A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Administration of HM12470 in Subjects With Type 1 (T1DM) and Type 2 Diabetes Mellitus (T2DM)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence and severity of treatment emergent adverse events
研究概览
简要总结
The purpose of this study is to investigate safety, tolerability, pharmacokinetics (PK) ad pharmacodynamics (PD) of HM12470 after single injection in T1DM and T2DM patients.
详细描述
This study is designed to evaluate safety, tolerability, PK and PD of HM12470 after single administration in subjects with T1DM and T2DM. In some cohorts for this study, the safety, tolerability, PK and PD of HM12470 will be compared with that of commercially available insulin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM more than 12 monthM
- •Age ≥18 and ≤70 years
- •Body mass index between 18.0 and 35.0 kg/m2 inclusive.
- •Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- •Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
- •Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
- •Inclusion Criteria for T2DM:
- •T1DM more than 12 monthM
- •Age ≥18 and ≤70 years
- •Body mass index between 18.0 and 30.0 kg/m2 inclusive.
- •Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- •Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for >12 months. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bearing potential, the subject must be using an acceptable contraceptive method during and for during a period of 60 days after the last dose of Study Drug.
- •Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
排除标准
- •A subject who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
- •Recurrent major hypoglycemia or hypoglycemic unawareness or recent ketoacidosis
- •pregnant or lactating women
- •participation in an investigational study within 30 days prior to dosing
- •Clinically significant abnormal ECG at screening, as judged by the Investigator
研究组 & 干预措施
Cohort 2
Low dose of HM12470 (single dose, subcutaneous injection)
干预措施: HM12470 (Biological)
Cohort 1
Very low dose of HM12470 (single dose, subcutaneous injection)
干预措施: HM12470 (Biological)
Cohort 4
High dose of HM12470 (single dose, subcutaneous injection)
干预措施: HM12470 (Biological)
Cohort 3
Intermediate dose of HM12470 (single dose, subcutaneous injection)
干预措施: HM12470 (Biological)
Cohort 5
Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
干预措施: Active comparator (Biological)
Cohort 6
Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
干预措施: Active comparator (Biological)
Cohort 6
Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
干预措施: HM12470 (Biological)
Cohort 5
Active comparator and a selected dose of HM12470 (single dose, subcutaneous injection)
干预措施: HM12470 (Biological)
结局指标
主要结局
Incidence and severity of treatment emergent adverse events
时间窗: 1 month
次要结局
- Peak Plasma Concentration(Cmax) of HM12470 following a single dose(1 month)
- Area under the concentration-time curve (AUC) of HM12470 following a single dose(1 month)