A Randomized, Open Phase I Trial to Evaluate the Bioavailability, Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet and Evaluate the Effect of Meal Time on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerance of GZR18 Tablet in Chinese Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Relative bioavailability of GZR18 tablet
研究概览
简要总结
The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects sign informed consent voluntarily.
- •Age 18-55 at screening (both included)，male or female（male only for part A）.
- •At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg.
- •Female subjects were HCG negative at screening and baseline
排除标准
- •Female subjects who are pregnant or lactating at screening.
- •History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing.
- •Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening.
- •History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results.
- •Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.
研究组 & 干预措施
Experimental: Part B (multiple dose)
Drug:GZR18 tablet GZR18 tablet administered as two multiple dose cohorts, to test the different meal time effect.
Parallel assignment
干预措施: GZR18 (Drug)
Experimental: Part A (single dose)
Drug: GZR18 tablet Three single-dose cohorts of GZR18 tablet administered according to an ascending dose design. Progression to next dose will be based on safety evaluation. Sequential cohorts.
Active Comparator: GZR18 injection Single-dose administered s.c. (under the skin).
干预措施: GZR18 (Drug)
结局指标
主要结局
Relative bioavailability of GZR18 tablet
时间窗: 22 days and 35 days
Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%
ADA and NAb
时间窗: 22 days and 35 days
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
AE and SAE
时间窗: 22 days and 35 days
Incidence of Adverse Events and Severe Adverse Events
次要结局
- Cmax(22 days and 35 days)
- AUC0-t(22 days and 35 days)
- AUC0-24h(22 days and 35 days)