NCT06700083已完成1 期
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Subcutaneous Injections of SHR-6934 in Healthy Subjects: a Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Trial
Beijing Suncadia Pharmaceuticals Co., Ltd1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年1月6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
- 72
- 试验地点
- 1
- 主要终点
- Incidence of subjects with adverse events (AEs)
研究概览
简要总结
This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
- •Male or female aged 18-60;
- •Females must have a negative pregnancy test at the Screening Visit;
- •Body mass index (BMI) between 19 and 28 kg/m2;
- •Normal Electrocardiogram (ECG);
- •Men and women of childbearing potential must agree to take effective contraceptive methods.
排除标准
- •History of any clinically important disease or disorder;
- •History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug;
- •Prior history of risk factors for Torsades de Pointes, such as unexplained syncope, definite long QT syndrome (including family history), heart failure, myocardial infarction, angina pectoris;
- •Systolic blood pressure (SBP)≥140 mmHg or <90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or <60 mmHg;
- •Patients with orthostatic hypotension;
- •Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
研究组 & 干预措施
MAD dose 1
Experimental
干预措施: SHR-6934 placebo (Drug)
MAD dose 3
Experimental
干预措施: SHR-6934 injection (Drug)
MAD dose 2
Experimental
干预措施: SHR-6934 injection (Drug)
MAD dose 2
Experimental
干预措施: SHR-6934 placebo (Drug)
MAD dose 4
Experimental
干预措施: SHR-6934 injection (Drug)
MAD dose 4
Experimental
干预措施: SHR-6934 placebo (Drug)
SAD dose 6
Experimental
干预措施: SHR-6934 placebo (Drug)
SAD dose 1
Experimental
干预措施: SHR-6934 injection (Drug)
SAD dose 1
Experimental
干预措施: SHR-6934 placebo (Drug)
SAD dose 2
Experimental
干预措施: SHR-6934 placebo (Drug)
SAD dose 2
Experimental
干预措施: SHR-6934 injection (Drug)
SAD dose 4
Experimental
干预措施: SHR-6934 placebo (Drug)
SAD dose 6
Experimental
干预措施: SHR-6934 injection (Drug)
MAD dose 3
Experimental
干预措施: SHR-6934 placebo (Drug)
SAD dose 3
Experimental
干预措施: SHR-6934 injection (Drug)
SAD dose 3
Experimental
干预措施: SHR-6934 placebo (Drug)
SAD dose 4
Experimental
干预措施: SHR-6934 injection (Drug)
SAD dose 5
Experimental
干预措施: SHR-6934 injection (Drug)
SAD dose 5
Experimental
干预措施: SHR-6934 placebo (Drug)
MAD dose 1
Experimental
干预措施: SHR-6934 injection (Drug)
结局指标
主要结局
Incidence of subjects with adverse events (AEs)
时间窗: Baseline up to 113 days after the last dosing
次要结局
- Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for SHR-6934(Baseline up to 113 days after the last dosing)
- Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for SHR-6934(Baseline up to 113 days after the last dosing)
- Maximum plasma concentration (Cmax) for SHR-6934(Baseline up to 113 days after the last dosing)
- Time to reach maximum plasma concentration (Tmax) for SHR-6934(Baseline up to 113 days after the last dosing)
- Terminal half-life (t1/2) for SHR-6934(Baseline up to 113 days after the last dosing)
- Apparent clearance (CL/F) of SHR-6934 for administration subcutaneously(Baseline up to 113 days after the last dosing)
- Apparent volume of distribution (V/F) of SHR-6934 for administration subcutaneously(Baseline up to 113 days after the last dosing)
- Proportion of anti-drug antibodies (ADA) positive subjects(Baseline up to 113 days after the last dosing)
- Baseline and placebo-adjusted QTcF after SHR-6934(Baseline up to 15 days after dosing)
研究者
研究点 (1)
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