NCT03072407已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Sequential Parallel Group, MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- the number of AEs and the finding from the physical examination, the abnormal lab results
研究概览
简要总结
This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group, MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four once-weekly subcutaneous doses of PB-119 to subjects with T2DM.
详细描述
Dose levels of 25 µg, 50 µg, 100 µg and 200 µg with a dosing regimen of once weekly for 4 consecutive weeks will be evaluated
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
- Single (Participant)
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
- •Patients in whom T2DM has been diagnosed for at least 3 months prior to screening and have not been taking any treatment but have made lifestyle modifications (i.e., diet and exercise) for at least 4 weeks or are taking metformin (with no change in the treatment including dose over the past 2 months).
- •In good general health as determined by the investigator at screening evaluation
- •Male and/or female subjects between the ages of 18 and 70 years, inclusive;
- •Are capable of giving informed consent and complying with study procedures;
- •Body Mass Index (BMI) of approximately 22 to 40 kg/m2;
- •Fasting C-peptide test result must be >0.4 nmol/L;
- •HbA1c ≥6.5 % and ≤12%;
- •Female subjects must have a negative urine pregnancy test result prior to enrollment.
- •Willing and able to adhere to study restrictions and to be confined at the clinical research center.
排除标准
- •Subjects with a personal or family history of medullary thyroid carcinoma (MTC) or in subjects with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
- •Screening fasting blood glucose ≤100 or ≥270 mg/dL
- •Type 1 diabetes mellitus, or latent autoimmune diabetes in adults; diabetic neuropathy, retinopathy or nephropathy;
- •Previous treatment with an approved or investigational GLP-1 mimetic;
- •Patients treated with any investigational drugs within 6 weeks of screening;
- •Subjects with pancreatitis;
- •Clinically significant gastrointestinal disorder
- •History or symptoms of clinically significant cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia,
- •Uncontrolled hypertension at screening;
- •History of clinically significant central nervous system disease including: transient ischemic attack, stroke, seizure disorder, depression,
- •History of liver disease
- •History of clinically significant renal disease
- •Uncontrolled severe dyslipidemia;
- •Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
- •A hospital admission or major surgery within 30 days prior to screening;
- •A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
- •A history of alcohol abuse according to medical history within 6 months prior to screening;
- •A positive screen for alcohol, or drugs of abuse;
- •An unwillingness or inability to comply with food and beverage restrictions during study participation;
- •Use of prescription or over-the-counter (OTC) medications, and herbal An
- •Unwillingness of male participants to use appropriate contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation. Sexual intercourse with pregnant or lactating women is prohibited
研究组 & 干预措施
PB-119 injection placebo
Placebo Comparator
totally 8 subjects will have PB-119 injection placebo once per weekly for 4 weeks.
干预措施: PB-119 injection placebo (Biological)
PB-119 injection 50ug
Experimental
totally 8 subjects will have PB-119 injection 50 ug once per weekly for 4 weeks
干预措施: PB-119 injection (Biological)
PB-119 injection 100ug
Experimental
totally 8 subjects will have PB-119 injection 100 ug once per weekly for 4 weeks
干预措施: PB-119 injection (Biological)
PB-119 injection 25ug
Experimental
totally 8 subjects will have PB-119 injection 25 ug once per weekly for 4 weeks
干预措施: PB-119 injection (Biological)
PB-119 injection 200ug
Experimental
totally 8 subjects will have PB-119 injection 200 ug once per weekly for 4 weeks
干预措施: PB-119 injection (Biological)
结局指标
主要结局
the number of AEs and the finding from the physical examination, the abnormal lab results
时间窗: accessed up to 4 weeks
include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory)
次要结局
- PB-119 blood plasma concentration(accessed up to 4 weeks)
- Insulin sensitivity (SI)(accessed up to 4 weeks)
- Disposition Index(accessed up to 4 weeks)
- Beta-cell Responsivity Index(accessed up to 4 weeks)
- PB-119 antibody(accessed up to 4 weeks)
研究者
研究点 (4)
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