NCT07024160招募中1 期
A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose (SAD) Administration of MT1011 Injection in Healthy Subjects
Shaanxi Micot Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月25日最近更新:
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
- 40
- 试验地点
- 1
- 主要终点
- Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).
研究概览
简要总结
This is a single-center, randomized,double-blind, placebo-controlled Phase I study to evaluate safety, PK and PD of single ascending dose (SAD) of MT1011 injection in healthy adult subjects. Includes 5 dose cohorts, with 40 subjects planned for enrollment.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects (with at least 1/4 being either female or male), aged 18 to 45 years (inclusive) at screening;
- •Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening, with a Body Mass Index [BMI = weight (kg) / height² (m²)] within the range of 18.5 to 26.0 kg/m² (inclusive);
- •Subjects must provide informed consent for this study prior to participation and voluntarily sign a written informed consent form;
- •Subjects must be able to maintain good communication with the investigators.
排除标准
- •Subjects with abnormal and clinically significant findings in vital signs, physical examination, laboratory tests (blood routine, urinalysis, blood biochemistry, coagulation function), abdominal ultrasound, or chest X-ray as determined by the investigator;
- •Women who are pregnant or breastfeeding, or female subjects with positive pregnancy tests; Subjects (or their partners) planning pregnancy, or planning to donate sperm/ova during the study or within
研究组 & 干预措施
MT1011
Experimental
Interventional: The SAD study involves single administration of MT1011
干预措施: MT1011 (Drug)
Placebo
Placebo Comparator
Placebo: The SAD study involves single administration of Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of AEs (Adverse Events) and SAEs (Serious Adverse Events)and treatment-related adverse events (TEAEs).
时间窗: up to Day 14
The occurrence of all adverse events (AEs), serious adverse events (SAEs)
次要结局
- International normalized ratios(Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.)
- Cmax of MT1011(Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.)
- Tmax of MT1011(Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.)
- T1/2 of MT1011(Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.)
- AUC0-tau of MT1011(Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.)
- AUC0-t of MT1011(Within 1 hour before dosing on Day 1 (D1), and at 5min,15min,0.5,1, 2, 4, 8, 12, 24, 48 hours post-dose.)
- Whole blood clotting time(Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.)
- Activated partial thromboplastin time(Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.)
- Prothrombin time(Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.)
- fibrinogen(Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.)
- Thrombin time(Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.)
- Factor Xa activity(Within 1 hour before dosing on Day 1 (D1), and at 15min, 2, 24 hours post-dose.)
研究者
研究点 (1)
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