Phase Ib Clinical Study on the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of GZR33 and GZR101 in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- AUC0-24h
研究概览
简要总结
This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B.
Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection.
Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and 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);
- •2.Chinese healthy male adult subjects aged 18-45 years old (including 18 and 45 years old as of the date of signing the ICF);
- •3.During screening period, the body mass index (BMI) between 19.0 and 24.0 kg/m2, inclusive, and a body weight>50 kg (not containing 50kg).
排除标准
- •1.History of drug abuse within one year prior to screening.
- •2.History of alcohol abuse within 6 months prior to screening (alcohol abuse is defined as more than 14 units weekly: 1 unit of alcohol equals to 360 mL of beer, 150 mL of wine, or 45 mL of 40% alcohol).The subject who smoke more than 5 cigarettes per day within 3 months prior to screening, smoke within 48 h prior to the use of the investigational drug, and is unwilling to refrain from smoking and drinking during the trial period.
- •3.Allergic constitution, or history of bronchial asthma, hives, eczema and other allergic diseases (except mild asymptomatic seasonal allergy), or known allergy to the investigational drug or its excipients, hypersensitivity or intolerance.
- •4.Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, syphilis spiral test or human immunodeficiency virus (HIV) antibodies positive.
- •5.History of needle and blood sickness, and subject couldn't tolerate venipuncture for blood collection, or be difficult to collect blood.
研究组 & 干预措施
Part A
Part A : randomized, open-label, single-dose, two-sequence, two-period, cross-over
Single administration of GZR33, washout period of 14 days, followed by single administration of Insulin Degludec
Single administration of Insulin Degludec, washout period of 14 days, followed by single administration of GZR33
干预措施: GZR33 Injection (Drug)
Part A
Part A : randomized, open-label, single-dose, two-sequence, two-period, cross-over
Single administration of GZR33, washout period of 14 days, followed by single administration of Insulin Degludec
Single administration of Insulin Degludec, washout period of 14 days, followed by single administration of GZR33
干预措施: Insulin Degludec (Drug)
Part B
Part B: randomized, double-blind, placebo-controlled, multiple-dose, parallel
Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c.
Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c.
干预措施: GZR33 Injection (Drug)
Part B
Part B: randomized, double-blind, placebo-controlled, multiple-dose, parallel
Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c.
Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c.
干预措施: GZR101 Injection (Drug)
Part B
Part B: randomized, double-blind, placebo-controlled, multiple-dose, parallel
Drug: GZR33 Injection Participants will receive once daily GZR33 Injection or placebo for 6 days, s.c.
Drug: GZR101 Injection Participants will receive once daily GZR101 Injection or placebo for 6 days, s.c.
干预措施: Placebo (Drug)
结局指标
主要结局
AUC0-24h
时间窗: From 0 to 24 hours
Area under the plasma concentration-time curve from time 0 to 24 hours
Incidence of adverse events (AE)
时间窗: From Predose to Day12
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
- Cmax(From Predose to Day7)
- tmax(From Predose to Day7)
- AUC0-last(From Predose to Day7)