A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance, PK and PD Parameters of Single Dose Escalation of GZR33 and Single Administration of GZR101 in Healthy Male Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AE)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Voluntarily participated in the study and signed the informed consent form (ICF);
- •Chinese healthy male adult subjects, aged 18-45 years old (both inclusive) at the time of signing the ICF;
- •3.Body mass index [BMI= weight (kg)/height (m) 2] at screening between 19.0 and 24.0 kg/m2, inclusive, a body weight ≥50 kg；
排除标准
- •Abnormalities assessed by the investigator to be clinically significant while screening: vital signs, physical examination, laboratory examination, anterior and lateral chest X-ray and 12-lead ECG;
- •Known severe allergy (such as allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, and allergy requiring glucocorticoid treatment) or known history of allergy to the drug ingredients used in this study;
- •Participants who have smoked more than 5 cigarettes per day within 3 months before screening, smoked within 48 h before using the investigational drug, or impossibly stopped using any tobacco products during the test;
- •4.History of drug abuse or drug abuse before screening, or positive results in alcohol testing and urine drug screening (morphine, methamphetamine, methadone, phencycldine piperidine, tetrahydrocannabinol acid, cocaine) while screening;
- •Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive.
研究组 & 干预措施
GZR33 Injection
Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)
干预措施: GZR33 Injection (Drug)
GZR33 Injection
Participants will receive GZR33 Injection or placebo, s.c. a single dose (Part A)
干预措施: Placebo (Drug)
GZR101 Injection
Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)
干预措施: GZR101 Injection (Drug)
GZR101 Injection
Participants will receive GZR101 Injection or placebo, s.c. a single dose (Part B)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AE)
时间窗: From Predose to Day14 after a single dose
Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.
次要结局
- AUCIAsp，0-12 h(From 0 hours to 12 hours after a single dose)
- GIRmax(From 0 hours to 24 hours after a single dose)
- AUCGZR33,0-24 h(From Predose to Day8 after a single dose)