volume of distribution during terminal phase (Vz/F) of BPR-30221616(Day 1 through to Day 3)
- Clearance (CL/F) of BPR-30221616(Day 1 through to Day 3)
- Mean residence time from zero to infinity (MRT0-∞) of BPR-30221616(Day 1 through to Day 3)
- Cumulative amount of the dose excreted unchanged in urine (Ae) of BPR-30221616(Day 1 through to Day 3)
- Cumulative fraction of the dose excreted unchanged in urine (Fe) of BPR-30221616(Day 1 through to Day 3)
- Renal clearance(CLr) of BPR-30221616(Day 1 through to Day 3)
- Effect of BPR-30221616 on serum transthyretin（TTR） levels as measured by reduction from baseline in serum TTR(Day 1 through to Day 540)
- Number of participants who develop serum anti-BPR-30221616 antibodies(Day 1 through to Day 360)
研究者
研究点 (1)
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