A Single Center, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 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, placebo controlled, dose increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects.
详细描述
The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects. The study consists of three dose groups, each of which is planned to include 12 subjects (9 receiving the study drug and 3 receiving placebo), for a total of 36 patients. Subjects will receive 12 weeks（for cohort 1 and 2） or 18 weeks(for cohort 3) of treatment after screening and complete 8 weeks of safety follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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) ≥28.0 kg/m2 at screening.
- •Weight change <5% in the past 3 months before screening.
排除标准
- •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), free triiodothyronine(FT3), Free thyroxine(FT4) or diagnosed thyroid dysfunction
- •History of multiple endocrine neoplasia syndrome type 2 (MEN-2) or medullary thyroid carcinoma (MTC).
- •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.
- •PR intervals > 210 msec and/or QRS wave group time limit > 120 msec and/or Corrected QT interval using Fridericia's formula（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 1 year before screening.
研究组 & 干预措施
PB-718
Low dose level of PB-718 administered on the first day of week 1-12(for cohort 1 and 2) or week 1-18(for cohort 3) according to the dose-escalation design
Medium dose level of PB-718 administered on the first day of week 1-12(for cohort 1 and 2) or week 1-18(for cohort 3) according to the dose-escalation design
High dose level of PB-718 administered on the first day of week 1-12(for cohort 1 and 2) or week 1-18(for cohort 3) according to the dose-escalation design
干预措施: PB-718 (Drug)
Placebo
Matched placebo administered on the first day of week 1-12(for cohort 1 and 2) or week 1-18(for cohort 3) 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 (20 weeks for cohort 1 and cohort 2 or 26 weeks for cohort 3)
次要结局
- Pharmacokinetic profile(From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort 2) or week 18(for cohort3))
- Proportion of participants with ≥5% weight loss(week 12 (for cohort 1 and cohort2) or week 18(for cohort 3))
- Change in body weight from baseline(Week12(for cohort 1 and cohort 2) or week 18(for cohort 3))
- Change in Fasting Plasma Glucose(FPG) from baseline(week 12(for cohort 1 and cohort 2) or week 18(for cohort 3))