Phase 1 Multicenter, Randomized, Double-Blind, Placebo Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Incidence and severity of adverse events including hypoglycemia
研究概览
简要总结
This study is a first-in-human randomized, double-blind (Investigator and subject), placebo controlled single ascending dose study that will enroll approximately 40 (6 active/2 placebo per dose group) adult male and female subjects with Type 2 Diabetes Mellitus (T2DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to sign a written informed consent and follow all study-related procedures;
- •Male and female subjects at least 18 years of age;
- •Male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their dose of study drug;
- •Body mass index ≤45 kg/m2;
- •Diagnosed with T2DM and who is currently taking a stable daily dose of a basal insulin (Lantus) plus at least one oral antihyperglycemic agent at a stable dose for 3 months prior to screening.
排除标准
- •Currently taking or have taken within 3 months prior to screening an approved or investigational GLP-1 analogue/agonist (e.g., Victoza®) or pramlintide;
- •Currently taking or have routinely taken, within 3 months prior to screening , a short-acting insulin;
- •Currently taking or have taken, within 3 months prior to screening, a long acting insulin other than Lantus®;
- •Known allergy to, or serious adverse effect caused by an approved, or investigational insulin product or any of its components;
- •Currently taking any of the following medications: thiazide or furosemide diuretics, beta-blockers, estrogens or other hormonal replacement therapy, or other chronic medications with known adverse effects on glucose tolerance levels unless the subject has been on stable doses of such agents for at least 2 months prior to screening and have no planned changes during the study period;
- •History of recurrent severe hypoglycemia (more than 2 episodes within the last 6 months prior to randomization or hypoglycemic unawareness;
- •Malignant disease defined as 1) any history of malignant melanoma or breast cancer and/or 2) history of other types of cancer within the last 5 years prior to screening;
- •Unstable cardiovascular disease defined as one or more of the following: History of stroke, transient ischemic attack, or myocardial infarction within 6 months prior to screening; History of or currently have New York Heart Association Class III-IV heart failure prior to screening; Uncontrolled/sustained hypertension; History or evidence of long QT syndrome or mean triplicate 12-lead electrocardiogram demonstrating QT interval;
- •Clinically significant renal and/or hepatic dysfunction;
- •Absolute requirement for corticosteroids or have received systemic steroids within 3 months prior to Randomization (V5, Day -1). Note: Use of inhaled or topical corticosteroids will be permitted;
- •Pregnant or lactating female subjects;
- •Known history of or active alcohol abuse or use of illicit drugs within 1 year prior to screening;
- •Positive screening for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies at V1;
- •Participating in any other study and have received any other investigational medication or device within 30 days prior to Visit
- •Other medical or psychiatric condition which, in the opinion of the Investigator, would place the subject at increased risk.
研究组 & 干预措施
PE0139 Injection
Single subcutaneous injection of PE0139, 40 mg/mL
干预措施: PE0139 Injection (Drug)
Placebo
Single subcutaneous injection of 0.9% Sodium Chloride (NaCl) (Placebo)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of adverse events including hypoglycemia
时间窗: As reported between Days -10 to 28
Safety will be evaluated by the incidence and severity of adverse events including hypoglycemia.
Change in Vital Signs from baseline (Day 0 Pre-dose)
时间窗: Vital signs Day 0, 1, 2, 3, 4, 5, 6, 7, 14 and 28
Safety will be evaluated by analyses of the change from baseline in vital signs.
Change in ECGs from baseline (Day -1)
时间窗: ECG Days 2 and 28
Safety will be evaluated by analyses of the change from baseline in 12-lead ECG.
Change in Safety Labs from baseline (Pre-dose)
时间窗: Safety Labs Days 0, 7 and 28
Safety will be evaluated by analyses of the safety laboratory parameters.
Incidence and severity of immunogenicity
时间窗: Immunogenicity Days 0, 7, 14 and 28
Safety will be evaluated by the incidence and severity of immunogenicity.
次要结局
- Pharmacokinetic Profile(Day 0, 1, 2, 3, 4, 5, 6, and 7)
- Pharmacodynamic Response(FPG Day -10, -4, 0, 1, 2, 3, 4, 5, 6, 7, and 28; 4-pt Glucose and CGM - Day -10 to -7, -6, -5, and -4 to 7)