NCT06548815已完成1 期
A Single-center, Single-administration, Randomized, Placebo-controlled, Dose-escalation Trial Evaluated the Safety, Tolerability, PK, and PD Parameters of GZR4 in Healthy Male Adult Subjects
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2022年8月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Incidence of TEAE
研究概览
简要总结
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Chinese healthy male adult subjects aged 18-45 years old
- •Body mass index [BMI between 19.0-24.0 kg/m2
- •Hemoglobin A1c (HbA1c)≤6%
排除标准
- •Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
- •Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
- •Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
- •Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
- •Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening
研究组 & 干预措施
GZR4
Experimental
s.c, single dose
干预措施: GZR4 (Drug)
Placebo
Placebo Comparator
s.c, single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of TEAE
时间窗: Baseline to Day29
次要结局
- AUC0-last(Baseline to Day29)
- T1/2(Baseline to Day29)
- GIRmax(Day2-Day3)
- Cmax(Baseline to Day29)
- Tmax,GZR4(Baseline to Day29)
- AUC0-inf(Baseline to Day29)
- Tmax,GIR(Day2-Day3)
- AUCGIR(Day2-Day3/Day7-Day8)
研究者
研究点 (1)
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