A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.
详细描述
The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. The study consists of 1-2 cohort . 32 patients are planned to be included in each cohort (24 patients receive study drug，8 patients receive placebo) Subjects will receive treatment for 20 weeks after screening and complete 4 weeks of safety follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese male or female subjects aged 18-60 years (both inclusive).
- •Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI)
- •≥30.0 kg/m2 at screening.
- •Weight change <5% in the past 3 months before screening.
排除标准
- •Fasting Plasma Glucose（FPG） ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
- •FPG <3.9 mmol/L at screening and/or a history of hypoglycemia.
- •History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
- •Abnormal Thyroid-Stimulating hormone(TSH), Serum Free Triiodothyronine（FT3）, Serum Free Thyroxine（FT4） or diagnosed thyroid dysfunction
- •History of multiple endocrine neoplasia syndrome type 2 (MEN-2) , medullary thyroid carcinoma (MTC) or Category 4 and above thyroid nodules by Thyroid ultrasound Chinese Ultrasound Thyroid Imaging Reporting and Data System （C-TIRADS）
- •Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
- •Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening or randomization.
- •Time history from the starting point of P-wave to the starting point of QRS wave（PR intervals ）> 210 msec and/or QRS complex（QRS） > 120 msec and/or Corrected QT Interval（QTcF） > 450 msec at screening or randomization.
- •Serum amylase or lipase > 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
- •Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.
- •Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening
- •History of bariatric surgery for weight loss before screening.
研究组 & 干预措施
PB-119
PB-119 administered on the first day of week 1-20 according to the dose-escalation design
干预措施: PB-119 (Drug)
Placebo
Matched placebo administered on the first day of week 1-20 according to the dose-escalation design
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (24 week)
次要结局
- Pharmacokinetic profile(From the first dose (Day 1 ) of study drug until 20 week)
- Effectiveness index(week 20)