NCT01236404已完成1 期
Phase 1/2a, Randomized, Double-Blind Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Response of PB1023 Injection Following Single and Multiple Ascending Subcutaneous Doses in Adult Subjects With Type 2 Diabetes Mellitus (T2DM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Safety/Tolerability
研究概览
简要总结
Primary objective:
To evaluate the safety and tolerability of single and multiple ascending doses of PB1023 administered as a subcutaneous (SC) injection in adult subjects with T2DM.
Secondary objectives:
- To characterize the pharmacokinetic profile of PB1023 after single and multiple ascending doses of PB1023.
- To assess the pharmacodynamic response of various single and multiple doses of PB1023 (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in response to a liquid Mixed Meal Tolerance Test (MMTT).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or post menopausal or surgically sterile females age 18-75 years of age inclusive.
- •Diagnosed with T2DM for > or = 6 months with HbA1c > or = 6.0% but < or = 9.0% while taking stable doses of one oral antihyperglycemic agent but < or = 8.5% when taking two oral antihyperglycemic agents for up to a maximum of 3 months prior to screening.
- •Fasting Plasma glucose between 115 mg/dL and 269 mg/dL.
- •Fasting C-peptide of > or = 0.8 ng/mL.
- •BMI < or = 40 kg/m
- •Otherwise stable health except for T2DM.
排除标准
- •Currently taking a non-oral antihyperglycemic agent.
- •Have taken a PPARg agonist within 90 days of screening.
- •Known allergy to an approved or investigational GLP-1 receptor analog/agonist.
- •Unstable cardiovascular disease as defined in clinical protocol.
- •History, symptoms or signs of pancreatitis or severe gastrointestinal disease.
- •Personal or family history of medullary thyroid tumors history of Multiple Endocrine Neoplasia Syndrome Type
- •Poor glucose control as defined in clinical protocol.
- •Clinically significant renal and/or hepatic dysfunction as defined in clinical protocol.
- •Absolute requirement for corticosteroids or received systemic steroids within 90 days prior to PB1023 administration.
- •Pregnant or lactating females.
- •Known history or active alcohol or drug abuse within 12 months prior to screening.
- •Positive for HIV, Hepatitis B surface antigen or Hepatitis C antibodies.
- •Participating in any other study within 30 days prior to screening.
- •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
PB1023 Injection
Experimental
Subcutaneous injection PB1023
干预措施: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl) (Drug)
PB1023 Injection
Experimental
Subcutaneous injection PB1023
干预措施: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl) (Drug)
Placebo (0.9% Sodium Chloride Injection)
Placebo Comparator
Subcutaneous Injection Placebo
干预措施: Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl) (Drug)
Placebo (0.9% Sodium Chloride Injection)
Placebo Comparator
Subcutaneous Injection Placebo
干预措施: Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl) (Drug)
结局指标
主要结局
Safety/Tolerability
时间窗: Screening to Final Visit (up to approximately 10 weeks for SAD and 14 weeks for MAD)
Safety will be evaluated by analyses of incidence of adverse events of interest (possibly related to the class of drug) and other adverse events. Vital signs, ECGs and safety laboratory parameters will also be presented.
次要结局
- Pharmacokinetic Profile(SAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, 7, 10, 14, 21 and 28. MAD: Pre-dose, 1, 4, 8, and 12 hours post-dose and Day 1, 2, 3, 5, pre-dose Days 7, 14 and 21 and at 1, 4, 8, and 12 hours post-dose and Day 22, 23, 26, 28, 35, 42,)
- Pharmacodynamic Response(Fasting plasma glucose collected the day before dosing and with PK samples, excluding day of dosing. SAD MMTT to occur on day 0 and 2, MAD MMTT to occur on Day 0 and 22 with continuous glucose monitoring on Day -8/-7 to Day 0 and on Day 21 to Day 28.)
研究者
研究点 (3)
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