NCT07032688招募中1 期
A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 Injection at Steady State in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss).
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of SHR-3167 at steady state in subjects with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities.
- •Age 18~59 years at screening (including cut-off values at both ends).
- •Confirmed diagnosis of type 2 diabetes mellitus ≥ 6 months before screening.
- •Female subjects of childbearing potential and their partners are male subjects of childbearing potential, who have no fertility plan and agree to take high-efficiency contraceptive measures within 3 months after signing the informed consent form and have no plans to donate eggs/sperm; Female subjects of childbearing potential have a negative pregnancy test during the screening period and are not lactating.
排除标准
- •Poor blood pressure control at screening.
- •Known or suspected allergy to investigational drug products or related products; or a history of multiple and/or severe allergies to drugs or foods.
- •Serious cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- •Positive test for hepatitis B surface antigen (HBsAg), HIV antibody, treponema pallidum specific antibody, or hepatitis C virus antibody; or the investigator judges that the subject is in the incubation or active phase of the above infection.
- •Malignancy or history of malignancy within 5 years prior to screening.
- •Participation in any clinical trial of an approved or unapproved investigational drug/medical device within 90 days prior to screening.
- •Any other condition judged by the investigator to be likely to affect the subject's safety or interfere with the evaluation of trial results.
研究组 & 干预措施
SHR-3167 Group
Experimental
干预措施: SHR-3167 Injection (Drug)
SHR-3167 Group
Experimental
干预措施: Insulin Degludec Injection (Drug)
结局指标
主要结局
Area under the SHR-3167 concentration-time curve (AUC SHR-3167, tau, ss).
时间窗: From 0 to 168 hours after SHR-3167 administration.
次要结局
- Adverse events (AEs).(21 weeks to 43 weeks.)
- Hypoglycemic events.(21 weeks to 43 weeks.)
- Maximum observed SHR-3167 concentration (Cmax, ss).(From 0 to 168 hours after SHR-3167 administration.)
研究者
研究点 (1)
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