A Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of HZBio1 in Healthy Chinese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cmax of HZBio1
研究概览
简要总结
This randomized study will evaluate the safety, tolerability ,pharmacokinetics, pharmacodynamics and Immunogenicity of single ascending intramuscularly administered doses of HZBio1 in healthy volunteers.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fully informed and signed informed consent form;
- •Healthy subjects, male and female;
- •At the time of signing the informed consent, they were over 18-45 years old (including 18 and 45 years old) and weighed more than 50 kg,
- •Body mass index ranged from 19 to 26 (including 19 and 26) [body mass index (BMI) = body weight (kg) / height 2 (M2)];
- •The results of serum pregnancy test in women of childbearing age were negative;
- •The subjects agreed to use effective contraception or abstinence during the study period and within 6 months after the end of the study;
- •Be able to understand and comply with the clinical protocol requirements, and it is expected to complete the whole trial process.
排除标准
- •History of hypertension or abnormal blood pressure at screening / baseline (SBP > 140 mmHg and / or DBP > 90 mmHg confirmed twice a day)
- •According to the researcher's judgment (clinical urine routine examination, proteinuria 2 + and above), proteinuria or proteinuria history with clinical significance.
- •Any previous VEGF and VEGFR antibody or protein therapy within one year.
- •No biological products or live virus vaccine shall be used for treatment for 3 months before the first administration of the study drug, or any monoclonal antibody shall be used for 12 months.
- •History or evidence of hereditary bleeding, coagulopathy, or thrombosis.
- •History of gastrointestinal perforation or fistula.
- •Severe, unhealed wounds, active ulcers, or untreated fractures, or were randomly assigned or expected to require major surgery during the course of the study or within 2 months after the last administration of the study drug.
- •RX or OTC drugs or nutritional supplements were used within 5 half lives before the first administration of the study drug or within 2 weeks (depending on the longer period). Herbal supplements need to be discontinued 28 days before the first administration of the study drug.
- •HBsAg, HCV antibody, HIV antibody and syphilis were positive
- •Known allergy to bevacizumab or any excipient
- •Known allergic diseases or allergic constitution
- •There was a history of unpaid blood donation within 3 months before taking the study drug for the first time
- •Use any other study drug for treatment or participate in other clinical trials within 3 months before screening
- •There was a history of alcohol or drug abuse within 12 months before screening; subjects were not able to control within 72 hours before and throughout the study
- •History of mental illness
- •During the study, the partner was expected to be pregnant.
- •During the study period, it did not conform to the clinical study protocol.
- •Other conditions not suitable for this study were considered by the researchers
研究组 & 干预措施
HZBio1 0.96mg/kg
Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.
干预措施: HZBio1 0.96mg / kg (Drug)
HZBio1 0.96mg/kg
Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.
干预措施: Placebo (Drug)
HZBio1 3mg/kg
Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.
干预措施: HZBio1 3mg / kg (Drug)
HZBio1 3mg/kg
Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.
干预措施: Placebo (Drug)
HZBio1 6mg/kg
Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.
干预措施: HZBio1 6mg / kg (Drug)
HZBio1 6mg/kg
Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.
干预措施: Placebo (Drug)
HZBio1 9mg/kg
Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.
干预措施: HZBio1 9mg / kg (Drug)
HZBio1 9mg/kg
Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.
干预措施: Placebo (Drug)
HZBio1 12mg/kg
Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.
干预措施: HZBio1 12mg / kg (Drug)
HZBio1 12mg/kg
Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.
干预措施: Placebo (Drug)
结局指标
主要结局
Cmax of HZBio1
时间窗: 36 days
peak concentration (Cmax)
Кel of HZBio1
时间窗: 36 days
Кel of HZBio1 (elimination constant)
Tmax of HZBio1
时间窗: 36 days
Time to peak (Tmax)
Percentage of Participants With Adverse Events (AEs)
时间窗: 36 days
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Number of anti PHC antibody
时间窗: 36 days
The changes of anti PHC antibody were observed before and after treatment.
serum uric acid level
时间窗: 36 days
The decrease of serum uric acid level after administration will be analyzed.
Number of anti peg antibody
时间窗: 36 days
The changes of anti peg antibody were observed before and after treatment.
Number of Participants Positive for Nab（Neutralizing Antibody）
时间窗: 36 days
The changes of neutralizing antibody were observed before and after treatment.
Т1/2 of HZBio1
时间窗: 36 days
Т1/2 of HZBio1 (half-life)
AUC0-t of HZBio1
时间窗: 36 days
AUC0-t of HZBio1 (the area under the Concentration vs. Time curve from 0 to t post-infusion)
次要结局
未报告次要终点